PET CT in heart transplant a diagnostic accuracy study
Research type
Research Study
Full 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.
IRAS ID
335590
Contact name
Owais Dar
Contact email
Sponsor organisation
Guy’s and St Thomas’ NHS Foundation Trust (GSTFT)
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Heart transplant (HTx) rejection is a problem. Approximately 12% of HTx recipients are treated for rejection during the first year of follow-up. Rejection is the cause of death in 8–10% of cases in the first three years. Currently, to diagnose HTx rejection, patients need to have an ultrasound of their heart ('echocardiogram'), or an invasive heart muscle biopsy ('endomyocardial biopsy').
These tests to diagnose rejection have their own problems. Biopsy is an invasive procedure with a serious risk of complications, including death. It is also prone to sampling error, and the interpretation can be objective and difficult. Because it is an invasive procedure, having a biopsy can cause anxiety and discomfort.
There is a clear need for a technique to diagnose cardiac rejection which is non-invasive, reliable, and can assess the entire heart in one go.
Some studies in animals, and preliminary studies in humans, have shown potential for '18F-FDG PET CT'scan to tackle this problem of diagnosing cardiac rejection. Results need confirming in a larger study, but we do not know if this is feasible.
We aim to do this pilot study to determine if 18F-FDG PET CT is acceptable for heart transplant patients, and to assess if it has a role to play in diagnosing rejection when compared to biopsy. It will also help provide data to help us calculate a sample size for a larger diagnostic study.
If this approach is overall found to be beneficial, cardiac rejection may be better diagnosed, treated, with resulting improvements in quality of life and prognosis for HTx recipients.
A resting Rubidium PET scan is jointly performed with a FDG PET scan at the same visit to rule out damage caused by a previous heart attack and to assess heart function.
REC name
London - Queen Square Research Ethics Committee
REC reference
24/LO/0083
Date of REC Opinion
12 Mar 2024
REC opinion
Further Information Favourable Opinion