Fluorocholine PET/CT Basket Trial

Sir Mortimer B. Davis - Jewish General Hospital

Status and phase: Invitation-only; Phase 3

Conditions: Fluorocholine PET/CT

Treatments: Drug: 18F-fluorocholine PET/CT.

Study type: Interventional

Funder types: Other

Identifiers

NCT04150458

FCH Basket

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,000 participants in 1 patient group

Fluorocholine PET/CT

Experimental group

Description:

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.

Treatment:

Drug: 18F-fluorocholine PET/CT.