{
    "info": {
        "nct_id": "NCT02582931",
        "official_title": "Pilot Study of MRI-Guided Stereotactic Body Radiation Therapy (SBRT) for Ovarian Cancer",
        "inclusion_criteria": "* Histologically or cytologically confirmed primary disease histology of solid ovarian, fallopian tube, or primary peritoneal tumor categorization.\n* Deemed medically fit for stereotactic body radiation therapy by the treating physician.\n* At least 18 years old.\n* Karnofsky Performance Status ≥ 70\n* Completed any systemic therapy (excluding endocrine therapy, which may be ongoing) at least one week prior to planned start of SBRT (two weeks preferred) and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred).\n* Able to understand and be willing to sign an IRB approved written informed consent document (or legally authorized representative, if applicable).\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, gated, and/or online adaptive SBRT\n* Current central nervous systemic disease.\n* Widespread progressive disease, i.e., more than three sites of progressive disease (note that more than three sites of disease are permitted provided there are no more than three sites of progressive disease).\n* Actively receiving any investigational agents.\n* Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.\n* Medical contraindication to undergoing MR imaging.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Histologically or cytologically confirmed primary disease histology of solid ovarian, fallopian tube, or primary peritoneal tumor categorization.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed primary disease histology",
                    "criterion": "primary disease histology",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "solid ovarian, fallopian tube, or primary peritoneal tumor categorization",
                    "criterion": "tumor categorization",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "solid ovarian",
                                "fallopian tube",
                                "primary peritoneal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Deemed medically fit for stereotactic body radiation therapy by the treating physician.",
            "criterions": [
                {
                    "exact_snippets": "Deemed medically fit for stereotactic body radiation therapy",
                    "criterion": "medical fitness for stereotactic body radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "deemed fit by treating physician"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At least 18 years old.",
            "criterions": [
                {
                    "exact_snippets": "At least 18 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky Performance Status ≥ 70",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Status ≥ 70",
                    "criterion": "Karnofsky Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Completed any systemic therapy (excluding endocrine therapy, which may be ongoing) at least one week prior to planned start of SBRT (two weeks preferred) and must have no plans to initiate systemic therapy for at least one week following end of SBRT (two weeks preferred).",
            "criterions": [
                {
                    "exact_snippets": "Completed any systemic therapy (excluding endocrine therapy, which may be ongoing)",
                    "criterion": "systemic therapy completion",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one week prior to planned start of SBRT",
                    "criterion": "time since systemic therapy completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must have no plans to initiate systemic therapy for at least one week following end of SBRT",
                    "criterion": "plans to initiate systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "initiation plans",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time after SBRT",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to understand and be willing to sign an IRB approved written informed consent document (or legally authorized representative, if applicable).",
            "criterions": [
                {
                    "exact_snippets": "Able to understand",
                    "criterion": "understanding ability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to sign",
                    "criterion": "willingness to sign consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "IRB approved written informed consent document",
                    "criterion": "IRB approved written informed consent document",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, gated, and/or online adaptive SBRT",
            "criterions": [
                {
                    "exact_snippets": "Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated",
                    "criterion": "past history of radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "within the projected treatment field of any of the disease sites to be treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current central nervous systemic disease.",
            "criterions": [
                {
                    "exact_snippets": "Current central nervous systemic disease.",
                    "criterion": "central nervous systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Widespread progressive disease, i.e., more than three sites of progressive disease (note that more than three sites of disease are permitted provided there are no more than three sites of progressive disease).",
            "criterions": [
                {
                    "exact_snippets": "Widespread progressive disease",
                    "criterion": "progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "more than three sites of progressive disease",
                    "criterion": "sites of progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "sites"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Actively receiving any investigational agents.",
            "criterions": [
                {
                    "exact_snippets": "Actively receiving any investigational agents",
                    "criterion": "investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Presence of uncontrolled intercurrent illness including, but not limited to, ongoing or active infection",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of uncontrolled intercurrent illness including, but not limited to, ... symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of uncontrolled intercurrent illness including, but not limited to, ... unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of uncontrolled intercurrent illness including, but not limited to, ... cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of uncontrolled intercurrent illness including, but not limited to, ... psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit compliance with study requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant and/or breastfeeding. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 14 days of study entry"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medical contraindication to undergoing MR imaging.",
            "criterions": [
                {
                    "exact_snippets": "Medical contraindication to undergoing MR imaging.",
                    "criterion": "MR imaging",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}