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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03943563
Other study ID # Ideal PR
Secondary ID 2016/24FEV/069
Status Completed
Phase N/A
First received
Last updated
Start date May 13, 2016
Est. completion date August 16, 2019

Study information

Verified date April 2024
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date August 16, 2019
Est. primary completion date August 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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,...)

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Dixon sequences acquisition
Dixon sequences acquisition

Locations

Country Name City State
Belgium Cliniques Universitaires Saint Luc Bruxelles

Sponsors (1)

Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
an average of 3 year
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