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

NCT03812302 | Completed Phase 2

• 1 other identifier: Pro00085448
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Giant Cell Arteritis

Outcome Measures

Primary Outcomes (1)

• Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR)

  time 0 (baseline)

Secondary Outcomes (4)

• Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores

  time 0 (baseline)

• Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively)

  6 months

• Correlation between vascular DOTATATE uptake scores and clinical status

  0 and 6 months

• Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure

  0 and 6 months

Study Arms (1)

DOTATATE

EXPERIMENTAL

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

Interventions

68-Ga HA-DOTATATE PET/CT DIAGNOSTIC_TEST

See arm description.

DOTATATE

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients not meeting the above criteria or who are unable to provide informed consent will be excluded.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

Location

Related Publications (2)

• Unizony SH, Dasgupta B, Fisheleva E, Rowell L, Schett G, Spiera R, Zwerina J, Harari O, Stone JH. Design of the tocilizumab in giant cell arteritis trial. Int J Rheumatol. 2013;2013:912562. doi: 10.1155/2013/912562. Epub 2013 Apr 7.

  PMID: 23653652 RESULT

• Clifford AH, Abele J, Hung R, Wuest F, Andersson J, Pike S, Yacyshyn E, Lenza E, Jickling G, Raggi P, Cohen Tervaert JW. Comparison of [18F]fluorodeoxyglucose and [68Ga]Gallium DOTA-TATE in patients with active giant cell arteritis. EJNMMI Rep. 2025 Mar 1;9(1):7. doi: 10.1186/s41824-025-00242-y.

  PMID: 40021570 DERIVED

MeSH Terms

Conditions

Giant Cell Arteritis

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; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alison Clifford

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 23, 2019
• Study Start: September 9, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)