At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- 68Ga-FAPI and 18F-AlF-FAPI PET-MR (diagnostic test)
- How long the study runs
- Study runs about 44 months (dates as stated)
- About the drug or intervention
- 68Ga-FAPI and 18F-AlF-FAPI PET-MR — diagnostic test: Hybrid Cardiac PET-MR with 68Ga-FAPI and 18F-AlF-FAPI radiotracer
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 40 Years to 90 Years
- Who
- All
- Number of participants
- 50
- Started
- 2022-11-10
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for aortic stenosis
- • Clinical study - 50 participants
- • In this study the investigators aim to examine the role that fibrosis plays in heart conditions such as aortic stenosis , chemotherapy-induced cardiotoxicity and carcinoid syndrome
Who can take part?
- • Ages 40 Years to 90 Years
- • Diagnosed with aortic stenosis
Where?
- • Edinburgh - University of Edinburgh
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
In this study the investigators aim to examine the role that fibrosis plays in heart conditions such as aortic stenosis , chemotherapy-induced cardiotoxicity and carcinoid syndrome . Fibrosis is a common final result following any injury to the heart muscle and the investigators aim to identify this process early and in its active state. This will be examined by using a radiotracer 68Ga-FAPI or 18F-AlF-FAPI and PET-MRI or PET-CT.
More detail
The investigators aim to investigate the role of fibrosis activity using 68Ga-FAPI and 18F-AlF-FAPI PET in chronic and delayed valvular, myocardial and endocardial injury states, in particular aortic stenosis, chemotherapy induced cardiotoxicity and carcinoid heart disease. The investigators also aim to analyse serum markers of myocardial injury and fibrosis at different time-points in these patient cohorts. Research Hypothesis 1. In patients with aortic stenosis, myocardial fibrosis activity will correlate with markers of left ventricular decompensation and aortic valve fibrosis activity, will predict progression in fibrosis burden and will decline following aortic valve replacement. 2. Increased myocardial fibrosis activity will be observed in the early stages of anthracycline- induced cardiotoxicity and will predict later deterioration in cardiac function. 3. In patients with carcinoid syndrome, increased endocardial fibrosis activity will be observed in patients with subclinical and clinically significant valve involvement.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years - 90 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Cohort 1(Aortic stenosis):
- ✓Male or female above the age of 50 years old
- ✓Provision of agreement to take part prior to any study specific procedures
- ✓25 patients with causing symptoms severe aortic stenosis (peak velocity \>4.0 m/s)
- ✓25 patients with moderate aortic stenosis (peak velocity 3.0-4.0 m/s)
Who cannot take part
- ✗Inability or unwilling to give agreement to take part.
- ✗History of claustrophobia or feeling of inability to tolerate supine position for the MRI scans.
- ✗Impaired kidney function with eGFR of \<30 mL/min/1.73m2.
- ✗Women who are pregnant or breastfeeding.
- ✗Contrast allergy
See the full criteria
Where Is This Study? (1 UK site)
University of Edinburgh
Edinburgh NE7 7EY, United Kingdom
