Giant Cell Arteritis - Optimization of Diagnostics (GAME)

March 27, 2025 updated by: Steffen Hamann, Rigshospitalet, Denmark

Giant Cell Arteritis - Examination of the Optimal Diagnostic Pathway

Giant cell arteritis - Optimization of diagnostics

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective study. Investigating the use of ultrasound, temporal artery biopsy, biomarkers and 18F-fluorodeoxyglucose positron emission tomography-computed tomography for establishing a diagnosis of giant cell (temporal) arteritis.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

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

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Rigshospitalet

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Clinical suspicion of giant cell arteritis

Description

Inclusion Criteria:

Clinical suspicion of giant cell arteritis

Meets the American College of Rheumatology Criteria:

Age at disease onset => 50 years New headache Temporal artery abnormality Elevated erythrocyte sedimentation rate >=50 mm/hour Abnomal artery biopsy

Exclusion Criteria:

Active cancer Use of steroid for more than a week (the prior 6 months)

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Giant cell arteritis
Time Frame: Week 26
Clinical verification of giant cell arteritis diagnosis as evaluated with a combination of ultrasound, biopsy and PET/CT.
Week 26

Collaborators and Investigators

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

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Steffen Hamann, MD, PhD,FEBO, Rigshospitalet, Denmark

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 (Actual)

March 19, 2021

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20032069

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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