NCT06558357

Brief Summary

Study of the diagnostic performance of 18-FDG PET scores in Polymyalgia rheumatica and comparaison with others inflammatories diseases.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 20, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

August 13, 2024

Last Update Submit

August 19, 2024

Conditions

Keywords

Polymyalgia rheumaticaFDGPETDiagnostic performancescore

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 9 months

Secondary Outcomes (3)

  • Analysis of SUV and visual fixation of mains joints.

    up to 9 months

  • Diagnostic performance of 18-FDG PET scores for diagnostic of others inflammatory rheumatism.

    up to 9 months

  • Comparaison of scores with clinical, biological and radiological data.

    up to 9 months

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Refusal participation
  • Patient under juridic protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Rheumatic FeverPolymyalgia Rheumatica

Condition Hierarchy (Ancestors)

Streptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesMuscular Diseases

Study Officials

  • Solène QUERELLOU

    CHU Brest

    STUDY DIRECTOR

Central Study Contacts

Chloé QUERE

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 16, 2024

Study Start

September 1, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

August 20, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending fifteen years following the final study report completion
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

Locations