- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01058161
High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms
August 27, 2014 updated by: Assistance Publique Hopitaux De Marseille
The present project aims at evaluating the diagnostic potential of high-field MRI (3 Teslas) for joint disease.
At this field, given that isotropic image resolution of 400 microns can be obtained, one could expect an early detection of joint abnormalities.
The additional aim of this project will be to develop a quantitative analyse of the corresponding high-resolution images.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
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
-
-
-
Marseille, France
- Assistance Publique Hopitaux de Marseille
-
-
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
gp Suspects or affected by rheumatoid polyarthritis
- Morning articular Stiffness of at least 15 minutes.
- Arthalgias or Arthritises of at least three joints(articulations), among which those of the hand.
- Possible rheumatoid Presence of a factor(mailman) and\or Antibody anti peptides positive citrullinés.
- Typical possible radiological Hurts on the standard clichés(pictures) of the reached(affected) joints(articulations).
gp Affected by stiffening spondylitis with axial and peripheral infringement :
. Lumbago and steepness lumbar vertebra inflammatory. 2. Arthralgias and\or peripheral arthritises 3. Possible presence of an allèle HLA 4. Possible presence of a sacro-illite 5. Absence of the other rheumatic markers
- gp Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis
- gp Healthy control
- gp Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control.
Exclusion Criteria:
- Claustrophobia,
- metallic foreign bodies,
- pacemakers The pregnant women,
- parturients or who breast-feed are excluded from the study
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
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Suspects or affected by rheumatoid polyarthritis
|
high-field MRI (3 Teslas)
|
|
Other: stiffening spondylitis with axial and peripheral infringement
|
high-field MRI (3 Teslas)
|
|
Other: polyarthralgies with or without arthritis
Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis
|
high-field MRI (3 Teslas)
|
|
Other: Healthy control
|
high-field MRI (3 Teslas)
|
|
Other: not inflammatory control
Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control.
|
high-field MRI (3 Teslas)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
can be obtained, one could expect an early detection of joint abnormalities
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
will be to develop a quantitative analyse of the corresponding high-resolution images.
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: sandrine guis, PU PH, Assistance Publique Hopitaux de Marseille
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
December 1, 2009
Primary Completion (Actual)
February 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
January 27, 2010
First Submitted That Met QC Criteria
January 27, 2010
First Posted (Estimate)
January 28, 2010
Study Record Updates
Last Update Posted (Estimate)
August 28, 2014
Last Update Submitted That Met QC Criteria
August 27, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-A01040-57
- 2009 28 (Other Identifier: 2009 28)
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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