VasculitisNCT05604482
CXCR4-PET/CT for Diagnosing Giant Cell Arteritis
A study testing CXCR4-PET in people with Vasculitis and Diagnoses Disease, run by Matthias Fröhlich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasculitis, Diagnoses Disease
- What is being tested?
- CXCR4-PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Contraindications for the performance of a PET CT examination
- Pregnancy
- Allergies
- Lack of capacity of the patient to give informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Departement of Internal Medicine II, Rheumatology/Clinical Immunology
Würzburg, Bavaria, 97074
About this study
Official title: Detection of Disease Activity in Giant Cell Arteritis Using CXCR4-PET/CT
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
- Being tested
- CXCR4-PET
- Keywords
- Vasculitis, LV-GCA, Giant cell arteritis, FDG-PET, Imaging, CXCR4
- Medical subject headings
- Vasculitis, Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXCR4-PETDiagnostic test
New imaging modality using CXCR4 for imaging in GCA
| Study group | Role | What they receive |
|---|---|---|
| CXCR4-PET experimental group | Experimental | In addition to the current standard of imaging in GCA, using FDG-PET/CT, participants receive CXCR4-PET. Receives: Diagnostic Test: CXCR4-PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
Correlation with blood leukocyte count
Correlation of tracer uptake on imaging with CXCR4-positive peripheral blood leukocyte count.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Oct 2021
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VasculitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Matthias Fröhlich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthias Fröhlich, Wuerzburg University Hospital
- Investigators
- Rudolf A Werner, MD, Study chair, University Hospital Würzburg Oberdürrbacherstrasse 6, 97080 Würzburg, Germany,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604482
- Sponsor's protocol ID
- CXCR4_PET_CT_RZA_V2.1
- Status last verified
- Dec 2023
- First submitted
- 30 Oct 2022
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Frohlich M, Serfling SE, Gernert M, Guggenberger K, Higuchi T, Gerhard-Hartmann E, Weich A, Samnick S, Schmalzing M, Bley TA, Buck AK, Werner RA. Establishing C-X-C motif chemokine receptor 4 as a novel imaging target in giant cell arteritis. Arthritis Res Ther. 2026 Feb 11;28(1):61. doi: 10.1186/s13075-026-03747-4.
PubMed 41668213
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Disease Activity in Giant Cell Arteritis Using CXCR4-PET/CT
- ClinicalTrials.gov ID
- NCT05604482
- Acronym / sponsor ID
- CXCR4_PET_CT_RZA_V2.1
- Conditions
- Vasculitis, Diagnoses Disease
- Keywords
- Vasculitis, LV-GCA, Giant cell arteritis, FDG-PET, Imaging, CXCR4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Matthias FröhlichUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CXCR4-PET experimental group | Experimental | Diagnostic Test: CXCR4-PETIn addition to the current standard of imaging in GCA, using FDG-PET/CT, participants receive CXCR4-PET. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- Contraindications for the performance of a PET CT examination
- Pregnancy
- Allergies
- Lack of capacity of the patient to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CXCR4-PETNew imaging modality using CXCR4 for imaging in GCA | Diagnostic test | CXCR4-PET experimental group |
Primary outcome
Maximum measurable tracer activity on 68Ga-Pentixafor PET/CT in the area of blood vessels in active GCA
Time frame: 2 years
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.
3 secondary outcomes
Correlation with clinical parameters
Time frame: 2 years
Correlation with blood leukocyte count
Time frame: 2 years
Comparison to other imaging modalities
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Derived from this study: PubMed 41668213Frohlich M, Serfling SE, Gernert M, Guggenberger K, Higuchi T, Gerhard-Hartmann E, Weich A, Samnick S, Schmalzing M, Bley TA, Buck AK, Werner RA. Establishing C-X-C motif chemokine receptor 4 as a novel imaging target in giant cell arteritis. Arthritis Res Ther. 2026 Feb 11;28(1):61. doi: 10.1186/s13075-026-03747-4.
- Individual participant dataSharing planned: No
Related trials for Vasculitis
Active, not recruitingPhase 2
Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Not yet recruitingPhase 3
Aspirin for the Prevention of Ischemic Complications in Giant Cell Arteritis
Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rudolf A Werner, MD study chair
University Hospital Würzburg Oberdürrbacherstrasse 6, 97080 Würzburg, Germany,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CXCR4-PET in people with Vasculitis and Diagnoses Disease, run by Matthias Fröhlich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum measurable tracer activity on 68Ga-Pentixafor PET/CT in the area of blood vessels in active GCA (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05604482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.