CXCR4-PET/CT for Diagnosing Giant Cell Arteritis

NCT05604482 | Completed

• 1 other identifier: CXCR4_PET_CT_RZA_V2.1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vasculitis; Diagnoses Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maximum measurable tracer activity on 68Ga-Pentixafor PET/CT in the area of blood vessels in active GCA

  detection of maximum measurable tracer activity on 68Ga-Pentixafor PET/CT in the area of blood vessels after a maximum of 5 days after diagnosis or when acute inflammatory activity of GCA is detected in terms of recurrence.

  2 years

Secondary Outcomes (3)

• Correlation with clinical parameters

  2 years

• Correlation with blood leukocyte count

  2 years

• Comparison to other imaging modalities

  2 years

Study Arms (1)

CXCR4-PET experimental group

EXPERIMENTAL

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

Diagnostic Test: CXCR4-PET

Interventions

CXCR4-PET DIAGNOSTIC_TEST

New imaging modality using CXCR4 for imaging in GCA

CXCR4-PET experimental group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Contraindications for the performance of a PET CT examination
• Pregnancy
• Allergies
• Lack of capacity of the patient to give informed consent

Sponsors & Collaborators

• Matthias Fröhlich: lead

Study Sites (1)

Departement of Internal Medicine II, Rheumatology/Clinical Immunology

Würzburg, Bavaria, 97074, Germany

Location

MeSH Terms

Conditions

Vasculitis; Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Arteritis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rudolf A Werner, MD

  University Hospital Würzburg Oberdürrbacherstrasse 6, 97080 Würzburg, Germany,

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med. Matthias Fröhlich

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 3, 2022
• Study Start: October 1, 2021
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)