By InvitationPhase 3

Fluorocholine PET/CT Basket Trial

Canada2,000 participantsStarted 2022-11-30

Plain-language 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.

Who can participate

Age range18 Years – 110 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Diagnostic accuracy of Fluorocholine PET/CT

Timeframe: 1 day

Trial details

NCT IDNCT04150458

SponsorSir Mortimer B. Davis - Jewish General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-01

View on ClinicalTrials.gov More Fluorocholine PET/CT trials