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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02887716
Other study ID # FATFRAC
Secondary ID
Status Completed
Phase N/A
First received August 30, 2016
Last updated August 30, 2016
Start date August 2015
Est. completion date November 2015

Study information

Verified date August 2016
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority France: The Commission nationale de l’informatique et des libertés
Study type Observational

Clinical Trial Summary

The objective of this study is to describe the change in the percentage of fat in the lumbar spine.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Value of the fat fraction by vertebral level of the lumbar spine, in MRI, measured on the mapping generated by the IDEAL-IQ sequence. 3 months No