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This is a single-arm, open-label, phase III trial in up to 2000 patients with known or suspected benign or malignant tumors which are known or suspected to be 18F-fluorocholine-avid.
Patients will receive regular standard clinical care. The only study-specific procedure will be the administration of 18F-fluorocholine followed by a PET/CT scan.
Diagnostic accuracy of 18F-fluorocholine PET/CT will be captured versus a composite clinical, radiological and histopathological standard of truth at follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorocholine PET/CT | Experimental | The sole study-specific procedure is a single 18F-fluorocholine positron emission tomography / computed tomography (PET/CT). Subjects will receive 9 mCi 18F-fluorocholine IV, 5 to 120 minutes prior to PET/CT. 18F-fluorocholine PET/CT studies will be performed on hybrid PET/CT scanners which combine a dedicated, full-ring PET scanner with a multi-slice spiral CT scanner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-fluorocholine PET/CT. | Drug | 18F-fluorocholine positron emission tomography / computed tomography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of Fluorocholine PET/CT | Sensitivity, specificity, positive predictive and negative predictive values of 18F-fluorocholine PET/CT in the detection of tumor lesions as compared to a composite truth standard. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events following Fluorocholine PET/CT | Unexpected immediate adverse events up to 30 minutes post-administration of 18F-fluorocholine. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Probst, MD | Jewish General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jewish General Hospital | Montreal | Quebec | H3T1E2 | Canada |
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