RECRUITINGOBSERVATIONAL
Molecular Imaging in Fabry Disease of the Heart
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Male or female participants \>18 years old
- Able to give written, willing to sign a consent form 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)
Who Should NOT Join This Trial:
- 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
- Uncontrolled atrial fibrillation
- Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* Uncontrolled atrial fibrillation
* Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study
Treatments Being Tested
DIAGNOSTIC_TEST
68Ga-DOTATATE PET/MRI
PET/MRI scanning
Locations (1)
Cambridge University Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom