Actively Recruiting
Fibrosis in Chronic and Delayed Myocardial Infarction Using 68Ga-FAPI and 18F-AlF-FAPI PET-MR Imaging to Study Aortic Stenosis, Chemotherapy-Induced Cardiotoxicity, and Carcinoid Syndrome
Led by University of Edinburgh · Updated on 2026-01-09
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how fibrosis, a common heart muscle injury result, affects conditions like aortic stenosis, chemotherapy-induced cardiotoxicity, and carcinoid syndrome. The study aims to detect active fibrosis early using radiotracers 68Ga-FAPI or 18F-AlF-FAPI combined with PET-MRI or PET-CT imaging. They also plan to analyze blood markers related to heart injury and fibrosis over time in these groups. The study involves three patient cohorts: 70 patients with varying severity of aortic stenosis and 10 healthy volunteers will have baseline PET/MR scans to measure fibrosis activity, with a follow-up scan one year later to observe changes after valve replacement or disease progression. Another group of 60 patients treated with anthracyclines, showing different levels of heart injury, and 10 healthy volunteers will have baseline PET/MR imaging and follow-up MRI 1-2 years later. The third group includes 30 patients with carcinoid syndrome undergoing baseline echocardiogram and PET/MR imaging, with follow-up echocardiogram and MRI 6 months to 1 year later. Participants will undergo detailed imaging scans and blood tests to assess heart fibrosis and function. The primary outcomes measured include standardized uptake values and tissue-to-background ratios of fibrosis activity over 1-2 years. Healthy volunteers participate for baseline comparisons but do not have repeat scans. The study is sponsored by the University of Edinburgh and will continue through August 2028.
CONDITIONS
Brief Title
Fibrosis in Chronic and Delayed Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female above the age of 50 years for aortic stenosis cohort
- Patients with symptomatic severe, moderate, mild aortic stenosis or aortic sclerosis
- Healthy volunteers with no significant co-morbidities assessed by the study doctor
- Male or female over age 35 with evidence of cardiotoxicity on cardiac MRI after anthracycline treatment
- Patients over 35 years without evidence of fibrosis post-anthracycline treatment
- Patients with carcinoid syndrome diagnosed by consensus guidelines, over age 35
- Provision of informed consent before any study-specific procedures
You will not qualify if you...
- Unable or unwilling to provide informed consent
- History of claustrophobia or inability to tolerate lying still for MRI scans
- Impaired kidney function with eGFR below 30 mL/min/1.73m2
- Pregnant or breastfeeding women
- Allergy to contrast agents
- Contraindications to cardiac MRI such as metallic implants or severe claustrophobia
- Recent heart attack or other known causes of cardiomyopathy or cardiac fibrosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline assessment
Participants undergo baseline 68Ga-FAPI or 18F-AlF-FAPI PET/MR imaging and relevant cardiac imaging tests to assess fibrosis activity and cardiac function.
1 baseline imaging visit (in-person)
Duration - 6 months to 2 years depending on cohort
Participants have follow-up cardiac imaging and assessments to monitor changes in fibrosis activity and cardiac function over time.
1 to 2 follow-up visits (in-person) depending on cohort assignment
Trial Site Locations
Total: 1 location
1
University of Edinburgh
Edinburgh, Scotland, United Kingdom, NE7 7EY
Actively Recruiting
Research Team
K
Krithika Loganath, MBBS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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