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A Pilot Study Evaluating the Potential of 18F Fluorodeoxyglucose PET-CT Imaging in Diagnosing Cardiac Rejection.
Sponsor: Royal Brompton & Harefield NHS Foundation Trust
Summary
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.
Official title: A Prospective Blinded Pilot Study Evaluating the Sensitivity and Specificity of 18F Fluorodeoxyglucose PET CT Imaging (a Non-invasive Imaging Tool) for the Diagnosis of Rejection in Heart Transplant Recipients.
Key Details
Gender
All
Age Range
18 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-09-30
Completion Date
2026-10-02
Last Updated
2024-07-25
Healthy Volunteers
Yes
Conditions
Interventions
18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)
Each participant will prepare for their study PET CT by following an initial 18 hour of zero carbohydrate diet followed by another 18 hours of fasting (water allowed). After confirming preparation, each study participant will have a single rest rubidium and 18F-FDG PET CT scan.