Giant Cell Arteritis - Optimization of Diagnostics | NCT05248906

Studies
Giant Cell Arteritis - Optimization of Diagnostics

NCT05248906

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Apr 2, 2025Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Giant Cell Arteritis

Interventions

Giant cell arteritis

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2021Actual

Primary Completion Date

Jan 1, 2024Actual

Completion Date

Jan 1, 2024Actual

First Submitted Date

Nov 3, 2020

First Submission Date that Met QC Criteria

Feb 10, 2022

First Posted Date

Feb 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2025

Last Update Posted Date

Apr 2, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Giant cell arteritis - Optimization of diagnostics

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Giant cell arteritis	Diagnostic Test	Ultrasound 18F-fluorodeoxyglucose (18F-FDG) Positron Emission Tomography Temporal artery biopsy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Clinical suspicion of giant cell arteritis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steffen Hamann, MD, PhD,FEBO	Rigshospitalet, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet		Copenhagen			Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41793320	Derived	Hansen MS, Terslev L, Dohn UM, Fana V, Brittain JM, Wiencke AK, Heegaard S, Jensen MR, Klefter ON, Subhi Y, Hamann S. Ultrasound, PET/CT or temporal artery biopsy for giant cell arteritis? A prospective diagnostic accuracy study (the GAME-study). Acta Ophthalmol. 2026 Mar 7. doi: 10.1111/aos.70114. Online ahead of print.
39645178

ID	Term
D020293	Vasculitis, Central Nervous System
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D002561	Cerebrovascular Disorders