Fluorocholine PET/CT Clinical Trial
Official title:
Performance of 18F-Fluorocholine Positron Emission Tomography With Computed Tomography in Patients With 18F-Fluorocholine-avid Lesions: A Basket Trial
| Verified date | April 2024 |
| Source | Sir Mortimer B. Davis - Jewish General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 2000 |
| Est. completion date | July 2030 |
| Est. primary completion date | January 2030 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 110 Years |
| Eligibility | Inclusion Criteria: - Age 18 years or older - Under referring physician's care - Able to understand and provide written informed consent - Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 30 minutes and tolerating intravenous cannulation for injection - Known or suspected benign or malignant tumor which is known or suspected to be 18F-fluorocholine-avid as per current medical literature Exclusion Criteria: - Medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) - Exceeding the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or cannot fit through the PET/CT bore (usually approximately 70 cm diameter) - Unmanageable claustrophobia |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Jewish General Hospital | Montreal | Quebec |
| Lead Sponsor | Collaborator |
|---|---|
| Sir Mortimer B. Davis - Jewish General Hospital |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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 |