Molecular Imaging in Fabry Disease of the Heart
ConditionFabry Disease, Cardiac Variant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Cambridge
About this trial
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.
Eligibility criteria
Qualifiers
Male or female participants >18 years old
Able to give written, informed consent and to lie flat
Have Fabry disease based on molecular diagnosis (at a minimum, documented enzyme deficiency in males and documented pathogenic mutation in females)
Cardiac MRI within 3 years documenting cardiac involvement in Fabry disease (left ventricular hypertrophy and/or late gadolinium enhancement and/or myocardial oedema)
Disqualifiers
Any other diagnosis associated with cardiac muscle inflammation, including myocarditis
Previous gene therapy
Contra-indication to MRI scanning or intravenous gadolinium contrast (prior contrast reaction or chronic kidney disease with eGFR <30 mL/min/1.73 m2)
Women of child bearing potential not using adequate contraception
Trial design
Treatments tested in this trial
- 68Ga-DOTATATE PET/MRI
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Cambridge
Lead sponsor
Sanofi
Collaborator
Source ClinicalTrials.gov