{
"info": {
"nct_id": "NCT01190566",
"official_title": "PET-MR Fusion Imaging and Surrogate Marker for Prediction and Monitoring of Response to Neoadjuvant Chemotherapy in Breast Cancer Patients",
"inclusion_criteria": "* Pathologically confirmed breast cancer\n* Clinical stage IIb, IIIa, IIIb, IIIc\n* Must have measurable disease\n* Performance status of ECOG 0-2\n* Adequate, bone marrow, liver, heart, and renal function\n* Who did not receive chemotherapy for breast cancer\n* Must agree with and signed informed consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
"exclusion_criteria": "* Prior history of cancer besides breast cancer\n* Active bacterial infection\n* Pregnant or lactating women\n* Psychological disease or seizure\n* History of arrhythmia, congestive heart failure, myocardial infarct, or unstable angina\n* Male breast cancer\n* Who had a pacemaker or history of open heart surgery",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Pathologically confirmed breast cancer",
"criterions": [
{
"exact_snippets": "Pathologically confirmed breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "pathologically confirmed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Pathologically confirmed breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "pathologically confirmed"
}
}
]
}
},
{
"identified_line": {
"line": "* Clinical stage IIb, IIIa, IIIb, IIIc",
"criterions": [
{
"exact_snippets": "Clinical stage IIb, IIIa, IIIb, IIIc",
"criterion": "clinical stage",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"IIb",
"IIIa",
"IIIb",
"IIIc"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Clinical stage IIb, IIIa, IIIb, IIIc",
"criterion": "clinical stage",
"requirement": {
"requirement_type": "presence",
"expected_value": [
"IIb",
"IIIa",
"IIIb",
"IIIc"
]
}
}
]
}
},
{
"identified_line": {
"line": "* Must have measurable disease",
"criterions": [
{
"exact_snippets": "Must have measurable disease",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must have measurable disease",
"criterion": "measurable disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Performance status of ECOG 0-2",
"criterions": [
{
"exact_snippets": "Performance status of ECOG 0-2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Performance status of ECOG 0-2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate, bone marrow, liver, heart, and renal function",
"criterions": [
{
"exact_snippets": "Adequate, bone marrow",
"criterion": "bone marrow function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate, ... liver",
"criterion": "liver function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate, ... heart",
"criterion": "heart function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate, ... renal function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate, bone marrow",
"criterion": "bone marrow function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate, ... liver",
"criterion": "liver function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate, ... heart",
"criterion": "heart function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "Adequate, ... renal function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Who did not receive chemotherapy for breast cancer",
"criterions": [
{
"exact_snippets": "did not receive chemotherapy for breast cancer",
"criterion": "chemotherapy for breast cancer",
"requirement": {
"requirement_type": "receipt",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "did not receive chemotherapy for breast cancer",
"criterion": "chemotherapy for breast cancer",
"requirement": {
"requirement_type": "receipt",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Must agree with and signed informed consent",
"criterions": [
{
"exact_snippets": "Must agree with and signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "Must agree with and signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signature",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must agree with and signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "Must agree with and signed informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "signature",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 70 Years",
"criterions": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 70 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 70,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Prior history of cancer besides breast cancer",
"criterions": [
{
"exact_snippets": "Prior history of cancer besides breast cancer",
"criterion": "prior history of cancer",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "breast cancer"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Prior history of cancer besides breast cancer",
"criterion": "prior history of cancer",
"requirement": {
"requirement_type": "exclusion",
"expected_value": "breast cancer"
}
}
}
},
{
"identified_line": {
"line": "* Active bacterial infection",
"criterions": [
{
"exact_snippets": "Active bacterial infection",
"criterion": "bacterial infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Active bacterial infection",
"criterion": "bacterial infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Pregnant or lactating women",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating women",
"criterion": "lactation status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating women",
"criterion": "lactation status",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Psychological disease or seizure",
"criterions": [
{
"exact_snippets": "Psychological disease",
"criterion": "psychological disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "seizure",
"criterion": "seizure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Psychological disease",
"criterion": "psychological disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "seizure",
"criterion": "seizure",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* History of arrhythmia, congestive heart failure, myocardial infarct, or unstable angina",
"criterions": [
{
"exact_snippets": "History of arrhythmia",
"criterion": "arrhythmia",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... myocardial infarct",
"criterion": "myocardial infarct",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... unstable angina",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of arrhythmia",
"criterion": "arrhythmia",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... myocardial infarct",
"criterion": "myocardial infarct",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "History of ... unstable angina",
"criterion": "unstable angina",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Male breast cancer",
"criterions": [
{
"exact_snippets": "Male breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "gender",
"expected_value": "male"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Male breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "gender",
"expected_value": "male"
}
}
}
},
{
"identified_line": {
"line": "* Who had a pacemaker or history of open heart surgery",
"criterions": [
{
"exact_snippets": "Who had a pacemaker",
"criterion": "pacemaker",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of open heart surgery",
"criterion": "open heart surgery",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Who had a pacemaker",
"criterion": "pacemaker",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "history of open heart surgery",
"criterion": "open heart surgery",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}