{
    "info": {
        "nct_id": "NCT03698162",
        "official_title": "Area B: Precise DCE-MRI Assessment of Brain Tumors",
        "inclusion_criteria": "* COHORT I: Recurrent high-grade glioma (often with thin areas of enhancement) treated with bevacizumab.\n* COHORT I: We will include adult patients with histopathologically confirmed high-grade glioma with evidence of tumor progression at baseline MRI who will undergo treatment with an anti-angiogenic agent (bevacizumab) with or without concomitant chemotherapy, and Karnofsky Performance Score > 60%.\n* COHORT I: At least 30 days should have elapsed since prior therapy including surgery and temozolomide chemoradiation.\n* COHORT I: Satisfactory renal, hepatic, and hematologic function is required.\n* COHORT II: Melanoma brain metastases (often small and spread throughout the brain) treated with immunotherapy.\n* COHORT II: We will include adult patients with a tissue-proven history of melanoma who have contrast enhancing brain masses who will undergo treatment with immunotherapy with an anti-CTLA-4 or anti-PD-1 approach (e.g. ipilimumab, pembrolizumab, or nivolumab), and Karnofsky Performance Score > 60%.\n* COHORT II: At least 30 days should have elapsed since prior therapy including surgery, stereotactic brain irradiation, and corticosteroid use.\nHealthy volunteers allowed\nMust have minimum age of 21 Years",
        "exclusion_criteria": "* COHORT I: Exclusion criteria include treatment with any other anti-cancer treatment, enzyme-inducing antiepileptic agents, anticoagulant treatment, pregnancy, other anti-angiogenesis therapy and prior thrombo-embolic disorders.\n* COHORT I: Exclusion criteria will include the standard contraindications for MRI: 1) prior work as a machinist or metal worker, or history of metal being removed from the eyes, 2) cardiac pacemaker or internal pacing wires, 3) non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or 4) claustrophobia, or uncontrollable motion disorder.\n* COHORT I: Pregnant women, prisoners, and institutionalized individuals will be excluded.\n* COHORT II: Exclusion criteria include treatment with any other anti-cancer treatment, and other immunotherapy exclusion criteria.\n* COHORT II: Non-cutaneous melanomas will be excluded.\n* COHORT II: Exclusion criteria will include the standard contraindications for MRI: 1) prior work as a machinist or metal worker, or history of metal being removed from the eyes, 2) cardiac pacemaker or internal pacing wires, 3) non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or 4) claustrophobia, or uncontrollable motion disorder.\n* COHORT II: Pregnant women, prisoners, and institutionalized individuals will be excluded.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* COHORT I: Recurrent high-grade glioma (often with thin areas of enhancement) treated with bevacizumab.",
            "criterions": [
                {
                    "exact_snippets": "Recurrent high-grade glioma",
                    "criterion": "high-grade glioma",
                    "requirements": [
                        {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with bevacizumab",
                    "criterion": "treatment with bevacizumab",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT I: We will include adult patients with histopathologically confirmed high-grade glioma with evidence of tumor progression at baseline MRI who will undergo treatment with an anti-angiogenic agent (bevacizumab) with or without concomitant chemotherapy, and Karnofsky Performance Score > 60%.",
            "criterions": [
                {
                    "exact_snippets": "adult patients",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age group",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "histopathologically confirmed high-grade glioma",
                    "criterion": "high-grade glioma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histopathological"
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of tumor progression at baseline MRI",
                    "criterion": "tumor progression",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "baseline MRI"
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky Performance Score > 60%",
                    "criterion": "Karnofsky Performance Score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT I: At least 30 days should have elapsed since prior therapy including surgery and temozolomide chemoradiation.",
            "criterions": [
                {
                    "exact_snippets": "At least 30 days should have elapsed since prior therapy including surgery and temozolomide chemoradiation.",
                    "criterion": "elapsed time since prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT I: Satisfactory renal, hepatic, and hematologic function is required.",
            "criterions": [
                {
                    "exact_snippets": "Satisfactory renal ... function is required.",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "satisfaction",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Satisfactory ... hepatic ... function is required.",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "satisfaction",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Satisfactory ... hematologic function is required.",
                    "criterion": "hematologic function",
                    "requirements": [
                        {
                            "requirement_type": "satisfaction",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT II: Melanoma brain metastases (often small and spread throughout the brain) treated with immunotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Melanoma brain metastases",
                    "criterion": "melanoma brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with immunotherapy",
                    "criterion": "treatment with immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT II: We will include adult patients with a tissue-proven history of melanoma who have contrast enhancing brain masses who will undergo treatment with immunotherapy with an anti-CTLA-4 or anti-PD-1 approach (e.g. ipilimumab, pembrolizumab, or nivolumab), and Karnofsky Performance Score > 60%.",
            "criterions": [
                {
                    "exact_snippets": "adult patients",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age group",
                            "expected_value": "adult"
                        }
                    ]
                },
                {
                    "exact_snippets": "tissue-proven history of melanoma",
                    "criterion": "melanoma",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "tissue-proven"
                        }
                    ]
                },
                {
                    "exact_snippets": "contrast enhancing brain masses",
                    "criterion": "brain masses",
                    "requirements": [
                        {
                            "requirement_type": "contrast enhancement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment with immunotherapy with an anti-CTLA-4 or anti-PD-1 approach",
                    "criterion": "immunotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "anti-CTLA-4",
                                "anti-PD-1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky Performance Score > 60%",
                    "criterion": "Karnofsky Performance Score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT II: At least 30 days should have elapsed since prior therapy including surgery, stereotactic brain irradiation, and corticosteroid use.",
            "criterions": [
                {
                    "exact_snippets": "At least 30 days should have elapsed since prior therapy including surgery",
                    "criterion": "elapsed time since prior surgery",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 30 days should have elapsed since prior therapy including ... stereotactic brain irradiation",
                    "criterion": "elapsed time since prior stereotactic brain irradiation",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "At least 30 days should have elapsed since prior therapy including ... corticosteroid use",
                    "criterion": "elapsed time since prior corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "time elapsed",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 21 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 21 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 21,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* COHORT I: Exclusion criteria include treatment with any other anti-cancer treatment, enzyme-inducing antiepileptic agents, anticoagulant treatment, pregnancy, other anti-angiogenesis therapy and prior thrombo-embolic disorders.",
            "criterions": [
                {
                    "exact_snippets": "treatment with any other anti-cancer treatment",
                    "criterion": "anti-cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "enzyme-inducing antiepileptic agents",
                    "criterion": "enzyme-inducing antiepileptic agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "anticoagulant treatment",
                    "criterion": "anticoagulant treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other anti-angiogenesis therapy",
                    "criterion": "anti-angiogenesis therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "prior thrombo-embolic disorders",
                    "criterion": "thrombo-embolic disorders",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT I: Exclusion criteria will include the standard contraindications for MRI: 1) prior work as a machinist or metal worker, or history of metal being removed from the eyes, 2) cardiac pacemaker or internal pacing wires, 3) non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or 4) claustrophobia, or uncontrollable motion disorder.",
            "criterions": [
                {
                    "exact_snippets": "prior work as a machinist or metal worker",
                    "criterion": "occupation history",
                    "requirements": [
                        {
                            "requirement_type": "occupation",
                            "expected_value": [
                                "machinist",
                                "metal worker"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "history of metal being removed from the eyes",
                    "criterion": "history of metal removal from eyes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac pacemaker or internal pacing wires",
                    "criterion": "cardiac pacemaker or internal pacing wires",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-MRI compatible vena cava filter",
                    "criterion": "non-MRI compatible vena cava filter",
                    "requirements": [
                        {
                            "requirement_type": "compatibility",
                            "expected_value": "non-MRI compatible"
                        }
                    ]
                },
                {
                    "exact_snippets": "vascular aneurysm clip",
                    "criterion": "vascular aneurysm clip",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart valve",
                    "criterion": "heart valve",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal or ventricular shunt",
                    "criterion": "spinal or ventricular shunt",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "optic implant",
                    "criterion": "optic implant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "neuro-stimulator unit",
                    "criterion": "neuro-stimulator unit",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ocular implant",
                    "criterion": "ocular implant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intrauterine device",
                    "criterion": "intrauterine device",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable motion disorder",
                    "criterion": "uncontrollable motion disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT I: Pregnant women, prisoners, and institutionalized individuals will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women ... will be excluded.",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "prisoners ... will be excluded.",
                    "criterion": "prisoner status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "institutionalized individuals will be excluded.",
                    "criterion": "institutionalization",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT II: Exclusion criteria include treatment with any other anti-cancer treatment, and other immunotherapy exclusion criteria.",
            "criterions": [
                {
                    "exact_snippets": "treatment with any other anti-cancer treatment",
                    "criterion": "anti-cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other immunotherapy exclusion criteria",
                    "criterion": "immunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT II: Non-cutaneous melanomas will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "Non-cutaneous melanomas will be excluded.",
                    "criterion": "non-cutaneous melanomas",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT II: Exclusion criteria will include the standard contraindications for MRI: 1) prior work as a machinist or metal worker, or history of metal being removed from the eyes, 2) cardiac pacemaker or internal pacing wires, 3) non-MRI compatible vena cava filter, vascular aneurysm clip, heart valve, spinal or ventricular shunt, optic implant, neuro-stimulator unit, ocular implant, or intrauterine device, or 4) claustrophobia, or uncontrollable motion disorder.",
            "criterions": [
                {
                    "exact_snippets": "prior work as a machinist or metal worker",
                    "criterion": "occupation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": "machinist or metal worker"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of metal being removed from the eyes",
                    "criterion": "metal removal from eyes",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac pacemaker or internal pacing wires",
                    "criterion": "cardiac pacemaker or internal pacing wires",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-MRI compatible vena cava filter",
                    "criterion": "vena cava filter",
                    "requirements": [
                        {
                            "requirement_type": "compatibility",
                            "expected_value": "non-MRI compatible"
                        }
                    ]
                },
                {
                    "exact_snippets": "vascular aneurysm clip",
                    "criterion": "vascular aneurysm clip",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "heart valve",
                    "criterion": "heart valve",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spinal or ventricular shunt",
                    "criterion": "spinal or ventricular shunt",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "optic implant",
                    "criterion": "optic implant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "neuro-stimulator unit",
                    "criterion": "neuro-stimulator unit",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ocular implant",
                    "criterion": "ocular implant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intrauterine device",
                    "criterion": "intrauterine device",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "claustrophobia",
                    "criterion": "claustrophobia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrollable motion disorder",
                    "criterion": "uncontrollable motion disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* COHORT II: Pregnant women, prisoners, and institutionalized individuals will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant women ... will be excluded.",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "prisoners ... will be excluded.",
                    "criterion": "prisoner status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "institutionalized individuals will be excluded.",
                    "criterion": "institutionalization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}