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

NCT03409913 | Completed

• 1 other identifier: Cranial_GCA_PET
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Giant Cell Arteritis

Keywords

positron emissions tomography; diagnostic accuracy; case-control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Full-fillment of ACR criteria

  Time of diagnosis

• Temporal artery biopsy

  Time of diagnosis

• Temporal artery ultrasound

  Time of diagnosis

Study Arms (2)

GCA cases

In a cohort of patients suspected of GCA based on the following inclusion criteria were 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, patients with a clinical diagnosis of GCA is identified.

Radiation: FDG PET/CT

controls

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

Radiation: FDG PET/CT

Interventions

FDG PET/CT RADIATION

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

Also known as: Temporal artery biopsy, Vascular ultrasound, Inflammatory biomarkers

GCA cases; controls

Eligibility Criteria

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

Study Population

All patients are sampled from tertiary hospital. Cases are identified in an established cohort of patients suspected og GCA in whom clinical assessment, including imaging procedures were performed before treatment. Controls are sampled among malignant melanoma patients who had a clinically indicated follow-up FDG PET/CT to evaluate disease freedom/progression.

You may qualify if:

• Cases:
• \) 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

You may not qualify if:

• Previous diagnosis of polymyalgia or giant cell arteritis
• immunosuppresive treatment within last month

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Rheumatology

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Giant Cell Arteritis

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; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Lars Christian Gormsen, MD, PhD

  Department of Nuclear Medicine and PET centre, Aarhus University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 24, 2018
• Study Start: October 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: January 24, 2018

Record last verified: 2018-01

Locations

DK (1)