- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02887716
Mapping the Lumbar Spine Marrow Adiposity (FATFRAC)
August 30, 2016 updated by: University Hospital, Brest
The objective of this study is to describe the change in the percentage of fat in the lumbar spine.
Study Overview
Status
Completed
Conditions
Detailed Description
The study of the distribution of bone marrow adiposity is little known in subjects who did not have pathology likely to alter the fat content of the vertebrae.
Or that fat content is potentially a reflection of brittle bones (osteoporosis, for example), and deserves to be known because it can be used to normalize the lipid fraction values with respect to age or from the level (L1 , L2, L3, L4 or L5) of the vertebra being studied.
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brest, France, 26609
- CHRU de Brest
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who had an MRI of the lumbar spine in a context that justified (back pain, spondylitis research, radicular syndrome) having no corporeal spinal lesion at MRI examination.
Description
Inclusion Criteria:
- Consecutive patients who underwent MRI of the lumbar spine with Sagittal sequenceT1, T2 STIR and IDEAL, good quality, in a clinical setting type back pain, spondylitis research, radicular syndrome ...
- Examinations conducted between 2014 and 2015 on the same equipment
- Major patient
- Having formulated their non-opposition
Exclusion Criteria:
- Previous history of neoplastic disease
- Vertebral Fracture
- Pathology reaching the vertebral body detectable by MRI (disc lesion with rearrangements of the endplates (MODIC)
- Inflammation,
- Bone tumor,
- fracture
- Refusal of participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Value of the fat fraction by vertebral level of the lumbar spine, in MRI, measured on the mapping generated by the IDEAL-IQ sequence.
Time Frame: 3 months
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Douraied Ben Salem, Professor, CHRU de Brest
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
August 30, 2016
First Submitted That Met QC Criteria
August 30, 2016
First Posted (Estimate)
September 2, 2016
Study Record Updates
Last Update Posted (Estimate)
September 2, 2016
Last Update Submitted That Met QC Criteria
August 30, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FATFRAC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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