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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-09

Study Completion Date

2023-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Ultrasound and PET/CT in the Diagnosis and Monitoring of Giant Cell Arteritis

NCT03765424

Giant Cell Arteritis Vasculitis

COMPLETED

Vascular Inflammation Imaging Using Somatostatin Receptor Positron Emission Tomography

NCT02021188

Atherosclerosis Stroke Transient Ischemic Attack +2 more

COMPLETED

CXCR4-PET/CT for Diagnosing Giant Cell Arteritis

NCT05604482

Vasculitis Diagnoses Disease

COMPLETED NA

Validation of a Diagnostic Algorithm of Giant Cell Arteritis

NCT02703922

Giant Cell Arteritis

COMPLETED NA

Cardiac Involvement in Patients With Giant Cell Arteritis

NCT07031284

Giant Cell Arteritis (GCA)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Giant Cell Arteritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

68-Ga HA-DOTATATE PET/CT

Intervention Type DIAGNOSTIC_TEST

See arm description.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

68-Ga HA-DOTATATE PET/CT

See arm description.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)