Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01671865 |
Recruitment Status
:
Recruiting
First Posted
: August 24, 2012
Last Update Posted
: April 5, 2018
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Condition or disease |
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Facioscapulohumeral Muscular Dystrophy |
Study Type : | Observational |
Estimated Enrollment : | 75 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Magnetic Resonance Imaging and Spectroscopy Biomarkers for Facioscapulohumeral Muscular Dystrophy |
Actual Study Start Date : | March 2012 |
Estimated Primary Completion Date : | June 2020 |
Estimated Study Completion Date : | June 2020 |

- Intramuscular fat infiltration on MRI [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]Intramuscular fat infiltration on MRI
- Intramuscular edema on MRI [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]Intramuscular edema on MRI
- Muscle strength testing [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]Muscle strength testing
- Timed function testing [ Time Frame: Baseline, 3 months, 9 months, 15 months, and 21 months ]Timed function testing

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Ability to give written informed consent for study participation (a parent or guardian will be asked to provide informed consent for participants younger than 18 years old)
- Confirmed diagnosis of FSHD through genetic testing (participants will be asked to provide copies of genetic testing results)
Exclusion Criteria:
- Any contraindication to MRI scanning
- Inability to complete a physical examination, including strength measurements

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671865
Contact: Doris G Leung, MD, PhD | 443-923-9521 | leungd@kennedykrieger.org |
United States, Maryland | |
Doris Leung | Recruiting |
Baltimore, Maryland, United States, 21205 | |
Contact: Doris G Leung, MD, PhD 443-923-9521 leungd@kennedykrieger.org | |
Principal Investigator: Doris G Leung, MD, PhD |
Principal Investigator: | Doris G Leung, MD, PhD | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
Additional Information:
Publications of Results:
Other Publications:
Responsible Party: | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. |
ClinicalTrials.gov Identifier: | NCT01671865 History of Changes |
Other Study ID Numbers: |
NA_00065256 |
First Posted: | August 24, 2012 Key Record Dates |
Last Update Posted: | April 5, 2018 |
Last Verified: | April 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:
FSHD magnetic resonance imaging magnetic resonance spectroscopy |
Additional relevant MeSH terms:
Muscular Dystrophies Muscular Dystrophy, Facioscapulohumeral Muscular Disorders, Atrophic Muscular Diseases |
Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Genetic Diseases, Inborn |