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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorRoyal Brompton & Harefield NHS Foundation Trust

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)

    Radiation

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Patients with a diagnosis of cardiac rejectionActive comparator 1 intervention
Group B: Patients with no evidence of cardiac rejectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
18 months

Secondary outcomes

1

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.

Time frame
18 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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