Search / Trial NCT06226987

Molecular Imaging in Fabry Disease of the Heart

Launched by UNIVERSITY OF CAMBRIDGE · Jan 17, 2024

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

ClinConnect Summary

The clinical trial titled "Molecular Imaging in Fabry Disease of the Heart" is studying a new imaging method to help identify heart inflammation in people with Fabry disease. Fabry disease is a genetic condition that can affect various parts of the body, including the heart. The researchers want to see if a special type of scan called 68Ga-DOTATATE PET/MRI can help detect early signs of heart problems, which could lead to better treatment options and help prevent further complications.

To participate in this trial, individuals must be at least 18 years old and have a confirmed diagnosis of Fabry disease. They should have had a heart MRI in the past three years showing signs of heart involvement, like thickening of the heart muscle. Participants will need to lie flat during the imaging process and be able to give their consent to join the study. It’s important to note that people with certain other heart conditions or those who have had previous treatments that could interfere with the results may not be eligible. If you decide to participate, you will be contributing to important research that aims to improve the care for those living with Fabry disease.

Gender

ALL

Eligibility criteria

  • 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

About University Of Cambridge

The University of Cambridge, a prestigious institution renowned for its commitment to research excellence and innovation, serves as a clinical trial sponsor dedicated to advancing medical science and improving patient outcomes. Leveraging its interdisciplinary expertise and state-of-the-art facilities, the university conducts rigorous clinical trials that explore novel therapies and interventions across a wide range of health conditions. By fostering collaboration between researchers, healthcare professionals, and industry partners, the University of Cambridge aims to translate groundbreaking research into effective clinical applications, ultimately enhancing the quality of care and contributing to the global medical community.

Locations

Cambridge, Cambridgeshire, United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0