NCT04150458

Fluorocholine PET/CT Basket Trial

Performance of 18F-Fluorocholine Positron Emission Tomography With Computed Tomography in Patients With 18F-Fluorocholine-avid Lesions: A Basket Trial

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fluorocholine PET/CT

Interventions

Type	Name	Description
DRUG	18F-fluorocholine PET/CT.	18F-fluorocholine positron emission tomography / computed tomography

Timeline

• Start date: 2022-11-30
• Primary completion: 2030-01-01
• Completion: 2030-07-01
• First posted: 2019-11-04
• Last updated: 2024-04-17

Locations

1 site across 1 country: Canada