{
    "info": {
        "nct_id": "NCT03539731",
        "official_title": "A Phase I Study of [18F]DASA-23 as a PET Tracer for Evaluating Pyruvate Kinase M2 (PKM2) Expression in Healthy Volunteers and in Patients With Intracranial Tumors",
        "inclusion_criteria": "Age ≥18 years old.\n\n2. Adequate organ function (obtained within 14 days prior to PET scan [Part 1, Part 2, and Part 3 ONLY] or within 28 days prior to PET scan [Part 4 ONLY]) as evidenced by:\n\n1. ANC ≥ 1.5 X 10^9/L w/o myeloid growth factor support for 7 d preceding lab assessment\n2. Hgb ≥ 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if Hgb is corrected to ≥ 9 g/dL (90 g/L) as by growth factor or transfusion prior to PET scan\n3. Platelet count ≥ 100 X 10^9/L w/o blood transfusions for 7 d preceding lab assessment\n4. Bilirubin ≤ 1.5 X ULN except for pts w/ documented history of Gilbert's disease\n5. ALT and AST ≤ 2.5 X ULN\n6. Alkaline phosphatase (AP) ≤ 3 X ULN\n7. Women of childbearing potential (WCBP): negative serum pregnancy test\n\n   3. Ability to stand up and climb two steps with minimal assistance.\n\n   4. Ability to understand and the willingness to sign a written informed consent document.\n\n   5. (Part 2, intracranial tumor patients ONLY) (a) Radiographical or pathological evidence of newly-diagnosed intracranial tumor that is status-pre surgical resection, or (b) Radiographical or pathological evidence of progressive/recurrent intracranial tumor, (c) Question of pseudoprogression vs. true progression on most recent standard-of-care brain MRI, or (d) Evidence on the most recent standard-of-care brain MRI scan of intracranial metastasis/metastases in a patient with known extracranial primary cancer.\n\n   6. (Part 3, GBM patients ONLY) Any patient with at least a 1cm3 contrast-enhancing lesion suspicious for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM, molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or any other WHO Grade IV glioma) on a standard-of-care (SOC) brain MRI scan. If the patient undergoes a biopsy or resection for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM, molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or any other WHO Grade IV glioma) then the remaining contrast-enhancing lesion is at least 1cm3 in size on the post-operative scan.\n\n   7. (Part 3, GBM patients ONLY) Life expectancy of ≥ 6 months.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Known allergy to adhesive tapes or other skin adhesives used in medical care\n2. Subjects with the following co-morbid disease or incurrent illness:\n\n   1. With known cirrhosis diagnosed with Child-Pugh Class A or higher liver disease.\n   2. Severe/uncontrolled inter-current illness within the previous 28 days prior to PET scan\n   3. Patients who have implantable devices that are contra-indicated for MRI\n   4. Bleeding disorder\n   5. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation.\n   6. (Healthy volunteers ONLY - Part 1 and Part 4) prior or current malignancy\n   7. (Healthy volunteers ONLY - Part 1 and Part 4) known kidney disease\n3. Pregnant or nursing participants\n4. History of allergic reactions to gadolinium-based MRI contrast agent\n5. (Part 2, intracranial tumor patients ONLY) Other chemotherapy (besides what is being used to treat the intracranial tumor)\n6. (Part 3, GBM patients ONLY) Has already begun therapy, prior to the first of two [18F]DASA-23 PET/MRI scans.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Age ≥18 years old.",
            "criterions": [
                {
                    "exact_snippets": "Age ≥18 years old.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Adequate organ function (obtained within 14 days prior to PET scan [Part 1, Part 2, and Part 3 ONLY] or within 28 days prior to PET scan [Part 4 ONLY]) as evidenced by:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "obtained within 14 days prior to PET scan [Part 1, Part 2, and Part 3 ONLY]",
                    "criterion": "organ function test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "obtained ... within 28 days prior to PET scan [Part 4 ONLY]",
                    "criterion": "organ function test timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. ANC ≥ 1.5 X 10^9/L w/o myeloid growth factor support for 7 d preceding lab assessment",
            "criterions": [
                {
                    "exact_snippets": "ANC ≥ 1.5 X 10^9/L",
                    "criterion": "ANC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "X 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "w/o myeloid growth factor support for 7 d preceding lab assessment",
                    "criterion": "myeloid growth factor support",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Hgb ≥ 9 g/dL (90 g/L); < 9 g/dL (< 90 g/L) is acceptable if Hgb is corrected to ≥ 9 g/dL (90 g/L) as by growth factor or transfusion prior to PET scan",
            "criterions": [
                {
                    "exact_snippets": "Hgb ≥ 9 g/dL (90 g/L)",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "< 9 g/dL (< 90 g/L) is acceptable if Hgb is corrected to ≥ 9 g/dL (90 g/L) as by growth factor or transfusion",
                    "criterion": "hemoglobin level correction",
                    "requirements": [
                        {
                            "requirement_type": "correction",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Platelet count ≥ 100 X 10^9/L w/o blood transfusions for 7 d preceding lab assessment",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100 X 10^9/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "X 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "w/o blood transfusions for 7 d preceding lab assessment",
                    "criterion": "blood transfusions",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time period",
                            "expected_value": "7 days preceding lab assessment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Bilirubin ≤ 1.5 X ULN except for pts w/ documented history of Gilbert's disease",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin ≤ 1.5 X ULN",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for pts w/ documented history of Gilbert's disease",
