Back to results

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

Primary Purpose

Giant Cell Arteritis

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

68-Ga HA-DOTATATE PET/CT

About this trial

This is an interventional diagnostic trial for Giant Cell Arteritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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. :
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
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.

Sites / Locations

University of Alberta

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DOTATATE

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Correlation between vascular DOTATATE uptake scores and clinical status

Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure

Full Information

NCT ID

NCT03812302

First Posted

January 18, 2019

Last Updated

October 16, 2023

Sponsor

University of Alberta

1. Study Identification

Unique Protocol Identification Number

NCT03812302

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

September 9, 2019 (Actual)

Primary Completion Date

September 30, 2023 (Actual)

Study Completion Date

September 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Giant Cell Arteritis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DOTATATE

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

68-Ga HA-DOTATATE PET/CT

Intervention Description

See arm description.

Primary Outcome Measure Information:

Title

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

Time Frame

time 0 (baseline)

Secondary Outcome Measure Information:

Title

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

Time Frame

time 0 (baseline)

Title

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

Time Frame

6 months

Title

Correlation between vascular DOTATATE uptake scores and clinical status

Time Frame

0 and 6 months

Title

Correlation between vascular DOTATATE uptake scores and cumulative glucocorticoid exposure

Time Frame

0 and 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alison Clifford

Organizational Affiliation

University of Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alberta

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2G3

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23653652

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs