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High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01058161
First received: January 27, 2010
Last updated: August 27, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: December 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (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

    1. Morning articular Stiffness of at least 15 minutes.
    2. Arthalgias or Arthritises of at least three joints(articulations), among which those of the hand.
    3. Possible rheumatoid Presence of a factor(mailman) and\or Antibody anti peptides positive citrullinés.
    4. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058161

Locations
France
Assistance Publique Hopitaux de Marseille
Marseille, France
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
ClinicalTrials.gov Identifier: NCT01058161     History of Changes
Other Study ID Numbers: 2009-A01040-57, 2009 28
Study First Received: January 27, 2010
Last Updated: August 27, 2014
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
Connective Tissue Diseases
Musculoskeletal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014