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

January 18, 2018 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Conventional FDG PET/CT including head in order to asses cranial arteries.
Other Names:
  • Inflammatory biomarkers
  • Temporal artery biopsy
  • Vascular ultrasound
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
Conventional FDG PET/CT including head in order to asses cranial arteries.
Other Names:
  • Inflammatory biomarkers
  • Temporal artery biopsy
  • Vascular ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET positivity
Time Frame: Time of diagnosis/pre-treatment (cases)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Full-fillment of ACR criteria
Time Frame: Time of diagnosis
PET sensitivity and specificity in the subpopulation of GCA patients full filling ACR criteria
Time of diagnosis
Temporal artery biopsy
Time Frame: Time of diagnosis
Correlation between temporal artery biopsy result and temporal artery FDG uptake
Time of diagnosis
Temporal artery ultrasound
Time Frame: Time of diagnosis
Correlation between temporal artery ultrasound result and temporal artery FDG uptake
Time of diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Chair: Lars Christian Gormsen, MD, PhD, Department of Nuclear Medicine and PET centre, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 24, 2018

Study Record Updates

Last Update Posted (Actual)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cranial_GCA_PET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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