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

Giant Cell Arteritis Clinical Trial

Official title:

Evaluating the Use of Gallium-68 HA-DOTATATE Positron Emission Tomography/Computerized Tomography (PET/CT) in Patients With Giant Cell Arteritis (GCA.)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812302
• Other study ID #: Pro00085448
• Status: Completed
• Phase: Phase 2
• Start date: September 9, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Diagnostic Test:
• 68-Ga HA-DOTATATE PET/CT
See arm description.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of FDG vs DOTATATE vascular uptake in individual vascular territories using target-blood pool ratios (TBR)		time 0 (baseline)
Secondary	Qualitative comparison of FDG vs DOTATATE vascular uptake in individual vascular (scores 0-3) territories using visual uptake scores		time 0 (baseline)
Secondary	Changes in vascular DOTATATE uptake scores over time (quantitatively and qualitatively)		6 months
Secondary	Correlation between vascular DOTATATE uptake scores and clinical status		0 and 6 months
Secondary	Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure		0 and 6 months