Diagnostic Performance of 18-FDG PET-CT Scores for the Diagnosis of Polymyalgia Rheumatica (RHUMATEP)

August 19, 2024 updated by: University Hospital, Brest

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Brest, France, 29609
        • CHU Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult with inflammatory rheumatism confirmed by specialist, with or without treatment and having a 18-FDG-PET CT.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Refusal participation
  • Patient under juridic protection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of SUV and visual fixation of mains joints.
Time Frame: up to 9 months
Measure of SUV of mains joints and evaluation of the fixation compared to liver.
up to 9 months
Diagnostic performance of 18-FDG PET scores for diagnostic of others inflammatory rheumatism.
Time Frame: up to 9 months
Evaluation of the precedent scores for diagnosis of others rheumatisms. Creation of others scores if some joints seem to be interesting.
up to 9 months
Comparaison of scores with clinical, biological and radiological data.
Time Frame: up to 9 months
Search for correlation between scores and symptoms, blood test or CT/MRI exams.
up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Study Director: Solène QUERELLOU, CHU Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC24.0172 - RHUMATEP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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