Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519240
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-05-02
Brief Title:
A Pilot Study Evaluating the Potential of 18F Fluorodeoxyglucose PET-CT Imaging in Diagnosing Cardiac Rejection
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 biopsyBiopsy 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None