Giant Cell ArteritisNCT05000138
FDG Digital PET/CT as First Line Investigation for Giant Cell Arteritis
An observational study of Giant Cell Arteritis and Vasculitis, run by Jewish General Hospital at 5 sites in 3 countries.
Trial summary
Giant cell arteritis (GCA) causes inflammation of the arteries and can lead to serious complications such as blindness, necessitating rapid diagnosis and treatment. Although older technology non-digital PET/CT scans are routinely used for the diagnosis of GCA in large arteries, they have not been able to reliably… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis, Vasculitis
- What is being tested?
- FDG PET/CT
- How many people
- 92 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 10 Jun 2022to 25 Aug 2025
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspected GCA
Who may be able to join
- Age ≥ 50 years, capable and willing to provide informed consent and can tolerate PET/CT.
- ESR ≥ 50 mm/h and/or CRP ≥ 10mg/L within 1 week of PET/CT referral.
- New suspected giant cell arteritis according to at least one of the following criteria:
- Cranial GCA symptoms (new-onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, masseter pain on prolonged mastication) PMR symptoms: shoulder and/or hip girdle pain associated with inflammatory stiffness.
- Suspected large-vessel vasculitis based on angiography, MRA, or CTA.
Who cannot join
- Initiation of corticosteroid or immunosuppressive therapy >4 days before PET/CT.
- Prior TAB or treated GCA with suspected relapse.
- Non-fasting or hyperglycemia (>11.1 mmol/L) resulting in altered FDG biodistribution.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Canada3 sites
Hôpital du Sacré-Cœur de Montréal
Montreal, Quebec, H4J 1C5
Jewish General Hospital
Montreal, Quebec, H4R3E8
CHUS
Sherbrooke, Quebec, H3T1C5
France1 site
Université Bourgogne Europe, Centre Georges-François Leclerc
Dijon, 21000
About this study
Giant cell arteritis (GCA) causes inflammation of the arteries and can lead to serious complications such as blindness, necessitating rapid diagnosis and treatment. Although older technology non-digital PET/CT scans are routinely used for the diagnosis of GCA in large arteries, they have not been able to reliably detect inflammation of the small arteries responsible for blindness. Recent technological advances have enabled PET/CT imaging of millimetric disease in the body, which are now able to resolve small arteries. In the proposed research study, patients who are suspected by their doctors to have GCA will undergo an ultrasound of the temporal arteries, and digital PET/CT scan after injection of radioactive glucose. Digital PET/CT scans will be interpreted for the presence of abnormal uptake in the large and small arteries, as well as for the presence of other causes of the patient's symptoms. The diagnostic accuracy of PET/CT and ultrasound will be evaluated with respect to an expert panel diagnosis of giant cell arteritis and compared. Results will be adjusted for lack of a perfect reference test using advanced statistics. The goal will be to see if digital PET/CT can become a single, integrated test to diagnose this disease.
- Conditions
- Giant Cell Arteritis, Vasculitis
- Being tested
- FDG PET/CT
- Keywords
- FDG PET/CT, digital PET
- Medical subject headings
- Giant Cell Arteritis, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PET/CTDiagnostic test
Patients with suspected giant cell arteritis, of which FDG PET/CT is indicated for diagnosis of large vessel involvement, will have the small cranial arteries analyzed for involvement.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance
of Digital PET/CT and DUS for the diagnosis of GCA
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start10 Jun 2022
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gad Abikhzer, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000138
- Sponsor's protocol ID
- MP-05-2021-2846
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abikhzer G, Roy A, Samson M, Dendukuri N, Makhzoum JP, Stein MA, Hudson M, Rousseau E, Nienhuis PH, Van der Geest KSM, Pineau C, Liang P, Levin LA, Slart RHJA, Alberini JL. Digital [18F]FDG PET/CT as first-line diagnostic modality for cranial giant cell arteritis. Eur J Nucl Med Mol Imaging. 2026 Aug 21. doi: 10.1007/s00259-026-08131-7. Online ahead of print.
PubMed 42625054
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG Digital PET/CT as First Line Investigation for Giant Cell Arteritis
- ClinicalTrials.gov ID
- NCT05000138
- Acronym / sponsor ID
- MP-05-2021-2846
- Conditions
- Giant Cell Arteritis, Vasculitis
- Keywords
- FDG PET/CT, digital PET
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 11 Aug 2021 (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 (GCA) causes inflammation of the arteries and can lead to serious complications such as blindness, necessitating rapid diagnosis and treatment. Although older technology non-digital PET/CT scans are routinely used for the diagnosis of GCA in large arteries, they have not been able to reliably detect inflammation of the small arteries responsible for blindness. Recent technological advances have enabled PET/CT imaging of millimetric disease in the body, which are now able to resolve small arteries. In the proposed research study, patients who are suspected by their doctors to have GCA will undergo an ultrasound of the temporal arteries, and digital PET/CT scan after injection of radioactive glucose. Digital PET/CT scans will be interpreted for the presence of abnormal uptake in the large and small arteries, as well as for the presence of other causes of the patient's symptoms. The diagnostic accuracy of PET/CT and ultrasound will be evaluated with respect to an expert panel diagnosis of giant cell arteritis and compared. Results will be adjusted for lack of a perfect reference test using advanced statistics. The goal will be to see if digital PET/CT can become a single, integrated test to diagnose this disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected GCA
Key inclusion criteria (5 listed)
- Age ≥ 50 years, capable and willing to provide informed consent and can tolerate PET/CT.
- ESR ≥ 50 mm/h and/or CRP ≥ 10mg/L within 1 week of PET/CT referral.
- New suspected giant cell arteritis according to at least one of the following criteria:
- Cranial GCA symptoms (new-onset localized headache, scalp or temporal artery tenderness, ischemia-related vision loss, masseter pain on prolonged mastication) PMR symptoms: shoulder and/or hip girdle pain associated with inflammatory stiffness.
- Suspected large-vessel vasculitis based on angiography, MRA, or CTA.
Key exclusion criteria (3 listed)
- Initiation of corticosteroid or immunosuppressive therapy >4 days before PET/CT.
- Prior TAB or treated GCA with suspected relapse.
- Non-fasting or hyperglycemia (>11.1 mmol/L) resulting in altered FDG biodistribution.
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 |
|---|---|---|
| FDG PET/CTPatients with suspected giant cell arteritis, of which FDG PET/CT is indicated for diagnosis of large vessel involvement, will have the small cranial arteries analyzed for involvement. | Diagnostic test | – |
Primary outcome
Diagnostic Performance
Time frame: 2 years
of Digital PET/CT and DUS for the diagnosis of GCA
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 Sep 2025.
- Derived from this study: PubMed 42625054Abikhzer G, Roy A, Samson M, Dendukuri N, Makhzoum JP, Stein MA, Hudson M, Rousseau E, Nienhuis PH, Van der Geest KSM, Pineau C, Liang P, Levin LA, Slart RHJA, Alberini JL. Digital [18F]FDG PET/CT as first-line diagnostic modality for cranial giant cell arteritis. Eur J Nucl Med Mol Imaging. 2026 Aug 21. doi: 10.1007/s00259-026-08131-7. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis and Vasculitis, run by Jewish General Hospital at 5 sites in 3 countries.
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 5 inclusion and 3 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, France, Netherlands. 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?
Diagnostic Performance (time frame: 2 years). 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 NCT05000138, which also lists 1 linked publication.
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 Sep 2025.