{
    "info": {
        "nct_id": "NCT03863457",
        "official_title": "Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer",
        "inclusion_criteria": "* Participants will be ≥ 18 years of age\n* Known or suspected primary or metastatic breast cancer.\n* At least one lesion ≥ 1.5 cm that is seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT). Only one type of imaging is required to show a lesion.\n* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Females who are pregnant or breast feeding at the time of screening; a urine pregnancy test will be performed in women of child-bearing potential at screening.\n* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.\n* Any current medical condition, illness, or disorder, as assessed by medical record review and/or self-reported, that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Participants will be ≥ 18 years of age",
                "criterions": [
                    {
                        "exact_snippets": "Participants will be ≥ 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Participants will be ≥ 18 years of age",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.",
                "criterions": [
                    {
                        "exact_snippets": "Participants must be informed of the investigational nature of this study",
                        "criterion": "informed of investigational nature",
                        "requirement": {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "be willing to provide written informed consent",
                        "criterion": "written informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "participate in this study in accordance with institutional and federal guidelines",
                        "criterion": "participation in accordance with guidelines",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Participants must be informed of the investigational nature of this study",
                        "criterion": "informed of investigational nature",
                        "requirement": {
                            "requirement_type": "awareness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "be willing to provide written informed consent",
                        "criterion": "written informed consent",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "participate in this study in accordance with institutional and federal guidelines",
                        "criterion": "participation in accordance with guidelines",
                        "requirement": {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "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": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "* Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.",
                "criterions": [
                    {
                        "exact_snippets": "Inability to tolerate imaging procedures",
                        "criterion": "tolerance to imaging procedures",
                        "requirement": {
                            "requirement_type": "tolerance",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Inability to tolerate imaging procedures",
                                "criterion": "tolerance to imaging procedures",
                                "requirement": {
                                    "requirement_type": "tolerance",
                                    "expected_value": false
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "Inability to tolerate imaging procedures",
                                        "criterion": "opinion of investigator",
                                        "requirement": {
                                            "requirement_type": "opinion",
                                            "expected_value": "inability to tolerate"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Inability to tolerate imaging procedures",
                                        "criterion": "opinion of treating physician",
                                        "requirement": {
                                            "requirement_type": "opinion",
                                            "expected_value": "inability to tolerate"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any current medical condition, illness, or disorder, as assessed by medical record review and/or self-reported, that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.",
                "criterions": [
                    {
                        "exact_snippets": "Any current medical condition, illness, or disorder ... that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.",
                        "criterion": "medical condition, illness, or disorder",
                        "requirement": {
                            "requirement_type": "impact on safety or participation",
                            "expected_value": "could compromise participant safety or successful participation in the study"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any current medical condition, illness, or disorder ... that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.",
                                "criterion": "medical condition, illness, or disorder",
                                "requirement": {
                                    "requirement_type": "impact on safety or participation",
                                    "expected_value": "could compromise participant safety or successful participation in the study"
                                }
                            },
                            {
                                "exact_snippets": "Any current medical condition, illness, or disorder ... that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.",
                                "criterion": "medical condition, illness, or disorder",
                                "requirement": {
                                    "requirement_type": "assessment method",
                                    "expected_value": [
                                        "medical record review",
                                        "self-reported"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Any current medical condition, illness, or disorder ... that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.",
                        "criterion": "medical condition, illness, or disorder",
                        "requirement": {
                            "requirement_type": "consideration by physician",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "* Known or suspected primary or metastatic breast cancer.",
                "criterions": [
                    {
                        "exact_snippets": "Known or suspected primary ... breast cancer.",
                        "criterion": "primary breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Known or suspected ... metastatic breast cancer.",
                        "criterion": "metastatic breast cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "* At least one lesion ≥ 1.5 cm that is seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT). Only one type of imaging is required to show a lesion.",
                "criterions": [
                    {
                        "exact_snippets": "At least one lesion ≥ 1.5 cm",
                        "criterion": "lesion size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "cm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT)",
                        "criterion": "lesion visibility on imaging",
                        "requirement": {
                            "requirement_type": "imaging types",
                            "expected_value": [
                                "CT",
                                "MRI",
                                "mammogram",
                                "ultrasound",
                                "FDG-PET/CT"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Only one type of imaging is required to show a lesion",
                        "criterion": "imaging requirement",
                        "requirement": {
                            "requirement_type": "number of imaging types required",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "At least one lesion ≥ 1.5 cm",
                                "criterion": "lesion size",
                                "requirement": {
                                    "requirement_type": "size",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "cm"
                                    }
                                }
                            },
                            {
                                "or_criteria": [
                                    {
                                        "exact_snippets": "seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT)",
                                        "criterion": "lesion visibility on imaging",
                                        "requirement": {
                                            "requirement_type": "imaging types",
                                            "expected_value": "CT"
                                        }
                                    },
                                    {
                                        "exact_snippets": "seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT)",
                                        "criterion": "lesion visibility on imaging",
                                        "requirement": {
                                            "requirement_type": "imaging types",
                                            "expected_value": "MRI"
                                        }
                                    },
                                    {
                                        "exact_snippets": "seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT)",
                                        "criterion": "lesion visibility on imaging",
                                        "requirement": {
                                            "requirement_type": "imaging types",
                                            "expected_value": "mammogram"
                                        }
                                    },
                                    {
                                        "exact_snippets": "seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT)",
                                        "criterion": "lesion visibility on imaging",
                                        "requirement": {
                                            "requirement_type": "imaging types",
                                            "expected_value": "ultrasound"
                                        }
                                    },
                                    {
                                        "exact_snippets": "seen on standard imaging (e.g. CT, MRI, mammogram, ultrasound, FDG-PET/CT)",
                                        "criterion": "lesion visibility on imaging",
                                        "requirement": {
                                            "requirement_type": "imaging types",
                                            "expected_value": "FDG-PET/CT"
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Only one type of imaging is required to show a lesion",
                        "criterion": "imaging requirement",
                        "requirement": {
                            "requirement_type": "number of imaging types required",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "* Females who are pregnant or breast feeding at the time of screening; a urine pregnancy test will be performed in women of child-bearing potential at screening.",
                "criterions": [
                    {
                        "exact_snippets": "Females who are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast feeding at the time of screening",
                        "criterion": "breastfeeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "a urine pregnancy test will be performed in women of child-bearing potential at screening",
                        "criterion": "urine pregnancy test",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": "performed"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Females who are pregnant",
                                "criterion": "pregnancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "breast feeding at the time of screening",
                                "criterion": "breastfeeding",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "a urine pregnancy test will be performed in women of child-bearing potential at screening",
                        "criterion": "urine pregnancy test",
                        "requirement": {
                            "requirement_type": "requirement",
                            "expected_value": "performed"
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}