{
    "info": {
        "nct_id": "NCT00787982",
        "official_title": "Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors",
        "inclusion_criteria": "* Patient or family able and willing to give informed consent.\n* Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy).\n* Three or fewer previously treated or untreated lesion(s) in the brain.\n* Tumor size ≤ 3.0 cm in largest diameter.\n* MR imaging is not contraindicated for the patient.\n* Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.\n* Able and willing to attend all study visits.\n* Karnofsky Performance Scale score >70 for patients over the age of 15.\n* Lansky Play Scale >70 for patients 15 years of age or younger.\nHealthy volunteers allowed",
        "exclusion_criteria": "* Patients or family unwilling or unable to give written consent.\n* Patients who cannot physically fit in, or are too heavy for, the MRI scanner.\n* Patients with contra-indications to MRI imaging, such as, but not limited to, pacemakers or defibrillators, non-compatible aneurysm clips, shrapnel, or other internal ferromagnetic objects.\n* Known sensitivity to gadolinium-DTPA.\n* Based on Treatment Planning Imaging (MR and/or CT):\n\n  * Brain edema and/or mass effect that causes midline shift or shift in wall of ventricle of more than 5 mm.\n  * Lesions localized in the brain stem.\n  * Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves.\n  * Evidence of recent (<2 weeks) hemorrhage.\n* Presence of more than 3 brain tumors at the time of enrollment.\n* Symptoms and signs of increased intracranial pressure.\n* Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).\n* Patients who are unable to receive corticosteroids.\n* Positive pregnancy test for women of child-bearing age.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patient or family able and willing to give informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Patient or family able and willing to give informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy).",
            "criterions": [
                {
                    "exact_snippets": "metastatic cancer to the brain",
                    "criterion": "metastatic brain cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy)",
                    "criterion": "conventional therapy failure",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "therapy"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Three or fewer previously treated or untreated lesion(s) in the brain.",
            "criterions": [
                {
                    "exact_snippets": "Three or fewer previously treated or untreated lesion(s) in the brain.",
                    "criterion": "brain lesions",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "lesions"
                            }
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": [
                                "previously treated",
                                "untreated"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tumor size ≤ 3.0 cm in largest diameter.",
            "criterions": [
                {
                    "exact_snippets": "Tumor size ≤ 3.0 cm in largest diameter.",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* MR imaging is not contraindicated for the patient.",
            "criterions": [
                {
                    "exact_snippets": "MR imaging is not contraindicated",
                    "criterion": "MR imaging",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.",
            "criterions": [
                {
                    "exact_snippets": "Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans",
                    "criterion": "lesion definition on MRI",
                    "requirements": [
                        {
                            "requirement_type": "clarity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "as determined by the treating surgeon",
                    "criterion": "determination by treating surgeon",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "treating surgeon"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able and willing to attend all study visits.",
            "criterions": [
                {
                    "exact_snippets": "Able and willing to attend all study visits.",
                    "criterion": "attendance at study visits",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky Performance Scale score >70 for patients over the age of 15.",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Scale score >70",
                    "criterion": "Karnofsky Performance Scale score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients over the age of 15",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 15,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lansky Play Scale >70 for patients 15 years of age or younger.",
            "criterions": [
                {
                    "exact_snippets": "Lansky Play Scale >70",
                    "criterion": "Lansky Play Scale",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients 15 years of age or younger",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 15,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients or family unwilling or unable to give written consent.",
            "criterions": [
                {
                    "exact_snippets": "Patients or family unwilling ... to give written consent.",
                    "criterion": "written consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients or family ... unable to give written consent.",
                    "criterion": "written consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who cannot physically fit in, or are too heavy for, the MRI scanner.",
            "criterions": [
                {
                    "exact_snippets": "cannot physically fit in ... MRI scanner",
                    "criterion": "physical fit in MRI scanner",
                    "requirements": [
                        {
                            "requirement_type": "fit",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "too heavy for ... MRI scanner",
