{
"info": {
"nct_id": "NCT06126172",
"official_title": "Radiomics of Treatment-naive Prostate Cancer Patients on Multiparametric MRI for Risk Stratification and Treatment Outcomes Predictions",
"inclusion_criteria": "1. Aged over 20 years old.\n2. Suspected or confirmed prostate cancer.\n3. Undergoing prostate mpMRI before clinical treatment.\n4. Normal renal function(i.e.: estimated GFR ≧60).\n5. No allergy history to gadolinium based contrast agent.\n6. Agree to participate this study and sign informed consent.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 20 Years",
"exclusion_criteria": "1. mpMRI photography not completed.\n2. mpMRI images are damaged or poor in quality and cannot be interpreted.\n3. Without pathological examination confirmed prostate cancer.\n4. Patient withdraw informed consent.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Aged over 20 years old.",
"criterions": [
{
"exact_snippets": "Aged over 20 years old.",
"criterion": "age",
"requirements": [
{
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 20,
"unit": "years"
}
}
]
}
]
},
{
"line": "2. Suspected or confirmed prostate cancer.",
"criterions": [
{
"exact_snippets": "Suspected or confirmed prostate cancer",
"criterion": "prostate cancer",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"suspected",
"confirmed"
]
}
]
}
]
},
{
"line": "3. Undergoing prostate mpMRI before clinical treatment.",
"criterions": [
{
"exact_snippets": "Undergoing prostate mpMRI",
"criterion": "prostate mpMRI",
"requirements": [
{
"requirement_type": "status",
"expected_value": "undergoing"
}
]
}
]
},
{
"line": "4. Normal renal function(i.e.: estimated GFR ≧60).",
"criterions": [
{
"exact_snippets": "Normal renal function(i.e.: estimated GFR ≧60)",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "GFR",
"expected_value": {
"operator": ">=",
"value": 60,
"unit": "N/A"
}
}
]
}
]
},
{
"line": "5. No allergy history to gadolinium based contrast agent.",
"criterions": [
{
"exact_snippets": "No allergy history to gadolinium based contrast agent.",
"criterion": "allergy history to gadolinium based contrast agent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "6. Agree to participate this study and sign informed consent.",
"criterions": [
{
"exact_snippets": "Agree to participate this study",
"criterion": "study participation agreement",
"requirements": [
{
"requirement_type": "agreement",
"expected_value": true
}
]
},
{
"exact_snippets": "sign informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "signed",
"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 be MALE",
"criterions": [
{
"exact_snippets": "Must be MALE",
"criterion": "gender",
"requirements": [
{
"requirement_type": "value",
"expected_value": "male"
}
]
}
]
},
{
"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"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "1. mpMRI photography not completed.",
"criterions": [
{
"exact_snippets": "mpMRI photography not completed",
"criterion": "mpMRI photography",
"requirements": [
{
"requirement_type": "completion",
"expected_value": true
}
]
}
]
},
{
"line": "2. mpMRI images are damaged or poor in quality and cannot be interpreted.",
"criterions": [
{
"exact_snippets": "mpMRI images are damaged",
"criterion": "mpMRI images",
"requirements": [
{
"requirement_type": "condition",
"expected_value": "damaged"
}
]
},
{
"exact_snippets": "mpMRI images are ... poor in quality",
"criterion": "mpMRI images",
"requirements": [
{
"requirement_type": "quality",
"expected_value": "poor"
}
]
},
{
"exact_snippets": "mpMRI images ... cannot be interpreted",
"criterion": "mpMRI images",
"requirements": [
{
"requirement_type": "interpretability",
"expected_value": false
}
]
}
]
},
{
"line": "3. Without pathological examination confirmed prostate cancer.",
"criterions": [
{
"exact_snippets": "pathological examination confirmed prostate cancer",
"criterion": "prostate cancer",
"requirements": [
{
"requirement_type": "confirmation method",
"expected_value": "pathological examination"
}
]
}
]
},
{
"line": "4. Patient withdraw informed consent.",
"criterions": [
{
"exact_snippets": "Patient withdraw informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "status",
"expected_value": "withdrawn"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}