Inflammatory RheumatismRHUMATEPNCT06558357
Diagnostic Performance of 18-FDG PET-CT Scores for the Diagnosis of Polymyalgia Rheumatica
An observational study of Inflammatory Rheumatism and 18-FDG, run by University Hospital, Brest at 1 site in France.
Trial summary
Study of the diagnostic performance of 18-FDG PET scores in Polymyalgia rheumatica and comparaison with others inflammatories diseases. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Inflammatory Rheumatism, 18-FDG, Positron-emission Tomography
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2024to 31 Dec 2024
- Phase
- Observational
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult with inflammatory rheumatism confirmed by specialist, with or without treatment and having a 18-FDG-PET CT.
Who may be able to join
- Having 18-FDG PET-CT between 2012 and 2024
- Diagnosis of inflammatory rheumatism by specialist doctor
- Adult without opposition to use there data for research
- Affiliate to social security system
Who cannot join
- Refusal participation
- Patient under juridic protection
Trial locations and contacts
1 site in 1 country.
Chloé QUERE contact
About this study
Official title: Evaluation of the Diagnostic Performance of 18-FDG PET-CT Scores for the Diagnosis of Polymyalgia Rheumatica and Comparison With Others Inflammatory Rheumatic Diseases.
Study of the diagnostic performance of 18-FDG PET scores in Polymyalgia rheumatica and comparaison with others inflammatories diseases.
Read the detailed description
Polymyalgia Rheumatica is difficult to diagnostic because symptoms are non specific and many diseases can be differential diagnosis (cancer, infections, others rheumatisms...).
PET-CT is more often used to help for diagnostic of inflammatory disease, and particularly inflammatory rheumatism.
Some scores have been described to harmonize the diagnosis of Polymyalgia rheumatica.
The aim of this study is to evaluate the diagnostic performance of 18-FDG PET scores in Polymyalgia rheumatica and compared with others inflammatories diseases such as ankylosing spondylarthritis.
This is a multicentric retrospective study.
- Keywords
- Polymyalgia rheumatica, FDG, PET, Diagnostic performance, score
- Medical subject headings
- Rheumatic Fever, Polymyalgia Rheumatica
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of 18-FDG PET scores for diagnostic of Polymyalgia rheumatica.
Evaluation of the metabolism of mains joints compared to liver. Calculation of different scores described in literature.
Measured: up to 9 months
Secondary outcomes (3)
Analysis of SUV and visual fixation of mains joints.
Measure of SUV of mains joints and evaluation of the fixation compared to liver.
Measured: up to 9 months
Diagnostic performance of 18-FDG PET scores for diagnostic of others inflammatory rheumatism.
Evaluation of the precedent scores for diagnosis of others rheumatisms. Creation of others scores if some joints seem to be interesting.
Measured: up to 9 months
Comparaison of scores with clinical, biological and radiological data.
Search for correlation between scores and symptoms, blood test or CT/MRI exams.
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory RheumatismStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Solène QUERELLOU, Study director, CHU Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558357
- Sponsor's protocol ID
- 29BRC24.0172 - RHUMATEP
- Acronym
- RHUMATEP
- Status last verified
- Jun 2024
- First submitted
- 13 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic Performance of 18-FDG PET-CT Scores for the Diagnosis of Polymyalgia Rheumatica and Comparison With Others Inflammatory Rheumatic Diseases.
- ClinicalTrials.gov ID
- NCT06558357
- Acronym / sponsor ID
- RHUMATEP / 29BRC24.0172 - RHUMATEP
- Keywords
- Polymyalgia rheumatica, FDG, PET, Diagnostic performance, score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Aug 2024 (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.
Study of the diagnostic performance of 18-FDG PET scores in Polymyalgia rheumatica and comparaison with others inflammatories diseases.
Detailed description
Polymyalgia Rheumatica is difficult to diagnostic because symptoms are non specific and many diseases can be differential diagnosis (cancer, infections, others rheumatisms...).
PET-CT is more often used to help for diagnostic of inflammatory disease, and particularly inflammatory rheumatism.
Some scores have been described to harmonize the diagnosis of Polymyalgia rheumatica.
The aim of this study is to evaluate the diagnostic performance of 18-FDG PET scores in Polymyalgia rheumatica and compared with others inflammatories diseases such as ankylosing spondylarthritis.
This is a multicentric retrospective study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult with inflammatory rheumatism confirmed by specialist, with or without treatment and having a 18-FDG-PET CT.
Key inclusion criteria (4 listed)
- Having 18-FDG PET-CT between 2012 and 2024
- Diagnosis of inflammatory rheumatism by specialist doctor
- Adult without opposition to use there data for research
- Affiliate to social security system
Key exclusion criteria (2 listed)
- Refusal participation
- Patient under juridic protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic performance of 18-FDG PET scores for diagnostic of Polymyalgia rheumatica.
Time frame: up to 9 months
Evaluation of the metabolism of mains joints compared to liver. Calculation of different scores described in literature.
3 secondary outcomes
Analysis of SUV and visual fixation of mains joints.
Time frame: up to 9 months
Diagnostic performance of 18-FDG PET scores for diagnostic of others inflammatory rheumatism.
Time frame: up to 9 months
Comparaison of scores with clinical, biological and radiological data.
Time frame: up to 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Chloé QUERE contact
Solène QUERELLOU study director
CHU Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Rheumatism and 18-FDG, run by University Hospital, Brest at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 20 Aug 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Solène QUERELLOU (0298223080 ext. +33, solene.querellou@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of 18-FDG PET scores for diagnostic of Polymyalgia rheumatica. (time frame: up to 9 months). 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 20 Aug 2024.