About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All heart transplant recipients with definite cardiac rejection or definite no rejection with evidence of no significant coronary disease within the last 12 months (e.g with any of the following tests (1)angiogram (2) CTCA (3) MPS (4) CMR (5) other coronary ischaemia test)
Disqualifiers
Unable to have a PET CT scan or comply with the dietary protocol
Age less than 18 years old
Unable to consent
Presence of significant coronary disease or coronary ischaemia
Trial design
Parallel
Treatments tested in this trial
18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)
RadiationEach 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.
Treatment groups
Trial outcomes
Primary outcomes
Define the sensitivity and specificity of FDG PET CT in the diagnosis of cardiac rejection, when compared to the current clinical standard (cardiac biopsy and Echocardiography)
We aim to confirm the sensitivity and specificity of FDG PET CT in diagnosing cardiac rejection
Secondary outcomes
Practicality and acceptability of FDG PET CT imaging to patients
The investigators will aim to undertake a patient survey within 48 hours of the study taking place to ascertain the subjects whether undertaking FDG-PET CT imaging to patients is practical and acceptable to patients.
Locations
Sponsors and contacts
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