                    "criterion": "weight for MRI scanner",
                    "requirements": [
                        {
                            "requirement_type": "weight",
                            "expected_value": {
                                "operator": "<=",
                                "value": 350,
                                "unit": "lbs"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with contra-indications to MRI imaging, such as, but not limited to, pacemakers or defibrillators, non-compatible aneurysm clips, shrapnel, or other internal ferromagnetic objects.",
            "criterions": [
                {
                    "exact_snippets": "contra-indications to MRI imaging",
                    "criterion": "contra-indications to MRI imaging",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "pacemakers",
                    "criterion": "pacemakers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "defibrillators",
                    "criterion": "defibrillators",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "non-compatible aneurysm clips",
                    "criterion": "non-compatible aneurysm clips",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "shrapnel",
                    "criterion": "shrapnel",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other internal ferromagnetic objects",
                    "criterion": "internal ferromagnetic objects",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known sensitivity to gadolinium-DTPA.",
            "criterions": [
                {
                    "exact_snippets": "Known sensitivity to gadolinium-DTPA.",
                    "criterion": "sensitivity to gadolinium-DTPA",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Based on Treatment Planning Imaging (MR and/or CT):",
            "criterions": [
                {
                    "exact_snippets": "Based on Treatment Planning Imaging (MR and/or CT)",
                    "criterion": "treatment planning imaging",
                    "requirements": [
                        {
                            "requirement_type": "modality",
                            "expected_value": [
                                "MR",
                                "CT"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Brain edema and/or mass effect that causes midline shift or shift in wall of ventricle of more than 5 mm.",
            "criterions": [
                {
                    "exact_snippets": "Brain edema",
                    "criterion": "brain edema",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mass effect",
                    "criterion": "mass effect",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "midline shift ... more than 5 mm",
                    "criterion": "midline shift",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "shift in wall of ventricle ... more than 5 mm",
                    "criterion": "shift in wall of ventricle",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lesions localized in the brain stem.",
            "criterions": [
                {
                    "exact_snippets": "Lesions localized in the brain stem",
                    "criterion": "lesions",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "brain stem"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves.",
            "criterions": [
                {
                    "exact_snippets": "Lesions less than 5mm from primary branches of cerebral vessels",
                    "criterion": "lesion proximity to cerebral vessels",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Lesions less than 5mm from ... venous sinus",
                    "criterion": "lesion proximity to venous sinus",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Lesions less than 5mm from ... hypophysis",
                    "criterion": "lesion proximity to hypophysis",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Lesions less than 5mm from ... cranial nerves",
                    "criterion": "lesion proximity to cranial nerves",
                    "requirements": [
                        {
                            "requirement_type": "distance",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "mm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of recent (<2 weeks) hemorrhage.",
            "criterions": [
                {
                    "exact_snippets": "Evidence of recent (<2 weeks) hemorrhage.",
                    "criterion": "hemorrhage",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Presence of more than 3 brain tumors at the time of enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Presence of more than 3 brain tumors",
                    "criterion": "brain tumors",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Symptoms and signs of increased intracranial pressure.",
            "criterions": [
                {
                    "exact_snippets": "Symptoms and signs of increased intracranial pressure",
                    "criterion": "increased intracranial pressure",
                    "requirements": [
                        {
                            "requirement_type": "symptoms and signs",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).",
            "criterions": [
                {
                    "exact_snippets": "Medical issues which prohibit the patient from undergoing surgery",
                    "criterion": "medical issues prohibiting surgery",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who are unable to receive corticosteroids.",
            "criterions": [
                {
                    "exact_snippets": "unable to receive corticosteroids",
                    "criterion": "corticosteroid administration",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive pregnancy test for women of child-bearing age.",
            "criterions": [
                {
                    "exact_snippets": "Positive pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of child-bearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "child-bearing age"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}