{
"info": {
"nct_id": "NCT01482182",
"official_title": "Prediction of Chemotherapy Response and Patient Prognosis in Non-small Cell Lung Cancer: Dynamic Contrast-enhanced MRI and Diffusion-weighted Imaging Versus Volume-based Parameter of 18F-FDG PET",
"inclusion_criteria": "* Histologically proven NSCLC\n* Newly diagnosed Stage stage IV\n* Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy\n* At least one measurable primary or other intrathoracic lesion >= 2cm, according to RECIST\n* Performance status of 0 to 2 on the ECOG scale\n* Age 18 years or older\n* Able to tolerable PET/CT and MRI imaging required by protocol\n* Able to give study-specific informed consent\nHealthy volunteers allowed\nMust have minimum age of 20 Years",
"exclusion_criteria": "* Pure bronchioloalveolar cell carcinoma histology\n* Thoracic radiotherapy, lung surgery or chemotherapy within three months prior to inclusion in the study\n* Poorly controlled diabetes\n* Prior malignancy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Histologically proven NSCLC",
"criterions": [
{
"exact_snippets": "Histologically proven NSCLC",
"criterion": "NSCLC",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically proven"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Histologically proven NSCLC",
"criterion": "NSCLC",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histologically proven"
}
}
]
}
},
{
"identified_line": {
"line": "* Newly diagnosed Stage stage IV",
"criterions": [
{
"exact_snippets": "Newly diagnosed Stage stage IV",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IV"
}
},
{
"exact_snippets": "Newly diagnosed Stage stage IV",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": "newly diagnosed"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Newly diagnosed Stage stage IV",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IV"
}
},
{
"exact_snippets": "Newly diagnosed Stage stage IV",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": "newly diagnosed"
}
}
]
}
},
{
"identified_line": {
"line": "* Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy",
"criterions": [
{
"exact_snippets": "Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy",
"criterion": "chemotherapy with EGFR TKI",
"requirement": {
"requirement_type": "line of therapy",
"expected_value": "first line"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy",
"criterion": "chemotherapy with EGFR TKI",
"requirement": {
"requirement_type": "line of therapy",
"expected_value": "first line"
}
}
]
}
},
{
"identified_line": {
"line": "* At least one measurable primary or other intrathoracic lesion >= 2cm, according to RECIST",
"criterions": [
{
"exact_snippets": "At least one measurable primary or other intrathoracic lesion >= 2cm",
"criterion": "intrathoracic lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "N/A"
}
}
},
{
"exact_snippets": "At least one measurable primary or other intrathoracic lesion >= 2cm",
"criterion": "intrathoracic lesion",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
},
{
"exact_snippets": "At least one measurable primary or other intrathoracic lesion >= 2cm",
"criterion": "intrathoracic lesion",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "cm"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "At least one measurable primary or other intrathoracic lesion >= 2cm",
"criterion": "intrathoracic lesion",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1,
"unit": "N/A"
}
}
},
{
"exact_snippets": "At least one measurable primary or other intrathoracic lesion >= 2cm",
"criterion": "intrathoracic lesion",
"requirement": {
"requirement_type": "measurability",
"expected_value": true
}
}
]
},
{
"exact_snippets": "At least one measurable primary or other intrathoracic lesion >= 2cm",
"criterion": "intrathoracic lesion",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "cm"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Performance status of 0 to 2 on the ECOG scale",
"criterions": [
{
"exact_snippets": "Performance status of 0 to 2 on the ECOG scale",
"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 0 to 2 on the ECOG scale",
"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": "* Age 18 years or older",
"criterions": [
{
"exact_snippets": "Age 18 years or older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age 18 years or older",
"criterion": "age",
"requirement": {
"requirement_type": "minimum age",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Able to tolerable PET/CT and MRI imaging required by protocol",
"criterions": [
{
"exact_snippets": "Able to tolerable PET/CT and MRI imaging",
"criterion": "tolerance to imaging",
"requirement": {
"requirement_type": "tolerance",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to tolerable PET/CT and MRI imaging",
"criterion": "tolerance to imaging",
"requirement": {
"requirement_type": "tolerance",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Able to give study-specific informed consent",
"criterions": [
{
"exact_snippets": "Able to give study-specific informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Able to give study-specific informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "ability",
"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 have minimum age of 20 Years",
"criterions": [
{
"exact_snippets": "minimum age of 20 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 20 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 20,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Pure bronchioloalveolar cell carcinoma histology",
"criterions": [
{
"exact_snippets": "Pure bronchioloalveolar cell carcinoma histology",
"criterion": "bronchioloalveolar cell carcinoma histology",
"requirement": {
"requirement_type": "purity",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Pure bronchioloalveolar cell carcinoma histology",
"criterion": "bronchioloalveolar cell carcinoma histology",
"requirement": {
"requirement_type": "purity",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Thoracic radiotherapy, lung surgery or chemotherapy within three months prior to inclusion in the study",
"criterions": [
{
"exact_snippets": "Thoracic radiotherapy ... within three months prior to inclusion in the study",
"criterion": "thoracic radiotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "lung surgery ... within three months prior to inclusion in the study",
"criterion": "lung surgery",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
},
{
"exact_snippets": "chemotherapy within three months prior to inclusion in the study",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Thoracic radiotherapy ... within three months prior to inclusion in the study",
"criterion": "thoracic radiotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "lung surgery ... within three months prior to inclusion in the study",
"criterion": "lung surgery",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "chemotherapy within three months prior to inclusion in the study",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "months"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Poorly controlled diabetes",
"criterions": [
{
"exact_snippets": "Poorly controlled diabetes",
"criterion": "diabetes",
"requirement": {
"requirement_type": "control",
"expected_value": "poorly controlled"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Poorly controlled diabetes",
"criterion": "diabetes",
"requirement": {
"requirement_type": "control",
"expected_value": "poorly controlled"
}
}
}
},
{
"identified_line": {
"line": "* Prior malignancy",
"criterions": [
{
"exact_snippets": "Prior malignancy",
"criterion": "prior malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Prior malignancy",
"criterion": "prior malignancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}