Cardiac Transplant RejectionNCT06519240
A Pilot Study Evaluating the Potential of 18F Fluorodeoxyglucose PET-CT Imaging in Diagnosing Cardiac Rejection.
A study testing 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT) in people with Cardiac Transplant Rejection, run by Royal Brompton & Harefield NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Transplant Rejection
- What is being tested?
- 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2024to 2 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this 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.
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.
Read the detailed description
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.
- Conditions
- Cardiac Transplant Rejection
- Being tested
- 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a diagnosis of cardiac rejection | Active comparator | Based on heart muscle biopsy findings. Subjects must have no significant coronary disease within the last 12 months (with a confirmatory angiogram, computed tomography coronary angiogram, myocardial perfusion scan, cardiac magnetic resonance imagining, or other coronary ischaemia test. Receives: Radiation: 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT) |
| Patients with no evidence of cardiac rejection | Active comparator | Based on heart muscle biopsy findings Receives: Radiation: 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start30 Sep 2024 (estimated)
- Primary completion2 Oct 2025 (estimated)
- Study completion2 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mansimran Dulay, MBBS MRCP, Study director, Royal Brompton and Harefield Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519240
- Sponsor's protocol ID
- 335590/1660859/37/429
- Status last verified
- Jul 2024
- First submitted
- 2 May 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data (IPD)
Publications
Daly KP, Dearling JL, Seto T, Dunning P, Fahey F, Packard AB, Briscoe DM. Use of [18F]FDG Positron Emission Tomography to Monitor the Development of Cardiac Allograft Rejection. Transplantation. 2015 Sep;99(9):e132-9. doi: 10.1097/TP.0000000000000618.
PubMed 25675207
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06519240
- Acronym / sponsor ID
- 335590/1660859/37/429
- Conditions
- Cardiac Transplant Rejection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Sep 2024 (estimated)
- Primary completion
- 2 Oct 2025 (estimated)
- Study completion
- 2 Oct 2026 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with a diagnosis of cardiac rejection | Active comparator | Radiation: 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)Based on heart muscle biopsy findings. Subjects must have no significant coronary disease within the last 12 months (with a confirmatory angiogram, computed tomography coronary angiogram, myocardial perfusion scan, cardiac magnetic resonance imagining, or other coronary ischaemia test. |
| Patients with no evidence of cardiac rejection | Active comparator | Radiation: 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT)Based on heart muscle biopsy findings |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | Patients with a diagnosis of cardiac rejection, Patients with no evidence of cardiac rejection |
Primary outcome
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
1 secondary outcome
Practicality and acceptability of FDG PET CT imaging to patients
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Results publication: PubMed 25675207Daly KP, Dearling JL, Seto T, Dunning P, Fahey F, Packard AB, Briscoe DM. Use of [18F]FDG Positron Emission Tomography to Monitor the Development of Cardiac Allograft Rejection. Transplantation. 2015 Sep;99(9):e132-9. doi: 10.1097/TP.0000000000000618.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data (IPD)
Related trials for Cardiac Transplant Rejection
Not yet recruiting
Molecular Evidence of Rejection Intervention Trial
Heart Transplant Rejection
Not yet recruiting
Superiority Assessment of Donor-derived Cell-FreE DNA ( Deoxyribonucleic Acid) for Cardiac Allograft REjection Monitoring
Heart Transplantation
Enrolling by invitationObservational study
Donor Derived Cell Free DNA (Dd-cfDNA) as a Biomarker for Allograft Rejection in Heart Transplant Recipients
Heart Transplantation
RecruitingObservational study
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Heart Failure, Liver Fibrosis
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Trifecta-Heart cfDNA-MMDx Study
Heart Transplant Rejection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mansimran Dulay, MBBS MRCP study director
Royal Brompton and Harefield Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 18F-Fluorodeoxyglucose Positron Emission Tomography-computed Tomography (18F-FDG PET CT) in people with Cardiac Transplant Rejection, run by Royal Brompton & Harefield NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Owais Dar, MRCP MD(Res) (+44(0)1895828898, o.dar@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06519240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.