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

NCT05000138 | Completed

• 1 other identifier: MP-05-2021-2846
• Study Type: observational
• Target: 92
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Giant Cell Arteritis; Vasculitis

Keywords

FDG PET/CT; digital PET

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance

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

  2 years

Interventions

FDG PET/CT DIAGNOSTIC_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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with suspected GCA

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jewish General Hospital: lead

Study Sites (5)

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, H4J 1C5, Canada

Location

Jewish General Hospital

Montreal, Quebec, H4R3E8, Canada

Location

CHUS

Sherbrooke, Quebec, H3T1C5, Canada

Location

Université Bourgogne Europe, Centre Georges-François Leclerc

Dijon, 21000, France

Location

University Medical Center Groningen

Groningen, Netherlands

Location

MeSH Terms

Conditions

Giant Cell Arteritis; Vasculitis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: June 10, 2022
• Primary Completion: August 25, 2025
• Study Completion: August 25, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); CA (3); NL (1)