Actively Recruiting
Molecular Imaging in Fabry Disease of the Heart
Led by University of Cambridge · Updated on 2024-07-22
12
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Cambridge
Lead Sponsor
S
Sanofi
Collaborating Sponsor
AI-Summary
What this Trial Is About
Better methods for early detection of cardiac involvement in Fabry disease are needed to inform clinical management decisions that can help prevent or slow the progression of cardiac complications. In the Molecular Imaging of Inflammation in Fabry Disease of the Heart study, the investigators will test the use of 68Ga-DOTATATE PET/MRI for identifying myocardial inflammation in patients with Fabry disease.
CONDITIONS
Official Title
Molecular Imaging in Fabry Disease of the Heart
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants over 18 years old
- Able to give written, informed consent and lie flat for scanning
- Have Fabry disease confirmed by molecular diagnosis (enzyme deficiency in males or pathogenic mutation in females)
- Have cardiac MRI within the last 3 years showing heart involvement (left ventricular hypertrophy, late gadolinium enhancement, or myocardial oedema)
You will not qualify if you...
- Any other diagnosis causing heart muscle inflammation, including myocarditis
- Previous gene therapy
- Contraindication to MRI or intravenous gadolinium contrast (prior reaction or kidney disease with eGFR less than 30 mL/min/1.73 m2)
- Women of childbearing potential not using adequate contraception
- Uncontrolled atrial fibrillation
- Any medical condition preventing lying flat during scanning or study participation, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cambridge University Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
Research Team
J
Jason M Tarkin, PhD MBBS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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