{
"info": {
"nct_id": "NCT06205901",
"official_title": "A Prospective Comparison Study Between 18F-FDG PET/CT and Whole-Body Diffusion Weighted MRI in the Detection of Distant Malignancies in Patients With Various Cancers",
"inclusion_criteria": "* Only patients with malignancies proven by histology and patients with metastatic lesions proven by histopathology or cytology were included.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 100 Years",
"exclusion_criteria": "* • As regard the PET/CT study, patients who have the general CT contraindications such as pregnancy, breast feeding, history of allergic reaction to the contrast medium, renal disease, etc.\n\n * As regard the MRI study, general contraindications including claustrophobia, MR-incompatible pacemakers and MR-incompatible heart valves.\n * Patients whose MRI sequences were incomplete, low-quality and/or had no histopathological evidence of metastatic lesions were eliminated from the study.\n * Low-quality or incomplete MRI included MRI exams with incomplete sequence(s), which is particularly common in elderly patients who are unable to tolerate the scan, or uncooperative patients who do not obey breathing instructions and motion artifacts that may impair images and lead to lower accuracy.\n * Declined consent.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Only patients with malignancies proven by histology and patients with metastatic lesions proven by histopathology or cytology were included.",
"criterions": [
{
"exact_snippets": "malignancies proven by histology",
"criterion": "malignancies",
"requirements": [
{
"requirement_type": "proof method",
"expected_value": "histology"
}
]
},
{
"exact_snippets": "metastatic lesions proven by histopathology or cytology",
"criterion": "metastatic lesions",
"requirements": [
{
"requirement_type": "proof method",
"expected_value": [
"histopathology",
"cytology"
]
}
]
}
]
},
{
"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 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 100 Years",
"criterions": [
{
"exact_snippets": "maximum age of 100 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 100,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* • As regard the PET/CT study, patients who have the general CT contraindications such as pregnancy, breast feeding, history of allergic reaction to the contrast medium, renal disease, etc.",
"criterions": [
{
"exact_snippets": "pregnancy",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "breast feeding",
"criterion": "breast feeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "history of allergic reaction to the contrast medium",
"criterion": "allergic reaction to contrast medium",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
},
{
"exact_snippets": "renal disease",
"criterion": "renal disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* As regard the MRI study, general contraindications including claustrophobia, MR-incompatible pacemakers and MR-incompatible heart valves.",
"criterions": [
{
"exact_snippets": "general contraindications including claustrophobia",
"criterion": "claustrophobia",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "general contraindications including ... MR-incompatible pacemakers",
"criterion": "MR-incompatible pacemakers",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "general contraindications including ... MR-incompatible heart valves",
"criterion": "MR-incompatible heart valves",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients whose MRI sequences were incomplete, low-quality and/or had no histopathological evidence of metastatic lesions were eliminated from the study.",
"criterions": [
{
"exact_snippets": "MRI sequences were incomplete",
"criterion": "MRI sequences",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": true
}
]
},
{
"exact_snippets": "MRI sequences were ... low-quality",
"criterion": "MRI sequences",
"requirements": [
{
"requirement_type": "quality",
"expected_value": "high"
}
]
},
{
"exact_snippets": "no histopathological evidence of metastatic lesions",
"criterion": "histopathological evidence of metastatic lesions",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Low-quality or incomplete MRI included MRI exams with incomplete sequence(s), which is particularly common in elderly patients who are unable to tolerate the scan, or uncooperative patients who do not obey breathing instructions and motion artifacts that may impair images and lead to lower accuracy.",
"criterions": [
{
"exact_snippets": "Low-quality or incomplete MRI ... incomplete sequence(s)",
"criterion": "MRI quality",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": true
}
]
},
{
"exact_snippets": "elderly patients who are unable to tolerate the scan",
"criterion": "patient age",
"requirements": [
{
"requirement_type": "tolerance to scan",
"expected_value": true
}
]
},
{
"exact_snippets": "uncooperative patients who do not obey breathing instructions",
"criterion": "patient cooperation",
"requirements": [
{
"requirement_type": "obedience to breathing instructions",
"expected_value": true
}
]
},
{
"exact_snippets": "motion artifacts that may impair images",
"criterion": "motion artifacts",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Declined consent.",
"criterions": [
{
"exact_snippets": "Declined consent",
"criterion": "consent",
"requirements": [
{
"requirement_type": "status",
"expected_value": "declined"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}