Diagnostic Accuracy of FDG PET/CT of Cranial Arteries in GCA

Giant Cell Arteritis Clinical Trial

Official title:

Conventional FDG PET/CT Accurately Diagnoses Temporal Arteritis in Glucocorticoid-naïve GCA Patients: a Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409913
• Other study ID #: Cranial_GCA_PET
• Status: Completed
• Phase: N/A
• First received: January 18, 2018
• Last updated: January 18, 2018
• Start date: October 1, 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: January 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A case-control study to evaluate the diagnostic accuracy of FDG uptake in cranial arteries by FDG PET/CT in the diagnosis of giant cell arteritis.

Description:

Although older studies argue that FDG PET/CT cannot demonstrate inflammation in cranial arteries, e.g. temporal and maxillary arteries, the resolution of modern PET systems may have improved, making a case for FDG PET/CT. FDG PET/CT is increasingly used in giant cell arteritis (GCA) diagnosis due to its excellent diagnostic accuracy considering large-vessel involvement. In case of uncommon distribution of vessel involvement or marginally increased large-vessel FDG uptake, FDG PET/CT-specificity may be compromised. Hence, recognising FDG uptake in cranial arteries potentially adds to FDG PET/CTs diagnostic accuracy.

Objectives To evaluate the diagnostic accuracy of conventional FDG PET/CT of the cranial arteries in the diagnosis of GCA.

Methods In a cohort of consecutively included glucocorticoid-naïve patients suspected of new-onset GCA, patients with a clinical GCA diagnosis will be identified. Conventional FDG PET/CT and vascular ultrasound(US) was performed before treatment. Patients were referred for a temporal artery biopsy (TAB).

Controls are age-(+/- 3 years) and sex-matched malignant melanoma (MM) patients who had a follow-up metastatic-disease-free FDG PET/CT ≥6 months after MM resection.

Images will be assessed by 5 nuclear medicine physicians blinded to clinical symptoms and findings. Temporal (TA), maxillary (MA) and vertebral (VA) arteries will be visually assessed. Arterial FDG uptake more than FDG uptake in surrounding tissue is considered positive. Sensitivity, specificity and interreader agreement will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

Cases:

• 1) age =50 years, 2) CRP>15mg/l or ESR>40mm/h, 3) either a) cranial symptoms, b) new-onset extremity claudication or c) weight loss >5 kilograms or fever>38oC for >3 weeks and a clinical diagnosis of giant cell arteritis judged by expert rheumatologist.

Controls:

• age-(+/-3 years) and sex-matched malignant melanoma (MM) patients

• follow-up metastatic-disease-free FDG PET/CT =6 months after MM resection

Exclusion Criteria:

• Previous diagnosis of polymyalgia or giant cell arteritis

• immunosuppresive treatment within last month

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Radiation:
• FDG PET/CT
Conventional FDG PET/CT including head in order to asses cranial arteries.

Locations

Country	Name	City	State
Denmark	Department of Rheumatology	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET positivity	Presence of FDG uptake in temporal, maxillary and/or vertebral arteries assessed in order to evaluate sensitivity and specificity of PET of cranial arteries in the diagnosis of GCA	Time of diagnosis/pre-treatment (cases)
Secondary	Full-fillment of ACR criteria	PET sensitivity and specificity in the subpopulation of GCA patients full filling ACR criteria	Time of diagnosis
Secondary	Temporal artery biopsy	Correlation between temporal artery biopsy result and temporal artery FDG uptake	Time of diagnosis
Secondary	Temporal artery ultrasound	Correlation between temporal artery ultrasound result and temporal artery FDG uptake	Time of diagnosis