NCT01058161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

3.2 years

First QC Date

January 27, 2010

Last Update Submit

August 27, 2014

Conditions

Keywords

wrist and hand cartilage abnormalities in inflammatory and chronic rheumatisms

Outcome Measures

Primary Outcomes (1)

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

    24 months

Secondary Outcomes (1)

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

    24 months

Study Arms (5)

Suspects or affected by rheumatoid polyarthritis

OTHER
Other: high-field MRI (3 Teslas)

stiffening spondylitis with axial and peripheral infringement

OTHER
Other: high-field MRI (3 Teslas)

polyarthralgies with or without arthritis

OTHER

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)

Healthy control

OTHER
Other: high-field MRI (3 Teslas)

not inflammatory control

OTHER

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

Other: high-field MRI (3 Teslas)

Interventions

high-field MRI (3 Teslas)

Healthy controlSuspects or affected by rheumatoid polyarthritisnot inflammatory controlpolyarthralgies with or without arthritisstiffening spondylitis with axial and peripheral infringement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Claustrophobia,
  • metallic foreign bodies,
  • pacemakers The pregnant women,
  • parturients or who breast-feed are excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Congenital AbnormalitiesInflammationRheumatic Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • sandrine guis, PU PH

    Assistance Publique Hopitaux De Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2010

First Posted

January 28, 2010

Study Start

December 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations