CXCR4-PET/CT for Diagnosing Giant Cell Arteritis

Diagnoses Disease Clinical Trial

Official title:

Detection of Disease Activity in Giant Cell Arteritis Using CXCR4-PET/CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05604482
• Other study ID #: CXCR4_PET_CT_RZA_V2.1
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2023
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Diagnoses Disease
• Giant Cell Arteritis
• Polymyalgia Rheumatica
• Vasculitis

Intervention

Diagnostic Test:
• CXCR4-PET
New imaging modality using CXCR4 for imaging in GCA

Locations

Country	Name	City	State
Germany	Departement of Internal Medicine II, Rheumatology/Clinical Immunology	Würzburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Matthias Fröhlich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation with clinical parameters	Correlation of the measured tracer activity with clinically and laboratory-chemically available parameters that are collected in clinical routine. These include CRP, peripheral blood leukocyte count, calprotectin, serum amyloid A, haptoglobin and Lactate dehydrogenase and their respective progression.	2 years
Secondary	Correlation with blood leukocyte count	Correlation of tracer uptake on imaging with CXCR4-positive peripheral blood leukocyte count.	2 years
Secondary	Comparison to other imaging modalities	Comparison with imaging findings from vasculitis MRI imaging implemented in standard clinical practice, duplex sonography (CCDS), and, if performed as part of routine clinical practice, FDG PET/CT data.	2 years