Compare Diagnostic Performance of DIXON &CHESS Sequences Calculating RAMRIS Score in Early Rheumatoid Arthritis. (IDEAL PR)
Primary Purpose
Arthritis, Rheumatoid
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Dixon sequences acquisition
Sponsored by
About this trial
This is an interventional other trial for Arthritis, Rheumatoid
Eligibility Criteria
Inclusion Criteria:
- - Rheumatoid arthritis diagnosis for less than 3 years
Exclusion Criteria:
- contraindication to Dotarem contrast injection
- contraindication to MRI due to incompatible implanted material (peacemaker, prosthesis,...)
Sites / Locations
- Cliniques Universitaires Saint LucRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
single cohort
Arm Description
There is only one cohort where each patient experiment the "classic sequences" as the standard of care and the DIXON sequences for the study.
Outcomes
Primary Outcome Measures
Ramris score
Calculation of the Rheumatoid Arthritis MRI Scoring System (RAMRIS score) for each sequence by two independent radiologists. RAMRIS is used to evaluate erosions (scale, 0-10, 10 representing the worst situation), edema (scale, 0-3, 3 representing the worst situation), and synovitis (scale, 0-3, 3 representing the worst situation)
Blind reading without knowledge of the type of Dixon or "classic" sequence
Secondary Outcome Measures
Full Information
NCT ID
NCT03943563
First Posted
March 19, 2019
Last Updated
July 11, 2019
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT03943563
Brief Title
Compare Diagnostic Performance of DIXON &CHESS Sequences Calculating RAMRIS Score in Early Rheumatoid Arthritis.
Acronym
IDEAL PR
Official Title
Comparison of Diagnostic Performance of DIXON Sequences With CHESS Sequences by Calculation of the RAMRIS Score in Early Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 13, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In a preliminary MRI study of healthy volunteers's hands investigators showed that the suppression of the fat signal obtained by the Dixon sequences is greater than that obtained by the "classic" CHESS sequences with a better T1-weighted image quality. The investigators goal now is to compare these sequences in the quantification of the inflammatory activity of rheumatoid arthritis by the RAMRIS score. To investigators knowledge, only one study compared those two types of sequence with many limitations including a limited number of patients included.
Detailed Description
Rheumatoid arthritis (RA) is the most common chronic inflammatory arthropathy and it mostly affect young women. The MRI sequences currently validated for the joint inflammation assessment are the fat-suppressed sequences produced either by spectral presaturation (CHESS sequences) or by inversion-recovery (STIR = short tau inversion recovery sequence). The presaturation sequences outweigh the STIR sequence due to higher spatial resolution at the expense of sometimes more random saturation of the fat signal. Recently, a third method of suppressing the fat signal (Dixon method) has reappeared thanks to advances in computing power (post-processing). In a preliminary MRI study of the hands of healthy volunteers, the investigators showed that the suppression of the fat signal obtained by the Dixon sequences is greater than that obtained by the "classic" CHESS sequences in T1 and T2 weighting with better quality. image in T1 weighting. This increased performance, particularly in terms of fat suppression, could lead to better detection of PR lesions on MRI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
None at the time of intervention. At the end of the study, Blind reading without knowledge of the type: Dixon or "classic" sequences.
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single cohort
Arm Type
Other
Arm Description
There is only one cohort where each patient experiment the "classic sequences" as the standard of care and the DIXON sequences for the study.
Intervention Type
Diagnostic Test
Intervention Name(s)
Dixon sequences acquisition
Intervention Description
Dixon sequences acquisition
Primary Outcome Measure Information:
Title
Ramris score
Description
Calculation of the Rheumatoid Arthritis MRI Scoring System (RAMRIS score) for each sequence by two independent radiologists. RAMRIS is used to evaluate erosions (scale, 0-10, 10 representing the worst situation), edema (scale, 0-3, 3 representing the worst situation), and synovitis (scale, 0-3, 3 representing the worst situation)
Blind reading without knowledge of the type of Dixon or "classic" sequence
Time Frame
an average of 3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid arthritis diagnosis for less than 3 years
Exclusion Criteria:
contraindication to Dotarem contrast injection
contraindication to MRI due to incompatible implanted material (peacemaker, prosthesis,...)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Kirchgesner, PhD Student
Phone
+32(0)27648087
Email
thomas.kirchgesner@uclouvain.be
Facility Information:
Facility Name
Cliniques Universitaires Saint Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perrine Triqueneaux, Msc
Phone
+32(2)7642935
Email
perrine.triqueneaux@uclouvain.be
12. IPD Sharing Statement
Learn more about this trial
Compare Diagnostic Performance of DIXON &CHESS Sequences Calculating RAMRIS Score in Early Rheumatoid Arthritis.
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