Using T1 mapping to assess Fabry disease
T1 Mapping in Diagnosis and Follow up of Fabry Disease
This study is testing if a special MRI technique can help doctors better understand kidney problems in people with Fabry disease and improve their treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 2 sites (Bron and 1 other locations) |
| Trial ID | NCT05923788 on ClinicalTrials.gov |
What this trial studies
This study focuses on Fabry disease, a lysosomal storage disorder that leads to organ dysfunction, particularly affecting the kidneys, heart, and cerebrovascular system. It aims to utilize T1 mapping through functional MRI to evaluate the severity of nephropathy in patients with Fabry disease. The study will include both confirmed Fabry patients and control patients undergoing renal assessments for other conditions. The goal is to address challenges in treatment initiation and monitoring for Fabry nephropathy, especially in non-classic phenotype patients.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed Fabry disease or those undergoing renal functional exploration for other reasons.
Not a fit: Patients with conditions such as kidney transplant, polycystic kidney disease, or contraindications to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the monitoring and management of Fabry disease, leading to better patient outcomes.
How similar studies have performed: While T1 mapping has shown promise in assessing cardiac involvement in Fabry disease, this specific application in nephropathy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with confirmed Fabry disease Or Control patients: Patients undergoing renal functional exploration for a reason other than Fabry disease, amyloidosis, hemochromatosis * Adult patient * Patient informed of the study and agree to participate * Patient affiliated to a social security or beneficiaries of a similar scheme Exclusion Criteria: * Weight \> 130 kg * kidney transplant, * polycystic kidney disease, * Pregnant, parturient or breastfeeding * Contraindications to MRI * Subject participating in another research including an exclusion period still in progress at inclusion * Persons deprived of their liberty by a judicial or administrative decision, * Adults subject to a legal protection measure (safeguard measure, guardianship, curators)
Where this trial is running
Bron and 1 other locations
- Hopital Femme Mère Enfant — Bron, France (Not_yet_recruiting)
- Hopital Edouard Herriot — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Sandrine Lemoine, Pu-Ph
- Email: sandrine.lemoine01@chu-lyon.fr
- Phone: 04 72 11 02 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.