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

Primary Purpose

Abnormality, Inflammation, Rheumatism

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
high-field MRI (3 Teslas)
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abnormality focused on measuring wrist and hand cartilage abnormalities in inflammatory and chronic rheumatisms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

Suspects or affected by rheumatoid polyarthritis

stiffening spondylitis with axial and peripheral infringement

polyarthralgies with or without arthritis

Healthy control

not inflammatory control

Arm Description

Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis

Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control.

Outcomes

Primary Outcome Measures

can be obtained, one could expect an early detection of joint abnormalities

Secondary Outcome Measures

will be to develop a quantitative analyse of the corresponding high-resolution images.

Full Information

First Posted
January 27, 2010
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01058161
Brief Title
High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms
Official Title
High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormality, Inflammation, Rheumatism
Keywords
wrist and hand cartilage abnormalities in inflammatory and chronic rheumatisms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Suspects or affected by rheumatoid polyarthritis
Arm Type
Other
Arm Title
stiffening spondylitis with axial and peripheral infringement
Arm Type
Other
Arm Title
polyarthralgies with or without arthritis
Arm Type
Other
Arm Description
Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis
Arm Title
Healthy control
Arm Type
Other
Arm Title
not inflammatory control
Arm Type
Other
Arm Description
Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control.
Intervention Type
Other
Intervention Name(s)
high-field MRI (3 Teslas)
Intervention Description
high-field MRI (3 Teslas)
Intervention Type
Other
Intervention Name(s)
high-field MRI (3 Teslas)
Intervention Description
high-field MRI (3 Teslas)
Intervention Type
Other
Intervention Name(s)
high-field MRI (3 Teslas)
Intervention Description
high-field MRI (3 Teslas)
Intervention Type
Other
Intervention Name(s)
high-field MRI (3 Teslas)
Intervention Description
high-field MRI (3 Teslas)
Primary Outcome Measure Information:
Title
can be obtained, one could expect an early detection of joint abnormalities
Time Frame
24 months
Secondary Outcome Measure Information:
Title
will be to develop a quantitative analyse of the corresponding high-resolution images.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sandrine guis, PU PH
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

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

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