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CXCR4-PET/CT for Diagnosing Giant Cell Arteritis

Primary Purpose

Vasculitis, Diagnoses Disease

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
CXCR4-PET
Sponsored by
Matthias Fröhlich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vasculitis focused on measuring Vasculitis, LV-GCA, Giant cell arteritis, FDG-PET, Imaging, CXCR4

Eligibility Criteria

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

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

Sites / Locations

  • Departement of Internal Medicine II, Rheumatology/Clinical ImmunologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CXCR4-PET experimental group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Correlation with blood leukocyte count
Correlation of tracer uptake on imaging with CXCR4-positive peripheral blood leukocyte count.
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.

Full Information

First Posted
October 30, 2022
Last Updated
December 4, 2022
Sponsor
Matthias Fröhlich
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1. Study Identification

Unique Protocol Identification Number
NCT05604482
Brief Title
CXCR4-PET/CT for Diagnosing Giant Cell Arteritis
Official Title
Detection of Disease Activity in Giant Cell Arteritis Using CXCR4-PET/CT
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthias Fröhlich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasculitis, Diagnoses Disease
Keywords
Vasculitis, LV-GCA, Giant cell arteritis, FDG-PET, Imaging, CXCR4

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CXCR4-PET experimental group
Arm Type
Experimental
Arm Description
In addition to the current standard of imaging in GCA, using FDG-PET/CT, participants receive CXCR4-PET.
Intervention Type
Diagnostic Test
Intervention Name(s)
CXCR4-PET
Intervention Description
New imaging modality using CXCR4 for imaging in GCA
Primary Outcome Measure Information:
Title
Maximum measurable tracer activity on 68Ga-Pentixafor PET/CT in the area of blood vessels in active GCA
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Correlation with clinical parameters
Description
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.
Time Frame
2 years
Title
Correlation with blood leukocyte count
Description
Correlation of tracer uptake on imaging with CXCR4-positive peripheral blood leukocyte count.
Time Frame
2 years
Title
Comparison to other imaging modalities
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Fröhlich, MD
Phone
0049-931-201-44980
Email
froehlich_m@ukw.de
First Name & Middle Initial & Last Name or Official Title & Degree
Rudolf A. Werner, MD
Phone
0049-931-201-35000
Email
werner_r1@ukw.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf A Werner, MD
Organizational Affiliation
University Hospital Würzburg Oberdürrbacherstrasse 6, 97080 Würzburg, Germany,
Official's Role
Study Chair
Facility Information:
Facility Name
Departement of Internal Medicine II, Rheumatology/Clinical Immunology
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthias Fröhlich, MD
Phone
0049-931-201-44980
Email
froehlich_m@ukw.de
First Name & Middle Initial & Last Name & Degree
Marc Schmalzing, MD
Phone
0049-931-201-40905
Email
schmalzing_m@ukw.de

12. IPD Sharing Statement

Plan to Share IPD
No

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CXCR4-PET/CT for Diagnosing Giant Cell Arteritis

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