Trials Sponsors Conditions Drugs Pricing

Conditions

Giant Cell Arteritis

Keywords

positron emissions tomographydiagnostic accuracycase-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/CTRadiation

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

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

GCA casescontrols

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability 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:

Sponsors & Collaborators

University of Aarhus
Otherlead

Study Sites (1)

Department of Rheumatology

Aarhus, 8000, Denmark

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune Diseases

Study Officials

Lars Christian Gormsen, MD, PhD
Department of Nuclear Medicine and PET centre, Aarhus University Hospital
STUDY CHAIR

Enrollment

106 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

GCA cases

controls

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

GCA cases

controls

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations