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

Last updated: August 25, 2025
Sponsor: Jewish General Hospital
Overall Status: Completed

Phase

N/A

Condition

Vascular Diseases

Circulation Disorders

Collagen Vascular Diseases

Treatment

FDG PET/CT

Clinical Study ID

NCT05000138
MP-05-2021-2846
  • Ages > 50
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 50 years, capable and willing to provide informed consent and can toleratePET/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 followingcriteria:

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

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 FDGbiodistribution.

Study Design

Total Participants: 92
Treatment Group(s): 1
Primary Treatment: FDG PET/CT
Phase:
Study Start date:
June 10, 2022
Estimated Completion Date:
August 25, 2025

Connect with a study center

  • Jewish General Hospital

    Montréal, Quebec H4R3E8
    Canada

    Site Not Available

  • Hôpital du Sacré-Cœur de Montréal

    Montreal 6077243, Quebec 6115047 H4J 1C5
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal 6077243, Quebec 6115047 H4R3E8
    Canada

    Site Not Available

  • CHUS

    Sherbrooke 6146143, Quebec 6115047 H3T1C5
    Canada

    Site Not Available

  • Université Bourgogne Europe, Centre Georges-François Leclerc

    Dijon 3021372, 21000
    France

    Site Not Available

  • University Medical Center Groningen

    Groningen 2755251,
    Netherlands

    Site Not Available

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