NCT02771483

Brief Summary

Giant cell arteritis (GCA) is a medium to large vessel vasculitis with a predilection for the superficial cranial and intrathoracic arteries. Diagnosing the condition and predicting which patients will develop large vessel complications remains a challenge. There are limitations with temporal artery biopsy, magnetic resonance angiography and ultrasound of temporal arteries and American College of Rheumatology classification criteria. Positron emission tomography (PET) has been shown to be a useful modality in detecting inflammation in large intra-thoracic vessels but previously has not been able to accurately detect FDG uptake in the superficial cranial arteries due to poor spatial resolution. Newer scanners can perform finer cuts of the head and can detect uptake in these arteries. This study has three main components:

  1. 1.Cross sectional study assessing the accuracy of PET uptake in the superficial cranial and intrathoracic arteries of suspected GCA patients for the diagnosis of GCA
  2. 2.Cohort study assessing the prognostic implication of FDG aortic uptake on aortic diameter at 24 months
  3. 3.Cohort study assessing the Th1 and Th17 cytokine profile in patients with and without FDG PET uptake at 0, 6 and 24 months

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

May 15, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2020

Completed
Last Updated

March 12, 2020

Status Verified

March 1, 2020

Enrollment Period

3.7 years

First QC Date

May 9, 2016

Last Update Submit

March 10, 2020

Conditions

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of FDG uptake in the superficial cranial or intrathoracic arteries for the diagnosis of temporal artery biopsy proven GCA amongst patients with suspected GCA

    Baseline

Secondary Outcomes (7)

  • Difference in aortic diameter at 24 months between patients with and without PET scan aortic uptake at time 0.

    24 months

  • Difference in Th1 and Th17 axis cytokines in patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months

    24 months

  • Prevalence of varicella zoster virus antigen and DNA in temporal artery biopsy GCA specimens

    24 months

  • Prevalence of acute varicella zoster IgM serology positivity in biopsy confirmed GCA patients

    24 months

  • Difference in combined vascular events between GCA patients with and without thoracic large vessel PET uptake at 0, 6 and 24 months

    24 months

  • +2 more secondary outcomes

Study Arms (2)

Suspected GCA (GCA final diagnosis)

Suspected GCA (alternative final diagnosis)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Suspected GCA

You may qualify if:

  • Rheumatologist, neurologist or ophthalmologist suspect diagnosis of GCA
  • Age \> 50
  • Meet at least 2 of 1990 American College of Rheumatology classification criteria for GCA
  • Age \>= 50
  • ESR \>= 50
  • New onset localised headache
  • Temporal artery abnormality (tenderness or decreased pulsation)
  • Positive biopsy (will not be available at time of enrolment)

You may not qualify if:

  • Corticosteroid therapy for \> 72 hours before first PET scan
  • Prolonged corticosteroid therapy (\> 1 week) for another indication in past 6 months
  • History of vasculitis or connective tissue disease
  • Active malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Related Publications (1)

  • Sammel AM, Hsiao E, Schembri G, Nguyen K, Brewer J, Schrieber L, Janssen B, Youssef P, Fraser CL, Bailey E, Bailey DL, Roach P, Laurent R. Diagnostic Accuracy of Positron Emission Tomography/Computed Tomography of the Head, Neck, and Chest for Giant Cell Arteritis: A Prospective, Double-Blind, Cross-Sectional Study. Arthritis Rheumatol. 2019 Aug;71(8):1319-1328. doi: 10.1002/art.40864. Epub 2019 Jun 12.

    PMID: 30848549DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Temporal artery specimens Serology

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 DiseasesImmune System Diseases

Study Officials

  • Anthony M Sammel, MBBS

    Royal North Shore Hospital, St Leonards, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rheumatology fellow

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 13, 2016

Study Start

May 15, 2016

Primary Completion

January 28, 2020

Study Completion

January 28, 2020

Last Updated

March 12, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)