Arthritis, RheumatoidIDEAL PRNCT03943563
Compare Diagnostic Performance of DIXON &CHESS Sequences Calculating RAMRIS Score in Early Rheumatoid Arthritis.
A study testing Dixon sequences acquisition in people with Arthritis, Rheumatoid, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Dixon sequences acquisition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 13 May 2016to 16 Aug 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Rheumatoid arthritis diagnosis for less than 3 years
Who cannot join
- contraindication to Dotarem contrast injection
- contraindication to MRI due to incompatible implanted material (peacemaker, prosthesis,...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Diagnostic Performance of DIXON Sequences With CHESS Sequences by Calculation of the RAMRIS Score in Early Rheumatoid Arthritis
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.
Read the 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Dixon sequences acquisition
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dixon sequences acquisitionDiagnostic test
Dixon sequences acquisition
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Dixon sequences acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start13 May 2016
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943563
- Sponsor's protocol ID
- Ideal PR
- Other IDs
- 2016/24FEV/069
- Acronym
- IDEAL PR
- Status last verified
- Apr 2024
- First submitted
- 19 Mar 2019
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diagnostic Performance of DIXON Sequences With CHESS Sequences by Calculation of the RAMRIS Score in Early Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03943563
- Acronym / sponsor ID
- IDEAL PR / Ideal PR
- Conditions
- Arthritis, Rheumatoid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 13 May 2016 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 9 May 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single cohort | Other | Diagnostic Test: Dixon sequences acquisitionThere is only one cohort where each patient experiment the "classic sequences" as the standard of care and the DIXON sequences for the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- - Rheumatoid arthritis diagnosis for less than 3 years
Key exclusion criteria (2 listed)
- contraindication to Dotarem contrast injection
- contraindication to MRI due to incompatible implanted material (peacemaker, prosthesis,...)
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 |
|---|---|---|
| Dixon sequences acquisitionDixon sequences acquisition | Diagnostic test | single cohort |
Primary outcome
Ramris score
Time frame: 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
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 10 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dixon sequences acquisition in people with Arthritis, Rheumatoid, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 2 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 10 Apr 2024. 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 Belgium. 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?
Ramris score (time frame: an average of 3 year). 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 10 Apr 2024.