Fluorocholine PET/CT Basket Trial

NCT04150458 | Enrolling By Invitation Phase 3

• 1 other identifier: FCH Basket
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluorocholine PET/CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of treatment-emergent adverse events following Fluorocholine PET/CT

  30 minutes

Study Arms (1)

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.

Drug: 18F-fluorocholine PET/CT.

Interventions

18F-fluorocholine PET/CT. DRUG

18F-fluorocholine positron emission tomography / computed tomography

Also known as: FCH PET/CT, F-choline PET/CT

Fluorocholine PET/CT

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Mortimer B. Davis - Jewish General Hospital: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

Study Officials

• Stephan Probst, MD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nuclear Medicine

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: November 30, 2022
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)