Fluorocholine PET/CT Basket Trial

Phase 3

• Conditions: Fluorocholine PET/CT
• Interventions: Drug: 18F-fluorocholine PET/CT.

• Registration Number: NCT04150458
• Lead Sponsor: Sir Mortimer B. Davis - Jewish General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-04
• Study Start: 2022-11-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2030-01
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fluorocholine PET/CT	18F-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.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of Fluorocholine PET/CT	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 Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events following Fluorocholine PET/CT	30 minutes	Unexpected immediate adverse events up to 30 minutes post-administration of 18F-fluorocholine.

Trial Locations

Locations (1)

Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada