{
"info": {
"nct_id": "NCT04095091",
"official_title": "Real-time Tumor Localization and Guidance for Radiotherapy Using Ultrasound (US) and Magnetic Resonance (MR)",
"inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "",
"miscellaneous_criteria": "Inclusion Criteria (Healthy Volunteers):\n\n* Must be eighteen (18) years of age or older.\n* Must be able to provide informed consent.\n\nInclusion Criteria (Patients):\n\n* Patients diagnosed with malignancies of the liver.\n\nExclusion Criteria (All):\n\n* Under the age of eighteen (18) years.\n* BMI exceeds the size of the bore of the MRI scanner.\n* Unable or unwilling to provide informed consent.\n* Contraindications, as described in the volunteer consent form, to MR or US scanning such as but not limited to accidental or implanted ferrous metal and/or implanted devices whose function can be disturbed by the main magnetic field, gradient magnetic fields, or radiofrequency energy.\n* Women who are pregnant, suspect they might be pregnant or breastfeeding."
},
"inclusion_lines": [
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [],
"miscellaneous_lines": [
{
"line": "Inclusion Criteria (Healthy Volunteers):",
"criterions": [
{
"exact_snippets": "Healthy Volunteers",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "* Must be eighteen (18) years of age or older.",
"criterions": [
{
"exact_snippets": "eighteen (18) years of age or older",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Must be able to provide informed consent.",
"criterions": [
{
"exact_snippets": "Must be able to provide informed consent.",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
}
]
},
{
"line": "* Patients diagnosed with malignancies of the liver.",
"criterions": [
{
"exact_snippets": "malignancies of the liver",
"criterion": "liver malignancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Under the age of eighteen (18) years.",
"criterions": [
{
"exact_snippets": "Under the age of eighteen (18) years.",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 18,
"unit": "years"
}
}
]
}
]
},
{
"line": "* BMI exceeds the size of the bore of the MRI scanner.",
"criterions": [
{
"exact_snippets": "BMI exceeds the size of the bore of the MRI scanner.",
"criterion": "BMI",
"requirements": [
{
"requirement_type": "comparison",
"expected_value": "exceeds the size of the bore of the MRI scanner"
}
]
}
]
},
{
"line": "* Unable or unwilling to provide informed consent.",
"criterions": [
{
"exact_snippets": "Unable ... to provide informed consent.",
"criterion": "ability to provide informed consent",
"requirements": [
{
"requirement_type": "ability",
"expected_value": true
}
]
},
{
"exact_snippets": "unwilling to provide informed consent.",
"criterion": "willingness to provide informed consent",
"requirements": [
{
"requirement_type": "willingness",
"expected_value": true
}
]
}
]
},
{
"line": "* Contraindications, as described in the volunteer consent form, to MR or US scanning such as but not limited to accidental or implanted ferrous metal and/or implanted devices whose function can be disturbed by the main magnetic field, gradient magnetic fields, or radiofrequency energy.",
"criterions": [
{
"exact_snippets": "Contraindications, as described in the volunteer consent form, to MR or US scanning",
"criterion": "contraindications to MR or US scanning",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "accidental or implanted ferrous metal",
"criterion": "accidental or implanted ferrous metal",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "implanted devices whose function can be disturbed by the main magnetic field, gradient magnetic fields, or radiofrequency energy",
"criterion": "implanted devices affected by magnetic fields or radiofrequency energy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Women who are pregnant, suspect they might be pregnant or breastfeeding.",
"criterions": [
{
"exact_snippets": "Women who are pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "suspect they might be pregnant",
"criterion": "suspected pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
}
],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": [
{
"line": "Inclusion Criteria (Patients):",
"criterions": []
},
{
"line": "Exclusion Criteria (All):",
"criterions": []
}
]
}