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CXCR4-PET/CT for Diagnosing Giant Cell Arteritis

NCT ID: NCT05604482

Last Updated: 2023-12-15

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-09-30

Brief Summary

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Giant cell arteritis (GCA) is the most common vasculitis in the elderly. Accurate diagnosis is of utmost importance in order to then initiate the necessary immunosuppressive therapy. For large-vessel GCA (LV-GCA) involving the aorta and its branches, FDG-PET/CT is the standard in imaging for diagnosis and is recommended by the guidelines. However, this only indirectly visualizes inflammation through vessel wall uptake of glucose. A new PET tracer, 68Ga-pentixafor, is used to visualize the chemokine receptor CXCR4. This receptor is expressed by cells of the immune system. In the context of inflammatory processes, upregulation of CXCL12, the ligand of CXCR4, occurs in affected tissues. The chemotactic effect of this ligand leads to the immigration of CXCR4-positive inflammatory cells into the inflamed area, which can be visualized by PET using the CXCR4-specific tracer 68Ga-Pentixafor. The value of CXCR4-PET should therefore be tested in the context of LV-GCA. This study tests the benefit of CXCR4 in therapy-naïve patients with suspected LV-GCA. For this purpose, patients will receive a FDG-PET and a CXCR4-PET for direct comparison. This is an imaging-only study. Therapy will not be affected by the study. The study is single-arm and not blinded.

Detailed Description

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Conditions

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Vasculitis Diagnoses Disease

Keywords

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Vasculitis LV-GCA Giant cell arteritis FDG-PET Imaging CXCR4

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CXCR4-PET experimental group

In addition to the current standard of imaging in GCA, using FDG-PET/CT, participants receive CXCR4-PET.

Group Type EXPERIMENTAL

CXCR4-PET

Intervention Type DIAGNOSTIC_TEST

New imaging modality using CXCR4 for imaging in GCA

Interventions

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CXCR4-PET

New imaging modality using CXCR4 for imaging in GCA

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* New diagnosis of GCA within 5 days of diagnosis or initiation or intensification of therapy.
* Evidence of inflammatory activity based on clinical parameters, elevated serologic markers of inflammation (CRP \> 1.0 mg/dl), or a positive imaging finding on vasculitis MRI, CCDS, or FDG-PET/CT
* Ability of the patient to provide information
* Exclusion of contraindications for the performance of a PET/CT examination (see below)

Exclusion Criteria

* Contraindications for the performance of a PET CT examination
* Pregnancy
* Allergies
* Lack of capacity of the patient to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Matthias Fröhlich

OTHER

Sponsor Role lead

Responsible Party

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Matthias Fröhlich

Dr. med. Matthias Fröhlich

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rudolf A Werner, MD

Role: STUDY_CHAIR

University Hospital Würzburg Oberdürrbacherstrasse 6, 97080 Würzburg, Germany,

Locations

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Departement of Internal Medicine II, Rheumatology/Clinical Immunology

Würzburg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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CXCR4_PET_CT_RZA_V2.1

Identifier Type: -

Identifier Source: org_study_id