{
    "info": {
        "nct_id": "NCT03276676",
        "official_title": "[18F]Fluciclovine and [18F]FLT PET/CT Assessment of Primary High-Grade Brain Tumors",
        "inclusion_criteria": "* Two adult patient groups will be eligible for inclusion in this study:\n\nGroup A: Patients where there is compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present. Pathologic confirmation will occur with biopsy or surgery.\n\nPatients whose tumor is felt to be inoperable and a biopsy is performed but no surgery.\n\nPatients with a newly diagnosed primary malignant brain tumor (WHO Grade III or IV) who will be receiving chemoradiation and who either did not undergo surgical resection or underwent incomplete resection with residual tumor > 1.0 cm in greatest diameter by contrast MRI postoperatively.\n\nGroup B: Patients with pathologically proven malignant brain tumor (WHO Grade III or IV glial-based tumors) who have undergone chemoradiation and have MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation.\n\n* Patients must be 18 years or older for inclusion in this study. There is little experience with the safety of [18F]FLT or [18F]Fluciclovine in children, and the risks associated with radiation exposure may be increased for children under 18 years old as well.\n* Patients must document their willingness to be followed for at least 24 months after recruitment by signing informed consent documenting their agreement to have clinical endpoints and the results of histopathologic tissue analysis (when tissue becomes available from routine care) entered into a research database.\n* All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.\n* Determination of pregnancy status: Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to each set of [18F]FLT and [18F]Fluciclovine PET scans. A negative test will be necessary for such patients to undergo research PET imaging.\n* Pre-imaging laboratory tests must be performed within 28 days prior to the [18F]FLT imaging procedure. These must be less than 4.0 times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless clinically not relevant). In those instances where a laboratory value is outside of this range, then such a patient will be ineligible for enrollment unless at the discretion of the PI the abnormal lab value is of no clinical significance to the safety or integrity of the study results. . For follow-up scanning sessions after therapy has been instituted, laboratory testing will also be required due to the use of [18F]FLT. The patients have brain tumors and will have received chemoradiation; therefore, many routine laboratory tests may not be within the typical normal range. As such, a factor of 4.0 times above or below the upper or lower value for the normal range for any laboratory test will also be used to determine the acceptable range for the 2nd and possibly 3rd imaging time points (unless clinically not relevant as explained above). The baseline laboratory testing will include liver enzymes (ALT, AST), bilirubin (total), serum electrolytes, CBC with platelets, prothrombin time, partial thromboplastin time, BUN, and creatinine. For those patients receiving coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed 6 times the upper limit of the normal range. (Appendix E, Laboratory Study Results).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible.\n* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.\n* Patients who are pregnant or lactating or who suspect they might be pregnant. Serum pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile.\n* Adult patients who require monitored anesthesia for PET scanning.\n* Patients who are too claustrophobic to undergo PET scanning.\n* Known HIV positive patients due to the previous toxicity noted with [18F]FLT in this patient group.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Two adult patient groups will be eligible for inclusion in this study:",
                "criterions": [
                    {
                        "exact_snippets": "Two adult patient groups",
                        "criterion": "patient group",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": "adult"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Two adult patient groups",
                        "criterion": "patient group",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": "adult"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Patients whose tumor is felt to be inoperable and a biopsy is performed but no surgery.",
                "criterions": [
                    {
                        "exact_snippets": "tumor is felt to be inoperable",
                        "criterion": "tumor operability",
                        "requirement": {
                            "requirement_type": "operability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "biopsy is performed",
                        "criterion": "biopsy",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": "performed"
                        }
                    },
                    {
                        "exact_snippets": "no surgery",
                        "criterion": "surgery",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "tumor is felt to be inoperable",
                                "criterion": "tumor operability",
                                "requirement": {
                                    "requirement_type": "operability",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "biopsy is performed",
                                "criterion": "biopsy",
                                "requirement": {
                                    "requirement_type": "procedure",
                                    "expected_value": "performed"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "no surgery",
                        "criterion": "surgery",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Patients with a newly diagnosed primary malignant brain tumor (WHO Grade III or IV) who will be receiving chemoradiation and who either did not undergo surgical resection or underwent incomplete resection with residual tumor > 1.0 cm in greatest diameter by contrast MRI postoperatively.",
                "criterions": [
                    {
                        "exact_snippets": "newly diagnosed primary malignant brain tumor",
                        "criterion": "primary malignant brain tumor",
                        "requirement": {
                            "requirement_type": "diagnosis status",
                            "expected_value": "newly diagnosed"
                        }
                    },
                    {
                        "exact_snippets": "WHO Grade III or IV",
                        "criterion": "tumor grade",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": [
                                "WHO Grade III",
                                "WHO Grade IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "receiving chemoradiation",
                        "criterion": "chemoradiation",
                        "requirement": {
                            "requirement_type": "treatment",
                            "expected_value": "receiving"
                        }
                    },
                    {
                        "exact_snippets": "did not undergo surgical resection",
                        "criterion": "surgical resection",
                        "requirement": {
                            "requirement_type": "procedure",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "underwent incomplete resection",
                        "criterion": "surgical resection",
                        "requirement": {
                            "requirement_type": "completeness",
                            "expected_value": "incomplete"
                        }
                    },
                    {
                        "exact_snippets": "residual tumor > 1.0 cm in greatest diameter by contrast MRI postoperatively",
                        "criterion": "residual tumor size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.0,
