Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis

NCT03765424 | Completed

• 1 other identifier: ULvsPET GCA cohort
• Study Type: observational
• Target: 101
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this project is to prospectively evaluate the diagnostic accuracy of different imaging tools in specific giant cell arteritis disease subsets before and after treatment initiation. Diagnostic tools with high sensitivity and specificity are a prerequisite for optimal treatment of GCA patients. Specifically, the diagnostic accuracy of ultrasound (US) as compared to 18F-FDG PET/CT in new-onset, treatment naïve large vessel(LV)-GCA patients is investigated. Furthermore, long-term follow up including US, 18F-FDG PET/CT and cross sectional imaging is performed to explore the potential of imaging as monitoring and prognostic tools. In this observational cohort, the diagnostic accuracy of 18F-FDG PET/CT after three and ten days of glucocorticoid treatment in the subset of LV-GCA patients and the diagnostic accuracy of 18F-FDG PET/CT in cranial artery inflammation in new-onset, treatment naïve c-GCA patients as compared to a control group of patients with a previous diagnosis of malignant melanoma was also evaluated and is registered elsewhere (ClinicalTrials.gov Identifier: NCT03285945 and NCT03409913, respectively)

Conditions

Giant Cell Arteritis; Vasculitis

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of large vessel ultrasound with PET/CT as reference

  Large vessel ultrasound for LV-GCA diagnosis is considered positive in the presence of a halo in carotid and/or axillary arteries.

  Time of diagnosis/pre-treatment

Secondary Outcomes (16)

• Large vessel intima-media thickness (IMT) cut off for LV-GCA diagnosis with PET/CT as reference

  Time of diagnosis/pre-treatment

• Diagnostic accuracy vascular ultrasound (overall)

  Time of diagnosis/pre-treatment

• Diagnostic accuracy of vascular ultrasound after treatment (day 3, 10 and week 8)

  3 days, 10 days and 8 weeks after initiated treatment

• Diagnostic accuracy of PET/CT of cranial arteries for c-GCA diagnosis (reference: American College of Rheumatology 1990 criteria)

  Time of diagnosis/pre-treatment

• Temporal artery biopsy

  Time of diagnosis

Other Outcomes (7)

• Patient global NRS

  Baseline, day 10, week 8, 24 and 15 months

• Physician NRS

  Baseline, day 10, week 8, 24 and 15 months

• CRP

  Baseline, day 3 and 10, week 8, 24 and 15 months

Study Arms (2)

GCA cases

GCA cases were patients with a clinical diagnosis of GCA based on a rheumatologists evaluation of history taking, physical examination, laboratory screening and initial PET report (reporting potential large vessel inflammation but not considering cranial artery inflammation). GCA was considered large vessel (LV) and/or cranial (c) GCA cases: LV-GCA cases were patients with a clinical diagnosis of GCA and verified LV inflammation by 18F-FDG PET/CT with or without concomitant c-GCA. C-GCA cases, for the exploratory analysis of the performance of US and PET in c-GCA, were patients with a clinical diagnosis of GCA fulfilling the 1990 American College of Rheumatology (ACR) criteria, with or without concomitant LV-GCA.

Diagnostic Test: Ultrasound

controls

Controls were GCA suspected patients in whom GCA diagnosis was dismissed.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

Ultraosund of temporal, carotid and axillary arteries

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

For the GCA suspect cohort, patients referred to Department of Rheumatology, Aarhus University Hospital due to suspicion of GCA are considered for inclusion. Patients in whom a 18F-FDG PET/CT is not performed by the time of referral and who presents with unequivocal cranial symptoms of GCA requiring acute initiation of GC treatment are not considered for inclusion.

You may qualify if:

• Age more than 50 years
• C-reactive protein (CRP)\>15 mg/L or erythrocyte sedimentation rate (ESR)\>40 mm/h
• Either
• cranial symptoms such as new-onset headache or scalp tenderness, jaw or tongue claudication, visual disturbances
• new-onset limb claudication
• protracted constitutional symptoms, defined as weight loss\>5 kilograms or fever\>38 degrees Celcius for \>3 weeks
• Bilateral shoulder pain and morning stiffness.

You may not qualify if:

• oral glucocorticoid treatment within the past month;
• subcutaneous, intramuscular, intra-articular or intravenous glucocorticoid within the past 2 months;
• DMARD treatment or other immunosuppressive therapy within the past 3 months;
• ongoing treatment with interleukin2;
• previous diagnosis of GCA or polymyalgia rheumatica;
• any disease potentially causing large vessel inflammation, that is autoimmune diseases; rheumatoid arthritis, Cogans syndrome, relapsing polychondritis, ankylosing spondylitis, systemic lupus erythematosus, Buerger's disease, Bechet's disease, inflammatory bowel disease, infections; syphilis, known active current or history of recurrent tuberculosis, hepatitis or HIV, or other large vessel disease; sarcoidosis, neurofibromatosis, congenital coarctation, Marfans syndrome, Ehlers-Danlos syndrome, retroperitoneal fibrosis.

Sponsors & Collaborators

• University of Aarhus: lead
• The Danish Rheumatism Association: collaborator
• Hartmann Fonden: collaborator
• AP Moeller Foundation: collaborator
• Aase and Ejnar Danielsens Foundation: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Full blood EDTA plasma Lithium-heparin plasma serum

MeSH Terms

Conditions

Giant Cell Arteritis; Vasculitis

Interventions

Ultrasonography

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Berit Nielsen, MD

  Department of Rheumatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 5, 2018
• Study Start: October 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: December 31, 2018
• Last Updated: October 4, 2021

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share