Performance of 18F-Fluorocholine Positron Emission Tomography With Computed Tomography in Patients With 18F-Fluorocholine-avid Lesions: A Basket Trial
Overview
- Phase
- Phase 3
- Intervention
- 18F-fluorocholine PET/CT.
- Conditions
- Fluorocholine PET/CT
- Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
- Enrollment
- 2000
- Locations
- 1
- Primary Endpoint
- Diagnostic accuracy of Fluorocholine PET/CT
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Stephan Probst, MD
Chief of Nuclear Medicine
Sir Mortimer B. Davis - Jewish General Hospital
Eligibility Criteria
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
Arms & Interventions
Fluorocholine PET/CT
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.
Intervention: 18F-fluorocholine PET/CT.
Outcomes
Primary Outcomes
Diagnostic accuracy of Fluorocholine PET/CT
Time Frame: 1 day
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.
Secondary Outcomes
- Incidence of treatment-emergent adverse events following Fluorocholine PET/CT(30 minutes)