{
"info": {
"nct_id": "NCT01291082",
"official_title": "Whole-body Magnetische Resonantie Voor Het Opsporen Van Bot- en Weke Delenmetastasen Bij patiënten Met Een Borstcarcinoom (MetaMaRBo)",
"inclusion_criteria": "1. Patients with a proven breast cancer (by biopsy or imaging)\n2. Bone metastases proven by MR, PET-CT or Bone. Patients with visceral metastases can be included if bone metastases are also present.\n3. Patient with an informed consent.\nHealthy volunteers allowed\nMust have minimum age of 20 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "1. Patients with a single bone metastasis treated by Radiotherapy will be excluded.\n2. Patients with contra-indication for MRI: pacemaker, cochlear implant, non MR compatible devices (Baclofenpump).\n3. Claustrophobia\n4. Patient in a bad general condition.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Patients with a proven breast cancer (by biopsy or imaging)",
"criterions": [
{
"exact_snippets": "proven breast cancer (by biopsy or imaging)",
"criterion": "breast cancer",
"requirements": [
{
"requirement_type": "diagnosis method",
"expected_value": [
"biopsy",
"imaging"
]
}
]
}
]
},
{
"line": "2. Bone metastases proven by MR, PET-CT or Bone. Patients with visceral metastases can be included if bone metastases are also present.",
"criterions": [
{
"exact_snippets": "Bone metastases proven by MR, PET-CT or Bone.",
"criterion": "bone metastases",
"requirements": [
{
"requirement_type": "proof method",
"expected_value": [
"MR",
"PET-CT",
"Bone"
]
}
]
},
{
"exact_snippets": "Patients with visceral metastases can be included if bone metastases are also present.",
"criterion": "visceral metastases",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "3. Patient with an informed consent.",
"criterions": [
{
"exact_snippets": "informed consent",
"criterion": "informed consent",
"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 have minimum age of 20 Years",
"criterions": [
{
"exact_snippets": "minimum age of 20 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 80 Years",
"criterions": [
{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 80,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. Patients with a single bone metastasis treated by Radiotherapy will be excluded.",
"criterions": [
{
"exact_snippets": "single bone metastasis",
"criterion": "bone metastasis",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": "single"
}
]
},
{
"exact_snippets": "treated by Radiotherapy",
"criterion": "treatment",
"requirements": [
{
"requirement_type": "type",
"expected_value": "Radiotherapy"
}
]
}
]
},
{
"line": "2. Patients with contra-indication for MRI: pacemaker, cochlear implant, non MR compatible devices (Baclofenpump).",
"criterions": [
{
"exact_snippets": "contra-indication for MRI: pacemaker",
"criterion": "contra-indication for MRI",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "pacemaker"
}
]
},
{
"exact_snippets": "contra-indication for MRI: ... cochlear implant",
"criterion": "contra-indication for MRI",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "cochlear implant"
}
]
},
{
"exact_snippets": "contra-indication for MRI: ... non MR compatible devices (Baclofenpump)",
"criterion": "contra-indication for MRI",
"requirements": [
{
"requirement_type": "presence",
"expected_value": "non MR compatible devices (Baclofenpump)"
}
]
}
]
},
{
"line": "3. Claustrophobia",
"criterions": [
{
"exact_snippets": "Claustrophobia",
"criterion": "claustrophobia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "4. Patient in a bad general condition.",
"criterions": [
{
"exact_snippets": "Patient in a bad general condition",
"criterion": "general condition",
"requirements": [
{
"requirement_type": "quality",
"expected_value": "bad"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}