Marrow Adiposity Lumbar SpineFATFRACNCT02887716
Mapping the Lumbar Spine Marrow Adiposity
An observational study of Marrow Adiposity Lumbar Spine, run by University Hospital, Brest at 1 site in France.
Trial summary
The objective of this study is to describe the change in the percentage of fat in the lumbar spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marrow Adiposity Lumbar Spine
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to describe the change in the percentage of fat in the lumbar spine.
Read the 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.
- Conditions
- Marrow Adiposity Lumbar Spine
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of the fat fraction by vertebral level of the lumbar spine, in MRI, measured on the mapping generated by the IDEAL-IQ sequence.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marrow Adiposity Lumbar SpineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douraied Ben Salem, Professor, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887716
- Sponsor's protocol ID
- FATFRAC
- Acronym
- FATFRAC
- Status last verified
- Aug 2016
- First submitted
- 30 Aug 2016
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping the Lumbar Spine Marrow Adiposity
- ClinicalTrials.gov ID
- NCT02887716
- Acronym / sponsor ID
- FATFRAC / FATFRAC
- Conditions
- Marrow Adiposity Lumbar Spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to describe the change in the percentage of fat in the lumbar spine.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douraied Ben Salem, Professor principal investigator
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Marrow Adiposity Lumbar Spine, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016; AzTrials last refreshed its copy on 31 Oct 2026.