AbnormalityNCT01058161
High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms
A study testing high-field MRI (3 Teslas) in people with Abnormality and Inflammation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abnormality, Inflammation, Rheumatism
- What is being tested?
- high-field MRI (3 Teslas)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
Show all 10Show fewer
- . 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.
Who cannot join
- Claustrophobia,
- metallic foreign bodies,
- pacemakers The pregnant women,
- parturients or who breast-feed are excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Abnormality, Inflammation, Rheumatism
- Being tested
- high-field MRI (3 Teslas)
- Keywords
- wrist and hand cartilage abnormalities in inflammatory and chronic rheumatisms
- Medical subject headings
- Congenital Abnormalities, Inflammation, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-field MRI (3 Teslas)Other
high-field MRI (3 Teslas)
high-field MRI (3 Teslas)Other
high-field MRI (3 Teslas)
high-field MRI (3 Teslas)Other
high-field MRI (3 Teslas)
high-field MRI (3 Teslas)Other
high-field MRI (3 Teslas)
| Study group | Role | What they receive |
|---|---|---|
| Suspects or affected by rheumatoid polyarthritis | Other | Not described Receives: Other: high-field MRI (3 Teslas) |
| stiffening spondylitis with axial and peripheral infringement | Other | Not described Receives: 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 Receives: Other: high-field MRI (3 Teslas) |
| Healthy control | Other | Not described Receives: 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. Receives: Other: high-field MRI (3 Teslas) |
What is being measured
The primary outcome is the main question the study is designed to answer.
can be obtained, one could expect an early detection of joint abnormalities
Measured: 24 months
Secondary outcomes (1)
will be to develop a quantitative analyse of the corresponding high-resolution images.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbnormalityStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- sandrine guis, PU PH, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058161
- Sponsor's protocol ID
- 2009-A01040-57
- Other IDs
- 2009 28
- Status last verified
- Aug 2014
- First submitted
- 27 Jan 2010
- Last updated
- 28 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic Rheumatisms
- ClinicalTrials.gov ID
- NCT01058161
- Acronym / sponsor ID
- 2009-A01040-57
- Conditions
- Abnormality, Inflammation, Rheumatism
- Keywords
- wrist and hand cartilage abnormalities in inflammatory and chronic rheumatisms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 28 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: high-field MRI (3 Teslas)Affected by connectivity with anti-nuclear antibody positive and / or specific antibodies, suffering of polyarthralgias with or without arthritis |
| Healthy control | Other | Other: high-field MRI (3 Teslas) |
| not inflammatory control | Other | Other: high-field MRI (3 Teslas)Presenting a degenerative osteoarthritis of the wrist traumatic comment, noticed radiologically, which will serve as not inflammatory control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- gp Suspects or affected by rheumatoid polyarthritis
- 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
Key exclusion criteria (4 listed)
- Claustrophobia,
- metallic foreign bodies,
- pacemakers The pregnant women,
- parturients or who breast-feed are excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-field MRI (3 Teslas)high-field MRI (3 Teslas) | Other | Healthy control, Suspects or affected by rheumatoid polyarthritis, not inflammatory control, polyarthralgies with or without arthritis, stiffening spondylitis with axial and peripheral infringement |
| high-field MRI (3 Teslas)high-field MRI (3 Teslas) | Other | stiffening spondylitis with axial and peripheral infringement |
| high-field MRI (3 Teslas)high-field MRI (3 Teslas) | Other | polyarthralgies with or without arthritis |
| high-field MRI (3 Teslas)high-field MRI (3 Teslas) | Other | Healthy control, not inflammatory control |
Primary outcome
can be obtained, one could expect an early detection of joint abnormalities
Time frame: 24 months
1 secondary outcome
will be to develop a quantitative analyse of the corresponding high-resolution images.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2014.
Related trials for Abnormality
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingObservational study
Genome Medical Sequencing for Gene Discovery
Intellectual Disabilities, Congenital Anomaly
Recruiting
Contribution of Optical Genome Mapping (OGM) in the Diagnosis of Multiple Congenital Malformations With or Without Intellectual Disability Without Genetic Abnormality
Congenital Malformations
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Recruiting
Early Detection of Developmental Abnormalities of Preterm Infants at 5 Years of Age
5 Year Old Children Born Prematurely
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sandrine guis, PU PH principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-field MRI (3 Teslas) in people with Abnormality and Inflammation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
can be obtained, one could expect an early detection of joint abnormalities (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2014.