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CompletedNCT05000138Updated Sep 2, 2025

FDG Digital PET/CT as First Line Investigation for Giant Cell Arteritis

An observational study in Giant Cell Arteritis and Vasculitis, sponsored by Jewish General Hospital. Completed at 5 sites in 3 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Jewish General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
92
Ages
50 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Giant Cell Arteritis
  • Vasculitis

Keywords

  • FDG PET/CT
  • digital PET
03

In context

Giant Cell Arteritis

170 studies on the registry are indexed under Giant Cell Arteritis; 48 are open to participants now.

This study's enrollment of 92 is below the median of 122 across 85 observational studies indexed under Giant Cell Arteritis.

Browse Giant Cell Arteritis studies →

Lead sponsor

Jewish General Hospital is the lead sponsor of 95 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with suspected GCA

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
92 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testFDG PET/CT

    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.

06

What researchers measure

Primary outcomes

  1. Diagnostic Performance

    of Digital PET/CT and DUS for the diagnosis of GCA

    Time frame: 2 years

07

Study locations

5 sites
  • Hôpital du Sacré-Cœur de Montréal
    Montreal, Quebec H4J 1C5, Canada
  • Jewish General Hospital
    Montreal, Quebec H4R3E8, Canada
  • CHUS
    Sherbrooke, Quebec H3T1C5, Canada
  • Université Bourgogne Europe, Centre Georges-François Leclerc
    Dijon, 21000, France
  • University Medical Center Groningen
    Groningen, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05000138
Lead sponsor
Jewish General Hospital
Responsible party
Gad Abikhzer (Associate Professor, Jewish General Hospital) — Principal investigator
First posted
Aug 11, 2021
Start date
Jun 10, 2022
Primary completion
Aug 25, 2025
Completion
Aug 25, 2025
Last update
Sep 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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