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Use of Gallium-68 HA-DOTATATE PET/CT in Giant Cell Arteritis (GCA)

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ClinicalTrials.gov Identifier: NCT03812302
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Description
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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 DOTATATE can identify more areas of active blood vessel inflammation than FDG.

Condition or disease Intervention/treatment Phase
Giant Cell Arteritis Diagnostic Test: 68-Ga HA-DOTATATE PET/CT Phase 2

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, as compared to FDG PET/CT, and to understand if DOTATATE uptake correlates with disease activity. Fifteen patients with active GCA (either newly-diagnosed or recently relapsed disease) who are receiving glucocorticoids will be enrolled. Participants will undergo baseline FDG PET/CT and baseline DOTATATE PET/CT scan. Tracer uptake will be described in 8 major vascular territories. DOTATATE PET/CT will be repeated again in 6 months, and tracer uptake will be correlated to clinical disease activity, and medication use.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 68-Ga HA-DOTATATE PET/CT will be performed in all participants as part of study protocol. Participants will receive an intravenous infusion of 3MBq/kg of 68Ga HA-DOTATATE (to max 200 MBq), followed by CT and PET imaging 60 minutes later. Tracer uptake in each vascular territory will be interpreted qualitatively and quantitatively.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluating the Use of Gallium-68 HA-DOTATATE Positron Emission Tomography/Computerized Tomography (PET/CT) in Patients With Giant Cell Arteritis (GCA.)
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: DOTATATE
All 15 GCA patients will undergo 68-Ga HA-DOTATATE PET/CT imaging at baseline, in addition to FDG PET/CTA (as part of standard of care). DOTATATE PET/CT imaging will be repeated at 6 months follow-up.
 Diagnostic Test: 68-Ga HA-DOTATATE PET/CT
See arm description.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR) [ Time Frame: time 0 (baseline) ]

Secondary Outcome Measures :
  1. Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores [ Time Frame: time 0 (baseline) ]
  2. Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively) [ Time Frame: 6 months ]
  3. Correlation between vascular DOTATATE uptake scores and clinical status [ Time Frame: 0 and 6 months ]
  4. Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure [ Time Frame: 0 and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03812302


Contacts
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Contact: Alison Clifford 780-492-8789 alison5@ualberta.ca
Contact: Jan Willem Cohen Tervaert 780-492-7481 cohenter@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2G3
Contact: Alison Clifford    780-492-8789    alison5@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Alison Clifford University of Alberta
More Information
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Publications of Results:

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03812302    
Other Study ID Numbers: Pro00085448
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Arteritis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases