{
    "info": {
        "nct_id": "NCT01757717",
        "official_title": "A Pilot Study of Image-Guided Navigation for High Dose Rate Temporary Interstitial Brachytherapy in the Palliative Management of Previously Treated Tumors of the Spine and Pelvis",
        "inclusion_criteria": "* Patients must have histologic proof of a malignancy suitable for radiation therapy.\n* Patients must have received prior external beam radiation therapy to the region proposed for HDR brachytherapy treatment; evaluation of doses previously delivered to spinal cord/cauda equine, pelvis, and other critical structures (bowel, kidneys, rectum) will be taken into consideration.\n* If repeat irradiation would exceed any normal tissue constraint set by MSKCC Radiation Oncology Department dose constraint criteria, the patient will potentially be eligible.\n* If the total prior radiation dose to the cord or pelvis exceeds 100 Gy BED equivalent, the patient will be potentially eligible, where a total of 100 BED Gy equivalent is determined by the biological equivalent dose (BED) calculation; BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord late effect and equals 2. [Rades 2005, Nieder 2005, Sahgal 2012]\n* KPS ≥ 60\n* Age ≥ 18 years old\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patients who may receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by MSKCC Radiation Oncology Department dose constraint criteria.\n* Patients with kyphoplasty cement or hardware that would preclude effective catheter placement.\n* Patients with paraspinal extension of disease with visceral involvement.\n* Abnormal complete blood count. Any of the following:\n* Platelet count < 75,000/ml\n* Hb level < 9gm/dl\n* WBC < 3.5/ml\n* Abnormal coagulation profile: INR > 2.5 and/or PTT > 80\n* Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded.\n* Contraindications to general anesthesia",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have histologic proof of a malignancy suitable for radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "histologic proof of a malignancy"
                    ],
                    "criterion": "malignancy",
                    "requirement_type": "histologic proof",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "suitable for radiation therapy"
                    ],
                    "criterion": "malignancy",
                    "requirement_type": "suitability for radiation therapy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients must have received prior external beam radiation therapy to the region proposed for HDR brachytherapy treatment; evaluation of doses previously delivered to spinal cord/cauda equine, pelvis, and other critical structures (bowel, kidneys, rectum) will be taken into consideration.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients must have received prior external beam radiation therapy"
                    ],
                    "criterion": "external beam radiation therapy",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "evaluation of doses previously delivered to spinal cord/cauda equine"
                    ],
                    "criterion": "doses previously delivered to spinal cord/cauda equine",
                    "requirement_type": "evaluation",
                    "expected_value": "consideration"
                },
                {
                    "exact_snippets": [
                        "evaluation of doses previously delivered to",
                        "pelvis"
                    ],
                    "criterion": "doses previously delivered to pelvis",
                    "requirement_type": "evaluation",
                    "expected_value": "consideration"
                },
                {
                    "exact_snippets": [
                        "evaluation of doses previously delivered to",
                        "other critical structures (bowel, kidneys, rectum)"
                    ],
                    "criterion": "doses previously delivered to other critical structures",
                    "requirement_type": "evaluation",
                    "expected_value": "consideration"
                }
            ]
        },
        {
            "line": "* If repeat irradiation would exceed any normal tissue constraint set by MSKCC Radiation Oncology Department dose constraint criteria, the patient will potentially be eligible.",
            "criterions": [
                {
                    "exact_snippets": [
                        "repeat irradiation would exceed any normal tissue constraint"
                    ],
                    "criterion": "normal tissue constraint",
                    "requirement_type": "exceedance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "set by MSKCC Radiation Oncology Department dose constraint criteria"
                    ],
                    "criterion": "dose constraint criteria",
                    "requirement_type": "source",
                    "expected_value": "MSKCC Radiation Oncology Department"
                }
            ]
        },
        {
            "line": "* If the total prior radiation dose to the cord or pelvis exceeds 100 Gy BED equivalent, the patient will be potentially eligible, where a total of 100 BED Gy equivalent is determined by the biological equivalent dose (BED) calculation; BED = nd(1 + d/α/β), where n = number of fractions and d = dose per fraction; α/β is the constant for spinal cord late effect and equals 2. [Rades 2005, Nieder 2005, Sahgal 2012]",
            "criterions": [
                {
                    "exact_snippets": [
                        "total prior radiation dose to the cord or pelvis"
                    ],
                    "criterion": "prior radiation dose",
                    "requirement_type": "location",
                    "expected_value": [
                        "cord",
                        "pelvis"
                    ]
                },
                {
                    "exact_snippets": [
                        "total prior radiation dose to the cord or pelvis exceeds 100 Gy BED equivalent"
                    ],
                    "criterion": "prior radiation dose",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 100
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* KPS ≥ 60",
            "criterions": [
                {
                    "exact_snippets": [
                        "KPS ≥ 60"
                    ],
                    "criterion": "Karnofsky Performance Status (KPS)",
                    "requirement_type": "minimum value",
                    "expected_value": {
                        "operator": ">=",
                        "value": 60
                    }
                }
            ]
        },
        {
            "line": "* Age ≥ 18 years old",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age ≥ 18 years old"
                    ],
                    "criterion": "age",
                    "requirement_type": "N/A",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients who may receive therapeutically effective doses via an external beam approach to the lesion of interest as specified by MSKCC Radiation Oncology Department dose constraint criteria.",
            "criterions": [
                {
                    "exact_snippets": [
                        "therapeutically effective doses"
                    ],
                    "criterion": "dose",
                    "requirement_type": "effectiveness",
                    "expected_value": "therapeutically effective"
                },
                {
                    "exact_snippets": [
                        "external beam approach"
                    ],
                    "criterion": "treatment approach",
                    "requirement_type": "type",
                    "expected_value": "external beam"
                },
                {
                    "exact_snippets": [
                        "lesion of interest"
                    ],
                    "criterion": "lesion",
                    "requirement_type": "interest",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "MSKCC Radiation Oncology Department dose constraint criteria"
                    ],
                    "criterion": "dose constraint criteria",
                    "requirement_type": "source",
                    "expected_value": "MSKCC Radiation Oncology Department"
                }
            ]
        },
        {
            "line": "* Patients with kyphoplasty cement or hardware that would preclude effective catheter placement.",
            "criterions": [
                {
                    "exact_snippets": [
                        "kyphoplasty cement"
                    ],
                    "criterion": "kyphoplasty cement",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "hardware that would preclude effective catheter placement"
                    ],
                    "criterion": "hardware",
                    "requirement_type": "impact on catheter placement",
                    "expected_value": "preclude effective placement"
                }
            ]
        },
        {
            "line": "* Patients with paraspinal extension of disease with visceral involvement.",
            "criterions": [
                {
                    "exact_snippets": [
                        "paraspinal extension of disease"
                    ],
                    "criterion": "paraspinal extension",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "visceral involvement"
                    ],
                    "criterion": "visceral involvement",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Abnormal complete blood count. Any of the following:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Abnormal complete blood count"
                    ],
                    "criterion": "complete blood count",
                    "requirement_type": "normality",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Platelet count < 75,000/ml",
            "criterions": [
                {
                    "exact_snippets": [
                        "Platelet count < 75,000/ml"
                    ],
                    "criterion": "platelet",
                    "requirement_type": "count",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 75000
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Hb level < 9gm/dl",
            "criterions": [
                {
                    "exact_snippets": [
                        "Hb level < 9gm/dl"
                    ],
                    "criterion": "Hb level",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 9
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* WBC < 3.5/ml",
            "criterions": [
                {
                    "exact_snippets": [
                        "WBC < 3.5/ml"
                    ],
                    "criterion": "white blood cell",
                    "requirement_type": "count",
                    "expected_value": {
                        "operator": "<",
                        "value": 3.5
                    }
                }
            ]
        },
        {
            "line": "* Abnormal coagulation profile: INR > 2.5 and/or PTT > 80",
            "criterions": [
                {
                    "exact_snippets": [
                        "Abnormal coagulation profile",
                        "INR > 2.5"
                    ],
                    "criterion": "INR",
                    "requirement_type": "value",
                    "expected_value": {
                        "operator": ">",
                        "value": 2.5
                    }
                },
                {
                    "exact_snippets": [
                        "Abnormal coagulation profile",
                        "PTT > 80"
                    ],
                    "criterion": "PTT",
                    "requirement_type": "value",
                    "expected_value": {
                        "operator": ">",
                        "value": 80
                    }
                }
            ]
        },
        {
            "line": "* Patients who are on anticoagulation medication that may not be safely held for the procedure (≥ 5 days for antiplatelet agents and warfarin; ≥ 24 hours for low-molecular weight heparin formulations) will be excluded.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients who are on anticoagulation medication"
                    ],
                    "criterion": "anticoagulation medication",
                    "requirement_type": "usage",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "may not be safely held for the procedure"
                    ],
                    "criterion": "anticoagulation medication",
                    "requirement_type": "safety of holding",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "≥ 5 days for antiplatelet agents"
                    ],
                    "criterion": "antiplatelet agents",
                    "requirement_type": "holding duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "≥ 5 days for",
                        "warfarin"
                    ],
                    "criterion": "warfarin",
                    "requirement_type": "holding duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "≥ 24 hours for low-molecular weight heparin formulations"
                    ],
                    "criterion": "low-molecular weight heparin formulations",
                    "requirement_type": "holding duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 24
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Contraindications to general anesthesia",
            "criterions": [
                {
                    "exact_snippets": [
                        "Contraindications to general anesthesia"
                    ],
                    "criterion": "general anesthesia",
                    "requirement_type": "contraindications",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}