CrCest Study in Primary Mitochondrial Disease
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Children's Hospital of Philadelphia
- Study ID
- NCT04734626
- Status
- Enrolling By Invitation
Conditions
- Mitochondrial Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 7 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Creatine Chemical Exchange Saturation Transfer (CrCEST) Imaging Sequence — DIAGNOSTIC_TESTCrCEST be used to assess creatine distribution and concentrations in muscle (lower extremity), both at rest and after recovery from a brief foot-pedal depression exercise
Study Details
The purpose of this study is to perform a "muscle phenotyping" magnetic resonance imaging (MRI) assessment in patients receiving clinical care at the Children's Hospital of Philadelphia (CHOP) for mitochondrial disease that is either suspected (based on clinical presentation) or has a definite genetic diagnosis. The MRI assessment quantifies skeletal muscle oxidative phosphorylation (OXPHOS) capacity. Investigators hope that this study will contribute to our current knowledge of mitochondrial diseases and this study will help create a new diagnostic tool for use in both clinical care and in clinical trials.
Key Dates
- Start date
- May 25, 2021
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 230 participants (estimated)
Arms
- Arm: Mitochondrial DiseaseIndividuals with suspected (based on clinical presentation) or definite genetic mitochondrial disease
- Arm: Healthy Controls/VolunteersIndividuals with no history of suspected (based on clinical presentation) or definite genetic mitochondrial disease
Primary Outcome Measure
Post-exercise CrCEST recovery time (seconds) [ Time Frame: During the MRI ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | - |
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