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Fluorocholine PET/CT Basket Trial

StatusEnrolling by Invitation
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv10
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2022 to Nov 30, 2022
    v9
  3. Start date: Jul 2022 to Dec 2022v8
  4. Start date: Dec 2021 to Jul 2022v7
  5. Start date: Jun 2021 to Dec 2021v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Dec 2020 to Jun 2021v5
  2. Start date: Jun 2020 to Dec 2020v4
  3. Start date: Jan 2020 to Jun 2020v3
  4. Primary endpoint revised
    • Secondary endpoint revised
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04150458
Lead Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Conditions
(from sponsor)		 Fluorocholine PET/CT
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov