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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058161
• Other study ID #: 2009-A01040-57
• Secondary ID: 2009 28
• Status: Completed
• Phase: N/A
• First received: January 27, 2010
• Last updated: August 27, 2014
• Start date: December 2009
• Est. completion date: February 2013

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abnormality
• Collagen Diseases
• Congenital Abnormalities
• Inflammation
• Rheumatic Diseases
• Rheumatism

Intervention

Other:
• high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
• high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
• high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
• high-field MRI (3 Teslas)
high-field MRI (3 Teslas)

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	can be obtained, one could expect an early detection of joint abnormalities		24 months	Yes
Secondary	will be to develop a quantitative analyse of the corresponding high-resolution images.		24 months	No