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NCT Number: NCT06519240

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Approximately 12% of heart transplant recipients are treated for cardiac rejection during their first year of follow-up. Rejection is the cause of death in 8-10% of cases in the first three years. Currently, to diagnose cardiac rejection, patients require radiological imaging (for example echocardiography, or cardiac magnetic resonance imaging), and histological sampling, obtained invasively by performing a heart muscle biopsy ("endomyocardial biopsy").Biopsy is an invasive procedure with a serious risk of complications including cardiac tamponade and death. In addition, there are issues relating to sampling errors, as well as the interpretation of results, which can be semi-objective and challenging. Furthermore, as it is an invasive procedure, having a biopsy can cause anxiety and discomfort for patients. There is a clear need for a technique to diagnose cardiac rejection non-invasively, which can yield reliable and accurate results, permitting the prompt commencement of treatment.

Some studies in animals, and preliminary studies in humans, have shown potential for '18F-FDG PET CT' imaging to tackle this problem in diagnosing cardiac rejection. There is a clear need to undertake a large study, but it is not clear at this preliminary stage if this is feasible.

The investigators aim to perform this pilot study to determine if 18F-FDG PET CT imaging is acceptable for heart transplant patients, and to assess if it has the potential to diagnose cardiac rejection when compared to endometrial biopsy. It will also help provide data to assess sample size requirements to undertake a larger diagnostic study in the future. If this imaging modality is found to be beneficial, cardiac rejection may be reliably diagnosed sooner, resulting in prompt treatment and improvement in quality of life, with better prognosis in heart transplant recipients.

Each group, would undertake a resting Rubidium PET scan, jointly with a FDG PET scan at the same visit to exclude cardiac injury from previous cardiac events, and to assess heart function. An experienced consultant in nuclear medicine (who will remain blinded to the patient identification and medical history) will report the findings of the imaging to the study investigators.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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
  • Insulin dependent diabetics
  • Pregnant or breast feeding individuals

Treatment and study plan

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.

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)

    Time frame: 18 months

    We aim to confirm the sensitivity and specificity of FDG PET CT in diagnosing cardiac rejection

Secondary outcomes

  1. Practicality and acceptability of FDG PET CT imaging to patients

    Time frame: 18 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Owais Dar, MRCP MD(Res)

CONTACT

[email protected]

+44(0)1895828898

Ramey Assaf, MBBS BMedSci

CONTACT

[email protected]

+44(0)1895828898

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 25, 2024
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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