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

NCT03943563 | Completed

• 2 other identifiers: Ideal PR2016/24FEV/069
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

single cohort

OTHER

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

Interventions

Dixon sequences acquisition DIAGNOSTIC_TEST

Dixon sequences acquisition

single cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Rheumatoid arthritis diagnosis for less than 3 years

You may not qualify if:

• contraindication to Dotarem contrast injection
• contraindication to MRI due to incompatible implanted material (peacemaker, prosthesis,...)

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: None at the time of intervention. At the end of the study, Blind reading without knowledge of the type: Dixon or "classic" sequences.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: May 9, 2019
• Study Start: May 13, 2016
• Primary Completion: August 16, 2019
• Study Completion: August 16, 2019
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

BE (1)