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A Pilot Study Evaluating the Potential of 18F Fluorodeoxyglucose PET-CT Imaging in Diagnosing Cardiac Rejection.

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 25, 2024 (before its estimated October 2, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Jul 2024); last known: Not Yet Recruiting
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 pilot study aims to assess whether 18F-FDG PET CT imaging has the potential in diagnosing cardiac rejection. The investigators aim to recruit 20 heart transplant subjects within two groups of 10 subjects each. One group will have participants with definite rejection and the other group will have participants with definite no rejection. Subjects will be placed into study groups based on their heart muscle biopsy, echocardiogram, clinical symptoms, ECG, and presence or absence of donor specific antibodies. Each group will then undertake a 18F-FDG PET CT scan to identify whether this imaging modality has a role in identifying cardiac rejection. The study subjects and the research team will be blinded to the results of the PET CT until the end of the study.
Trial Details
NCT Number NCT06519240
Lead Sponsor Royal Brompton & Harefield NHS Foundation Trust
Conditions
(from sponsor)		 Cardiac Transplant Rejection
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov