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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 October 2023 |
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Main ID: |
NCT03812302 |
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Date of registration:
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18/01/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)
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Scientific title:
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Evaluating the Use of Gallium-68 HA-DOTATATE Positron Emission Tomography/Computerized Tomography (PET/CT) in Patients With Giant Cell Arteritis (GCA.) |
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Date of first enrolment:
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September 9, 2019 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03812302 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Alison Clifford |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Alberta |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Participants must:
1. Meet the revised GCA diagnosis criteria (modified from ref 1)
2. Have either newly-diagnosed or relapsing disease
3. Have active disease (modified from ref 1, to remove ESR/CRP requirements)
4. Have been empirically started on glucocorticoid treatment (or had baseline
glucocorticoid dose increased, in the case of relapsers) = 2 weeks of enrolment
5. 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).
1. Age = 50 years
2. And at least 1 of a. or b. :
1. Unequivocal cranial symptoms of GCA (new headache, scalp or temporal artery
tenderness, ischemia-related vision loss, jaw/mouth claudication
2. Unequivocal symptoms of polymyalgia rheumatica (PMR), defined as shoulder and/or
hip girdle pain associated with inflammatory stiffness
3. And at least 1 of a. or b.:
1. Temporal artery biopsy revealing features of GCA
2. 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 Criteria:
- Patients not meeting the above criteria or who are unable to provide informed consent
will be excluded.
Age minimum:
50 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Giant Cell Arteritis
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Intervention(s)
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Diagnostic Test: 68-Ga HA-DOTATATE PET/CT
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Primary Outcome(s)
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Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR)
[Time Frame: time 0 (baseline)]
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Secondary Outcome(s)
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Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores
[Time Frame: time 0 (baseline)]
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Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively)
[Time Frame: 6 months]
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Correlation between vascular DOTATATE uptake scores and clinical status
[Time Frame: 0 and 6 months]
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Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure
[Time Frame: 0 and 6 months]
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Secondary ID(s)
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Pro00085448
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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