                    "criterion": "Gilbert's disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. ALT and AST ≤ 2.5 X ULN",
            "criterions": [
                {
                    "exact_snippets": "ALT ... ≤ 2.5 X ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST ≤ 2.5 X ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Alkaline phosphatase (AP) ≤ 3 X ULN",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase (AP) ≤ 3 X ULN",
                    "criterion": "alkaline phosphatase (AP)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "X ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Women of childbearing potential (WCBP): negative serum pregnancy test",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential (WCBP): negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Ability to stand up and climb two steps with minimal assistance.",
            "criterions": [
                {
                    "exact_snippets": "Ability to stand up",
                    "criterion": "ability to stand up",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "climb two steps with minimal assistance",
                    "criterion": "ability to climb two steps",
                    "requirements": [
                        {
                            "requirement_type": "assistance level",
                            "expected_value": "minimal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Ability to understand and the willingness to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Ability to understand",
                    "criterion": "cognitive ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. (Part 2, intracranial tumor patients ONLY) (a) Radiographical or pathological evidence of newly-diagnosed intracranial tumor that is status-pre surgical resection, or (b) Radiographical or pathological evidence of progressive/recurrent intracranial tumor, (c) Question of pseudoprogression vs. true progression on most recent standard-of-care brain MRI, or (d) Evidence on the most recent standard-of-care brain MRI scan of intracranial metastasis/metastases in a patient with known extracranial primary cancer.",
            "criterions": [
                {
                    "exact_snippets": "Radiographical or pathological evidence of newly-diagnosed intracranial tumor",
                    "criterion": "newly-diagnosed intracranial tumor",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "radiographical",
                                "pathological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "status-pre surgical resection",
                    "criterion": "surgical resection status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "pre-surgical resection"
                        }
                    ]
                },
                {
                    "exact_snippets": "Radiographical or pathological evidence of progressive/recurrent intracranial tumor",
                    "criterion": "progressive/recurrent intracranial tumor",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "radiographical",
                                "pathological"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Question of pseudoprogression vs. true progression on most recent standard-of-care brain MRI",
                    "criterion": "pseudoprogression vs. true progression",
                    "requirements": [
                        {
                            "requirement_type": "question",
                            "expected_value": "on most recent standard-of-care brain MRI"
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence on the most recent standard-of-care brain MRI scan of intracranial metastasis/metastases",
                    "criterion": "intracranial metastasis/metastases",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "on the most recent standard-of-care brain MRI scan"
                        }
                    ]
                },
                {
                    "exact_snippets": "in a patient with known extracranial primary cancer",
                    "criterion": "extracranial primary cancer",
                    "requirements": [
                        {
                            "requirement_type": "knowledge",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. (Part 3, GBM patients ONLY) Any patient with at least a 1cm3 contrast-enhancing lesion suspicious for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM, molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or any other WHO Grade IV glioma) on a standard-of-care (SOC) brain MRI scan. If the patient undergoes a biopsy or resection for GBM (either newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM, molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or any other WHO Grade IV glioma) then the remaining contrast-enhancing lesion is at least 1cm3 in size on the post-operative scan.",
            "criterions": [
                {
                    "exact_snippets": "at least a 1cm3 contrast-enhancing lesion",
                    "criterion": "contrast-enhancing lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "suspicious for GBM",
                    "criterion": "suspicion for GBM",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "newly-diagnosed or 1st /2nd/ 3rd recurrence of GBM, molecular GBM, diffuse astrocytomas with molecular features of GBM, H3K27M midline gliomas, gliosarcomas, or any other WHO Grade IV glioma",
                    "criterion": "GBM or related glioma type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "newly-diagnosed GBM",
                                "1st recurrence of GBM",
                                "2nd recurrence of GBM",
                                "3rd recurrence of GBM",
                                "molecular GBM",
                                "diffuse astrocytomas with molecular features of GBM",
                                "H3K27M midline gliomas",
                                "gliosarcomas",
                                "any other WHO Grade IV glioma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "standard-of-care (SOC) brain MRI scan",
                    "criterion": "SOC brain MRI scan",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "SOC brain MRI scan"
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoes a biopsy or resection for GBM",
                    "criterion": "biopsy or resection for GBM",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": [
                                "biopsy",
                                "resection"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "remaining contrast-enhancing lesion is at least 1cm3 in size on the post-operative scan",
                    "criterion": "post-operative contrast-enhancing lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "cm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. (Part 3, GBM patients ONLY) Life expectancy of ≥ 6 months.",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of ≥ 6 months.",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Known allergy to adhesive tapes or other skin adhesives used in medical care",
            "criterions": [
                {
                    "exact_snippets": "Known allergy to adhesive tapes or other skin adhesives",
                    "criterion": "allergy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "substance",
                            "expected_value": [
                                "adhesive tapes",
                                "skin adhesives"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Subjects with the following co-morbid disease or incurrent illness:",
            "criterions": [
                {
                    "exact_snippets": "co-morbid disease or incurrent illness",
                    "criterion": "co-morbid disease or incurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. With known cirrhosis diagnosed with Child-Pugh Class A or higher liver disease.",
            "criterions": [
                {
                    "exact_snippets": "known cirrhosis",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Child-Pugh Class A or higher liver disease",
                    "criterion": "liver disease severity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "Child-Pugh Class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Severe/uncontrolled inter-current illness within the previous 28 days prior to PET scan",
            "criterions": [
                {
                    "exact_snippets": "Severe/uncontrolled inter-current illness",
                    "criterion": "inter-current illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within the previous 28 days prior to PET scan",
                    "criterion": "time since illness",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients who have implantable devices that are contra-indicated for MRI",
            "criterions": [
                {
                    "exact_snippets": "Patients who have implantable devices that are contra-indicated for MRI",
                    "criterion": "implantable devices",
                    "requirements": [
                        {
                            "requirement_type": "contra-indication for MRI",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Bleeding disorder",
            "criterions": [
                {
                    "exact_snippets": "Bleeding disorder",
                    "criterion": "bleeding disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Any other significant co-morbid conditions that in the opinion of the Investigator would impair study participation or cooperation.",
            "criterions": [
                {
                    "exact_snippets": "Any other significant co-morbid conditions",
                    "criterion": "co-morbid conditions",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "impact on study participation",
                            "expected_value": "would impair study participation or cooperation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. (Healthy volunteers ONLY - Part 1 and Part 4) prior or current malignancy",
            "criterions": [
                {
                    "exact_snippets": "prior or current malignancy",
                    "criterion": "malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. (Healthy volunteers ONLY - Part 1 and Part 4) known kidney disease",
            "criterions": [
                {
                    "exact_snippets": "known kidney disease",
                    "criterion": "kidney disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Pregnant or nursing participants",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing participants",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. History of allergic reactions to gadolinium-based MRI contrast agent",
            "criterions": [
                {
                    "exact_snippets": "History of allergic reactions to gadolinium-based MRI contrast agent",
                    "criterion": "allergic reactions to gadolinium-based MRI contrast agent",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. (Part 2, intracranial tumor patients ONLY) Other chemotherapy (besides what is being used to treat the intracranial tumor)",
            "criterions": [
                {
                    "exact_snippets": "Other chemotherapy (besides what is being used to treat the intracranial tumor)",
                    "criterion": "other chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. (Part 3, GBM patients ONLY) Has already begun therapy, prior to the first of two [18F]DASA-23 PET/MRI scans.",
            "criterions": [
                {
                    "exact_snippets": "Has already begun therapy",
                    "criterion": "therapy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "begun"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}