                                "unit": "cm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "newly diagnosed primary malignant brain tumor",
                                                        "criterion": "primary malignant brain tumor",
                                                        "requirement": {
                                                            "requirement_type": "diagnosis status",
                                                            "expected_value": "newly diagnosed"
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "WHO Grade III or IV",
                                                        "criterion": "tumor grade",
                                                        "requirement": {
                                                            "requirement_type": "grade",
                                                            "expected_value": [
                                                                "WHO Grade III",
                                                                "WHO Grade IV"
                                                            ]
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "receiving chemoradiation",
                                                "criterion": "chemoradiation",
                                                "requirement": {
                                                    "requirement_type": "treatment",
                                                    "expected_value": "receiving"
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "did not undergo surgical resection",
                                                "criterion": "surgical resection",
                                                "requirement": {
                                                    "requirement_type": "procedure",
                                                    "expected_value": false
                                                }
                                            },
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "underwent incomplete resection",
                                                        "criterion": "surgical resection",
                                                        "requirement": {
                                                            "requirement_type": "completeness",
                                                            "expected_value": "incomplete"
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "residual tumor > 1.0 cm in greatest diameter by contrast MRI postoperatively",
                                                        "criterion": "residual tumor size",
                                                        "requirement": {
                                                            "requirement_type": "size",
                                                            "expected_value": {
                                                                "operator": ">",
                                                                "value": 1.0,
                                                                "unit": "cm"
                                                            }
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Group B: Patients with pathologically proven malignant brain tumor (WHO Grade III or IV glial-based tumors) who have undergone chemoradiation and have MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation.",
                "criterions": [
                    {
                        "exact_snippets": "pathologically proven malignant brain tumor",
                        "criterion": "malignant brain tumor",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "pathologically proven"
                        }
                    },
                    {
                        "exact_snippets": "WHO Grade III or IV glial-based tumors",
                        "criterion": "tumor grade",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": [
                                "WHO Grade III",
                                "WHO Grade IV"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "undergone chemoradiation",
                        "criterion": "chemoradiation",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression)",
                        "criterion": "recurrence/progression",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": "MRI-documented"
                        }
                    },
                    {
                        "exact_snippets": "within 6 months from the time of completion of chemoradiation",
                        "criterion": "time since chemoradiation",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "pathologically proven malignant brain tumor",
                                "criterion": "malignant brain tumor",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": "pathologically proven"
                                }
                            },
                            {
                                "exact_snippets": "WHO Grade III or IV glial-based tumors",
                                "criterion": "tumor grade",
                                "requirement": {
                                    "requirement_type": "grade",
                                    "expected_value": [
                                        "WHO Grade III",
                                        "WHO Grade IV"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "undergone chemoradiation",
                        "criterion": "chemoradiation",
                        "requirement": {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression)",
                        "criterion": "recurrence/progression",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": "MRI-documented"
                        }
                    },
                    {
                        "exact_snippets": "within 6 months from the time of completion of chemoradiation",
                        "criterion": "time since chemoradiation",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must be 18 years or older for inclusion in this study. There is little experience with the safety of [18F]FLT or [18F]Fluciclovine in children, and the risks associated with radiation exposure may be increased for children under 18 years old as well.",
                "criterions": [
                    {
                        "exact_snippets": "Patients must be 18 years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Patients must be 18 years or older",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must document their willingness to be followed for at least 24 months after recruitment by signing informed consent documenting their agreement to have clinical endpoints and the results of histopathologic tissue analysis (when tissue becomes available from routine care) entered into a research database.",
                "criterions": [
                    {
                        "exact_snippets": "willingness to be followed for at least 24 months",
                        "criterion": "follow-up duration",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 24,
                                "unit": "months"
                            }
                        }
                    },
                    {
                        "exact_snippets": "signing informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "agreement to have clinical endpoints ... entered into a research database",
                        "criterion": "clinical endpoints data entry",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "agreement to have ... results of histopathologic tissue analysis ... entered into a research database",
                        "criterion": "histopathologic tissue analysis data entry",
                        "requirement": {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "willingness to be followed for at least 24 months",
                                "criterion": "follow-up duration",
                                "requirement": {
                                    "requirement_type": "duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "signing informed consent",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "agreement to have clinical endpoints ... entered into a research database",
                                "criterion": "clinical endpoints data entry",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "agreement to have ... results of histopathologic tissue analysis ... entered into a research database",
                                "criterion": "histopathologic tissue analysis data entry",
                                "requirement": {
                                    "requirement_type": "agreement",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* All patients, or their legal guardians, must sign a written informed consent and HIPAA authorization in accordance with institutional guidelines.",
                "criterions": [
                    {
                        "exact_snippets": "All patients, or their legal guardians, must sign a written informed consent",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "HIPAA authorization",
                        "criterion": "HIPAA authorization",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "All patients, or their legal guardians, must sign a written informed consent",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "signed",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "All patients, or their legal guardians, must sign a written informed consent",
                                "criterion": "informed consent",
                                "requirement": {
                                    "requirement_type": "signed",
                                    "expected_value": true
                                }
                            }
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                    },
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                        "exact_snippets": "HIPAA authorization",
                        "criterion": "HIPAA authorization",
                        "requirement": {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Determination of pregnancy status: Female patients who are not postmenopausal or surgically sterile will undergo a serum pregnancy test prior to each set of [18F]FLT and [18F]Fluciclovine PET scans. A negative test will be necessary for such patients to undergo research PET imaging.",
                "criterions": [
                    {
                        "exact_snippets": "Determination of pregnancy status: Female patients who are not postmenopausal or surgically sterile ... A negative test will be necessary",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "exact_snippets": "Female patients who are not postmenopausal or surgically sterile",
                            "criterion": "menopausal or surgical sterility status",
                            "requirement": {
                                "requirement_type": "status",
                                "expected_value": "not postmenopausal or surgically sterile"
                            }
                        },
                        {
                            "exact_snippets": "Determination of pregnancy status: Female patients who are not postmenopausal or surgically sterile ... A negative test will be necessary",
                            "criterion": "pregnancy status",
                            "requirement": {
                                "requirement_type": "status",
                                "expected_value": "negative"
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Adult patients who require monitored anesthesia for PET scanning.",
                "criterions": [
                    {
                        "exact_snippets": "Adult patients",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "age group",
                            "expected_value": "adult"
                        }
                    },
                    {
                        "exact_snippets": "require monitored anesthesia",
                        "criterion": "anesthesia requirement",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "PET scanning",
                        "criterion": "procedure",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "PET scan"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Adult patients",
                                "criterion": "age",
                                "requirement": {
                                    "requirement_type": "age group",
                                    "expected_value": "adult"
                                }
                            },
                            {
                                "exact_snippets": "require monitored anesthesia",
                                "criterion": "anesthesia requirement",
                                "requirement": {
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                            }
                        ]
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                        "exact_snippets": "PET scanning",
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                            "requirement_type": "type",
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                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients who are too claustrophobic to undergo PET scanning.",
                "criterions": [
                    {
                        "exact_snippets": "Patients who are too claustrophobic to undergo PET scanning.",
                        "criterion": "claustrophobia",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "too severe for PET scanning"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Patients who are too claustrophobic to undergo PET scanning.",
                    "criterion": "claustrophobia",
                    "requirement": {
                        "requirement_type": "severity",
                        "expected_value": "too severe for PET scanning"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Known HIV positive patients due to the previous toxicity noted with [18F]FLT in this patient group.",
                "criterions": [
                    {
                        "exact_snippets": "Known HIV positive patients",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Known HIV positive patients",
                        "criterion": "HIV status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "Group A: Patients where there is compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present. Pathologic confirmation will occur with biopsy or surgery.",
                "criterions": [
                    {
                        "exact_snippets": "compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present",
                        "criterion": "high-grade primary brain tumor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Pathologic confirmation will occur with biopsy or surgery",
                        "criterion": "pathologic confirmation",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": [
                                "biopsy",
                                "surgery"
                            ]
                        }
                    }
                ]
            },
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                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present",
                                        "criterion": "high-grade primary brain tumor",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "Pathologic confirmation will occur with biopsy or surgery",
                                        "criterion": "pathologic confirmation",
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                                            "requirement_type": "method",
                                            "expected_value": [
                                                "biopsy"
                                            ]
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                                    }
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                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "compelling evidence, based on the MRI and/or CT imaging, that a high-grade primary brain tumor is present",
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                                        "requirement": {
                                            "requirement_type": "presence",
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                                    },
                                    {
                                        "exact_snippets": "Pathologic confirmation will occur with biopsy or surgery",
                                        "criterion": "pathologic confirmation",
                                        "requirement": {
                                            "requirement_type": "method",
                                            "expected_value": [
                                                "surgery"
                                            ]
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                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Pre-imaging laboratory tests must be performed within 28 days prior to the [18F]FLT imaging procedure. These must be less than 4.0 times below or above the upper or lower limit range for the respective laboratory test for entry into the study (unless clinically not relevant). In those instances where a laboratory value is outside of this range, then such a patient will be ineligible for enrollment unless at the discretion of the PI the abnormal lab value is of no clinical significance to the safety or integrity of the study results. . For follow-up scanning sessions after therapy has been instituted, laboratory testing will also be required due to the use of [18F]FLT. The patients have brain tumors and will have received chemoradiation; therefore, many routine laboratory tests may not be within the typical normal range. As such, a factor of 4.0 times above or below the upper or lower value for the normal range for any laboratory test will also be used to determine the acceptable range for the 2nd and possibly 3rd imaging time points (unless clinically not relevant as explained above). The baseline laboratory testing will include liver enzymes (ALT, AST), bilirubin (total), serum electrolytes, CBC with platelets, prothrombin time, partial thromboplastin time, BUN, and creatinine. For those patients receiving coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed 6 times the upper limit of the normal range. (Appendix E, Laboratory Study Results).",
                "criterions": [
                    {
                        "exact_snippets": "Pre-imaging laboratory tests must be performed within 28 days prior to the [18F]FLT imaging procedure.",
                        "criterion": "pre-imaging laboratory tests timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "These must be less than 4.0 times below or above the upper or lower limit range for the respective laboratory test for entry into the study",
                        "criterion": "laboratory test range",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 4.0,
                                        "unit": "times"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "baseline laboratory testing will include liver enzymes (ALT, AST)",
                        "criterion": "liver enzymes (ALT, AST)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "baseline laboratory testing will include ... bilirubin (total)",
                        "criterion": "bilirubin (total)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "baseline laboratory testing will include ... serum electrolytes",
                        "criterion": "serum electrolytes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "baseline laboratory testing will include ... CBC with platelets",
                        "criterion": "CBC with platelets",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "baseline laboratory testing will include ... prothrombin time",
                        "criterion": "prothrombin time",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "baseline laboratory testing will include ... partial thromboplastin time",
                        "criterion": "partial thromboplastin time",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "baseline laboratory testing will include ... BUN",
                        "criterion": "BUN",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "baseline laboratory testing will include ... creatinine",
                        "criterion": "creatinine",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "For those patients receiving coumadin or another anticoagulant the upper limit for prothrombin time or partial thromboplastin time must not exceed 6 times the upper limit of the normal range.",
                        "criterion": "prothrombin time or partial thromboplastin time for patients on anticoagulants",
                        "requirement": {
                            "requirement_type": "upper limit",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "times"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible.",
                "criterions": [
                    {
                        "exact_snippets": "clinically significant signs of uncal herniation",
                        "criterion": "uncal herniation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "acute pupillary enlargement",
                        "criterion": "acute pupillary enlargement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "rapidly developing motor changes (over hours)",
                        "criterion": "rapidly developing motor changes",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "rapidly decreasing level of consciousness",
                        "criterion": "rapidly decreasing level of consciousness",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune diseases may be enrolled at the Investigator's discretion.",
                "criterions": [
                    {
                        "exact_snippets": "known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals",
                        "criterion": "allergic or hypersensitivity reactions to radiopharmaceuticals",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "significant drug or other allergies",
                        "criterion": "significant drug or other allergies",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "at Investigator's discretion"
                        }
                    },
                    {
                        "exact_snippets": "autoimmune diseases",
                        "criterion": "autoimmune diseases",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "at Investigator's discretion"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* Patients who are pregnant or lactating or who suspect they might be pregnant. Serum pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile.",
                "criterions": [
                    {
                        "exact_snippets": "Patients who are pregnant",
                        "criterion": "pregnancy status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "pregnant"
                        }
                    },
                    {
                        "exact_snippets": "lactating",
                        "criterion": "lactation status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "lactating"
                        }
                    },
                    {
                        "exact_snippets": "suspect they might be pregnant",
                        "criterion": "pregnancy suspicion",
                        "requirement": {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Serum pregnancy tests ... female patients that are not postmenopausal or surgically sterile",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}