{
"info": {
"nct_id": "NCT02766530",
"official_title": "Use of Integrated PET/MR to Evaluate Clinical Staging and Monitor Treatment Response of Neoadjuvant Chemotherapy for Breast Cancer Patients: A Pilot Study",
"inclusion_criteria": "1. Women aged 25-75 years old.\n2. Women with recently diagnosed breast cancer and who will receive NAC to reduce tumor burden before surgery. (including locally advanced breast cancer (LABC) according to clinical assessment; or tumor size > 2cm, that is, at least T2 in TNM staging).\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 25 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "1. Estimated GFR (eGFR) < 60 mL/min/1.73 m2 and blood glucose > 135 mg/dl; Past or present history of acute renal failure, renal dialysis, diabetes mellitus.\n2. Women who received metallic fixation, coronary artery stent in recent 3 months; or women who received mechanical valve replacement that is not compatible with MR magnet; or women with aneurysmal clips, pacemakers.\n3. Past history of claustrophobia.\n4. Women who are pregnant or who are planning to be pregnant, or who are lactating (though the possibility in our target population should be very low)\n5. Past history of breast cancer within recent 5 years before the currently diagnosed breast cancer.\n6. Women who received chemotherapy for other disease entity in recent 1 year.\n7. Women who cannot cooperate with the examinations.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "1. Women aged 25-75 years old.",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirement": {
"requirement_type": "N/A",
"expected_value": "female"
}
},
{
"exact_snippets": "aged 25-75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 25,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirement": {
"requirement_type": "N/A",
"expected_value": "female"
}
},
{
"exact_snippets": "aged 25-75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 25,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "2. Women with recently diagnosed breast cancer and who will receive NAC to reduce tumor burden before surgery. (including locally advanced breast cancer (LABC) according to clinical assessment; or tumor size > 2cm, that is, at least T2 in TNM staging).",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirement": {
"requirement_type": "N/A",
"expected_value": "female"
}
},
{
"exact_snippets": "recently diagnosed breast cancer",
"criterion": "breast cancer diagnosis",
"requirement": {
"requirement_type": "recency",
"expected_value": "recently diagnosed"
}
},
{
"exact_snippets": "will receive NAC",
"criterion": "neoadjuvant chemotherapy (NAC)",
"requirement": {
"requirement_type": "planned treatment",
"expected_value": true
}
},
{
"exact_snippets": "locally advanced breast cancer (LABC) according to clinical assessment",
"criterion": "locally advanced breast cancer (LABC)",
"requirement": {
"requirement_type": "clinical assessment",
"expected_value": true
}
},
{
"exact_snippets": "tumor size > 2cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "cm"
}
}
},
{
"exact_snippets": "at least T2 in TNM staging",
"criterion": "TNM staging",
"requirement": {
"requirement_type": "stage",
"expected_value": "at least T2"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirement": {
"requirement_type": "N/A",
"expected_value": "female"
}
},
{
"exact_snippets": "recently diagnosed breast cancer",
"criterion": "breast cancer diagnosis",
"requirement": {
"requirement_type": "recency",
"expected_value": "recently diagnosed"
}
},
{
"exact_snippets": "will receive NAC",
"criterion": "neoadjuvant chemotherapy (NAC)",
"requirement": {
"requirement_type": "planned treatment",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "locally advanced breast cancer (LABC) according to clinical assessment",
"criterion": "locally advanced breast cancer (LABC)",
"requirement": {
"requirement_type": "clinical assessment",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "tumor size > 2cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 2,
"unit": "cm"
}
}
},
{
"exact_snippets": "at least T2 in TNM staging",
"criterion": "TNM staging",
"requirement": {
"requirement_type": "stage",
"expected_value": "at least T2"
}
}
]
}
]
}
]
}
},
{
"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": "N/A",
"expected_value": "FEMALE"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
"requirement_type": "N/A",
"expected_value": "FEMALE"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 25 Years",
"criterions": [
{
"exact_snippets": "minimum age of 25 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 25,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 25 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 25,
"unit": "Years"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "1. Estimated GFR (eGFR) < 60 mL/min/1.73 m2 and blood glucose > 135 mg/dl; Past or present history of acute renal failure, renal dialysis, diabetes mellitus.",
"criterions": [
{
"exact_snippets": "Estimated GFR (eGFR) < 60 mL/min/1.73 m2",
"criterion": "estimated GFR (eGFR)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 60,
"unit": "mL/min/1.73 m2"
}
}
},
{
"exact_snippets": "blood glucose > 135 mg/dl",
"criterion": "blood glucose",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 135,
"unit": "mg/dl"
}
}
},
{
"exact_snippets": "Past or present history of acute renal failure",
"criterion": "acute renal failure",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Past or present history of ... renal dialysis",
"criterion": "renal dialysis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Past or present history of ... diabetes mellitus",
"criterion": "diabetes mellitus",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Estimated GFR (eGFR) < 60 mL/min/1.73 m2",
"criterion": "estimated GFR (eGFR)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 60,
"unit": "mL/min/1.73 m2"
}
}
},
{
"exact_snippets": "blood glucose > 135 mg/dl",
"criterion": "blood glucose",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 135,
"unit": "mg/dl"
}
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "Past or present history of acute renal failure",
"criterion": "acute renal failure",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Past or present history of ... renal dialysis",
"criterion": "renal dialysis",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "Past or present history of ... diabetes mellitus",
"criterion": "diabetes mellitus",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "2. Women who received metallic fixation, coronary artery stent in recent 3 months; or women who received mechanical valve replacement that is not compatible with MR magnet; or women with aneurysmal clips, pacemakers.",
"criterions": [
{
"exact_snippets": "Women who received metallic fixation",
"criterion": "metallic fixation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "coronary artery stent in recent 3 months",
"criterion": "coronary artery stent",
"requirement": {
"requirement_type": "time since procedure",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "women who received mechanical valve replacement that is not compatible with MR magnet",
"criterion": "mechanical valve replacement",
"requirement": {
"requirement_type": "compatibility with MR magnet",
"expected_value": false
}
},
{
"exact_snippets": "women with aneurysmal clips",
"criterion": "aneurysmal clips",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "women with ... pacemakers",
"criterion": "pacemakers",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Women who received metallic fixation",
"criterion": "metallic fixation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "coronary artery stent in recent 3 months",
"criterion": "coronary artery stent",
"requirement": {
"requirement_type": "time since procedure",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
},
{
"exact_snippets": "women who received mechanical valve replacement that is not compatible with MR magnet",
"criterion": "mechanical valve replacement",
"requirement": {
"requirement_type": "compatibility with MR magnet",
"expected_value": false
}
},
{
"exact_snippets": "women with aneurysmal clips",
"criterion": "aneurysmal clips",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "women with ... pacemakers",
"criterion": "pacemakers",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "3. Past history of claustrophobia.",
"criterions": [
{
"exact_snippets": "Past history of claustrophobia",
"criterion": "claustrophobia",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Past history of claustrophobia",
"criterion": "claustrophobia",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "4. Women who are pregnant or who are planning to be pregnant, or who are lactating (though the possibility in our target population should be very low)",
"criterions": [
{
"exact_snippets": "Women who are pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "who are planning to be pregnant",
"criterion": "pregnancy planning",
"requirement": {
"requirement_type": "intention",
"expected_value": false
}
},
{
"exact_snippets": "who are lactating",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Women who are pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "who are planning to be pregnant",
"criterion": "pregnancy planning",
"requirement": {
"requirement_type": "intention",
"expected_value": false
}
},
{
"exact_snippets": "who are lactating",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "5. Past history of breast cancer within recent 5 years before the currently diagnosed breast cancer.",
"criterions": [
{
"exact_snippets": "Past history of breast cancer within recent 5 years",
"criterion": "past history of breast cancer",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Past history of breast cancer within recent 5 years",
"criterion": "past history of breast cancer",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 5,
"unit": "years"
}
]
}
}
}
}
},
{
"identified_line": {
"line": "6. Women who received chemotherapy for other disease entity in recent 1 year.",
"criterions": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "female"
}
},
{
"exact_snippets": "received chemotherapy",
"criterion": "chemotherapy history",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "other disease entity",
"criterion": "disease entity",
"requirement": {
"requirement_type": "type",
"expected_value": "other"
}
},
{
"exact_snippets": "recent 1 year",
"criterion": "time since chemotherapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "year"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Women",
"criterion": "gender",
"requirement": {
"requirement_type": "value",
"expected_value": "female"
}
},
{
"exact_snippets": "received chemotherapy",
"criterion": "chemotherapy history",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "other disease entity",
"criterion": "disease entity",
"requirement": {
"requirement_type": "type",
"expected_value": "other"
}
},
{
"exact_snippets": "recent 1 year",
"criterion": "time since chemotherapy",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "year"
}
}
}
]
}
},
{
"identified_line": {
"line": "7. Women who cannot cooperate with the examinations.",
"criterions": [
{
"exact_snippets": "Women who cannot cooperate with the examinations",
"criterion": "cooperation with examinations",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Women who cannot cooperate with the examinations",
"criterion": "cooperation with examinations",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}