IDEAL PR: Compare Diagnostic Performance of DIXON &CHESS Sequences Calculating RAMRIS Score in Early Rheumatoid Arthritis.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)

Overall Status

Unknown status

CT.gov ID

NCT03943563

Collaborator

(none)

Enrollment

Location

Arm

43.6

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arthritis, Rheumatoid	Diagnostic Test: Dixon sequences acquisition	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention 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.

Primary Purpose:

Other

Official Title:

Comparison of Diagnostic Performance of DIXON Sequences With CHESS Sequences by Calculation of the RAMRIS Score in Early Rheumatoid Arthritis

Actual Study Start Date :

May 13, 2016

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: single cohort There is only one cohort where each patient experiment the "classic sequences" as the standard of care and the DIXON sequences for the study.	Diagnostic Test: Dixon sequences acquisition Dixon sequences acquisition

Arm

Intervention/Treatment

Other: single cohort

There is only one cohort where each patient experiment the "classic sequences" as the standard of care and the DIXON sequences for the study.

Diagnostic Test: Dixon sequences acquisition

Dixon sequences acquisition

Outcome Measures

Primary Outcome Measures

Ramris score [an average of 3 year]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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,...)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cliniques Universitaires Saint Luc	Bruxelles		Belgium	1200

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

ClinicalTrials.gov Identifier:

NCT03943563

Other Study ID Numbers:

Ideal PR
2016/24FEV/069

First Posted:

May 9, 2019

Last Update Posted:

Jul 12, 2019

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of Jul 12, 2019