Giant Cell ArteritisGAMENCT05248906
Giant Cell Arteritis - Optimization of Diagnostics
An observational study of Giant Cell Arteritis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Giant cell arteritis - Optimization of diagnostics Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- Giant cell arteritis
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Mar 2021to 1 Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinical suspicion of giant cell arteritis
Who may be able to join
- 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
Who cannot join
- Active cancer Use of steroid for more than a week (the prior 6 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Giant Cell Arteritis - Examination of the Optimal Diagnostic Pathway
Giant cell arteritis - Optimization of diagnostics
Read the 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.
- Conditions
- Giant Cell Arteritis
- Being tested
- Giant cell arteritis
- Keywords
- Temporal artery biopsy,, Giant cell arteritis, Ultrasound, 18F-FDG PET/CT
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giant cell arteritisDiagnostic test
Ultrasound 18F-fluorodeoxyglucose (18F-FDG) Positron Emission Tomography Temporal artery biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Giant cell arteritis
Clinical verification of giant cell arteritis diagnosis as evaluated with a combination of ultrasound, biopsy and PET/CT.
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start19 Mar 2021
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steffen Hamann, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Steffen Hamann, MD, PhD,FEBO, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248906
- Sponsor's protocol ID
- H-20032069
- Acronym
- GAME
- Status last verified
- Feb 2022
- First submitted
- 3 Nov 2020
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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 Sep;104(6):e695-e708. doi: 10.1111/aos.70114. Epub 2026 Mar 7.
PubMed 41793320Klefter ON, Hansen MS, Lykkebirk L, Subhi Y, Brittain JM, Jensen MR, Dohn UM, Fana V, Wiencke AK, Heegaard S, Terslev L, Hamann S. Combining Paracentral Acute Middle Maculopathy and Peripapillary Fluid as Biomarkers in Anterior Ischemic Optic Neuropathy. Am J Ophthalmol. 2025 Mar;271:329-336. doi: 10.1016/j.ajo.2024.12.001. Epub 2024 Dec 6.
PubMed 39645178
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Giant Cell Arteritis - Examination of the Optimal Diagnostic Pathway
- ClinicalTrials.gov ID
- NCT05248906
- Acronym / sponsor ID
- GAME / H-20032069
- Conditions
- Giant Cell Arteritis
- Keywords
- Temporal artery biopsy,, Giant cell arteritis, Ultrasound, 18F-FDG PET/CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 21 Feb 2022 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical suspicion of giant cell arteritis
Key inclusion criteria (3 listed)
- Clinical suspicion of giant cell arteritis
- Age at disease onset => 50 years New headache Temporal artery abnormality Elevated erythrocyte sedimentation rate >=50 mm/hour Abnomal artery biopsy
Key exclusion criteria (1 listed)
- Active cancer Use of steroid for more than a week (the prior 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Giant cell arteritisUltrasound 18F-fluorodeoxyglucose (18F-FDG) Positron Emission Tomography Temporal artery biopsy | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 41793320Hansen 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 Sep;104(6):e695-e708. doi: 10.1111/aos.70114. Epub 2026 Mar 7.
- Derived from this study: PubMed 39645178Klefter ON, Hansen MS, Lykkebirk L, Subhi Y, Brittain JM, Jensen MR, Dohn UM, Fana V, Wiencke AK, Heegaard S, Terslev L, Hamann S. Combining Paracentral Acute Middle Maculopathy and Peripapillary Fluid as Biomarkers in Anterior Ischemic Optic Neuropathy. Am J Ophthalmol. 2025 Mar;271:329-336. doi: 10.1016/j.ajo.2024.12.001. Epub 2024 Dec 6.
- Individual participant dataSharing planned: Undecided
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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.
Steffen Hamann, MD, PhD,FEBO principal investigator
Copenhagen University Hospital, Rigshospitalet
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 Giant Cell Arteritis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 2 Apr 2025. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Giant cell arteritis (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05248906, which also lists 2 linked publications.
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 2 Apr 2025.