High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Assistance Publique Hopitaux De Marseille
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01058161
First received: January 27, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Abnormality Inflammation Rheumatism |
Other: high-field MRI (3 Teslas) |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms |
Further study details as provided by Assistance Publique Hopitaux De Marseille:
Primary Outcome Measures:
- can be obtained, one could expect an early detection of joint abnormalities [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- will be to develop a quantitative analyse of the corresponding high-resolution images. [ Time Frame: 24 months ]
| Estimated Enrollment: | 65 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Suspects or affected by rheumatoid polyarthritis |
Other: high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
|
| stiffening spondylitis with axial and peripheral infringement |
Other: high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
Other: high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
|
|
polyarthralgies with or without arthritis
Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis
|
Other: high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
Other: high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
|
| Healthy control |
Other: high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
Other: high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
|
|
not inflammatory control
Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control.
|
Other: high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
Other: high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058161
Contacts
| Contact: sandrine GUIS | sandrine.guis@ap-hm.fr |
Locations
| France | |
| Assistance Publique Hopitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: SANDRINE GUIS, PUPH | |
| Principal Investigator: SANDRINE GUIS | |
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
| Principal Investigator: | sandrine guis, PU PH | Assistance Publique Hopitaux De Marseille |
More Information
No publications provided
| Responsible Party: | Assistance Publique Hopitaux De Marseille, Assistance Publique Hopitaux De Marseille direction de la recherche |
| ClinicalTrials.gov Identifier: | NCT01058161 History of Changes |
| Other Study ID Numbers: | 2009-A01040-57, 2009 28 |
| Study First Received: | January 27, 2010 |
| Last Updated: | January 27, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Assistance Publique Hopitaux De Marseille:
|
wrist and hand cartilage abnormalities in inflammatory and chronic rheumatisms |
Additional relevant MeSH terms:
|
Congenital Abnormalities Inflammation Rheumatic Diseases |
Pathologic Processes Musculoskeletal Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on May 19, 2013