Status:
COMPLETED
Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)
Lead Sponsor:
University of Alberta
Conditions:
Giant Cell Arteritis
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to compare the use of FDG PET/CT to Ga-68 HA-DOTATATE (abbreviated DOTATATE) PET/CT in patients with active giant cell arteritis (GCA) started on prednisone to understand if D...
Detailed Description
The aim of this study is to prospectively evaluate the potential use of 68-Ga HA-DOTATATE PET/CT for detecting medium-large vessel inflammation in a small number of GCA patients with active disease, a...
Eligibility Criteria
Inclusion
- Participants must:
- Meet the revised GCA diagnosis criteria (modified from ref 1)
- Have either newly-diagnosed or relapsing disease
- Have active disease (modified from ref 1, to remove ESR/CRP requirements)
- Have been empirically started on glucocorticoid treatment (or had baseline glucocorticoid dose increased, in the case of relapsers) ≤ 2 weeks of enrolment
- Participant must be have had (or will be willing to undergo) an urgent FDG-PET/CT as part of routine clinical care.
- GCA diagnosis criteria (modified from ref 1, to remove ESR requirement).
- Age ≥ 50 years
- And at least 1 of a. or b. :
- Unequivocal cranial symptoms of GCA (new headache, scalp or temporal artery tenderness, ischemia-related vision loss, jaw/mouth claudication
- Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or hip girdle pain associated with inflammatory stiffness
- And at least 1 of a. or b.:
- Temporal artery biopsy revealing features of GCA
- Evidence of large-vessel vasculitis by angiography or cross-sectional imaging study such as magnetic resonance angiography (MRA), computed tomography angiography (CTA), or positron emission tomography-computed tomography (PET-CT)
Exclusion
- Patients not meeting the above criteria or who are unable to provide informed consent will be excluded.
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03812302
Start Date
September 9 2019
End Date
September 30 2023
Last Update
October 18 2023
Active Locations (1)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3