Systemic Sclerosis (SSc)NCT07212959
As Part of a Pilot Study, Visualization of Inflammatory Activity in Systemic Sclerosis Using CXCR4 PET/CT
A study testing CXCR4-PET/CT in people with Systemic Sclerosis (SSc), run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
Systemic sclerosis (SSc) is a heterogeneous clinical picture consisting of inflammatory, vasculopathic, and fibrotic changes. Initially, inflammatory changes usually occur, which result in fibrosis over time. This affects various organ systems such as the lungs, skin, heart, and gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc)
- What is being tested?
- CXCR4-PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2024to 31 May 2025
- 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
- Confirmed diagnosis of SSc based on the 2013 ACR/EULAR criteria
- Duration of disease less than 5 years (onset of the first non-Raynaud's symptom within the last 5 years)
- Evidence of ILD on computed tomography
- Patient's ability to understand the information provided
- Patient of legal age
Who cannot join
- Following autologous stem cell transplantation
- Presence of pulmonary hypertension
- Contraindications for performing a PET/CT scan - Pregnancy
- Breastfeeding
- Allergies to 68Ga-Pentixafor
- Patient's inability to understand and give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CXCR4-PET/CT for the Detection of Inflammatory Activity in Systemic Sclerosis
Systemic sclerosis (SSc) is a heterogeneous clinical picture consisting of inflammatory, vasculopathic, and fibrotic changes.
Initially, inflammatory changes usually occur, which result in fibrosis over time.
This affects various organ systems such as the lungs, skin, heart, and gastrointestinal tract. Early detection of inflammatory activity is therefore important in order to prevent consequential damage, in particular irreversible fibrosis. Since the inflammatory foci can spread throughout the entire body, there is a need to be able to detect inflammatory activity over a large area. The 68Ga-Pentiafor-based imaging of the CXCR4 chemokine receptor, which is expressed on immune system cells such as lymphocytes and macrophages, among others, offers a useful approach here, as it allows specific inflammatory cells that migrate to inflammatory lesions via the corresponding ligand (CXCL12) and are involved in the pathogenesis of SSc. To date, only chest CT has been used to diagnose and monitor the progression of pulmonary fibrosis in SSc. This non-functional imaging makes it virtually impossible to draw conclusions about inflammatory activity.
- Conditions
- Systemic Sclerosis (SSc)
- Being tested
- CXCR4-PET/CT
- Keywords
- SSc, CXCR4, PET/CT
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CXCR4-PET/CTOther
CXCR4-PET/CT for the detection of inflammatory activity in patient with active systemic sclerosis
| Study group | Role | What they receive |
|---|---|---|
| CXCR4-PET/CT for detection von inflammatory changes in systemic sclerosis | Experimental | Not described Receives: Other: CXCR4-PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Traceracktivity in CXCR4-PET/CT
Measurement of the maximum measurable CXCR4 tracer activity in CXCR4 PET/CT in fibrotic pulmonal changes
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start31 Jan 2024
- Primary completion15 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MIcheal Armin Gernert, Privatdozent, Study director, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212959
- Sponsor's protocol ID
- 296/21-me
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CXCR4-PET/CT for the Detection of Inflammatory Activity in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07212959
- Acronym / sponsor ID
- 296/21-me
- Conditions
- Systemic Sclerosis (SSc)
- Keywords
- SSc, CXCR4, PET/CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 8 Oct 2025 (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.
Systemic sclerosis (SSc) is a heterogeneous clinical picture consisting of inflammatory, vasculopathic, and fibrotic changes.
Initially, inflammatory changes usually occur, which result in fibrosis over time.
This affects various organ systems such as the lungs, skin, heart, and gastrointestinal tract. Early detection of inflammatory activity is therefore important in order to prevent consequential damage, in particular irreversible fibrosis. Since the inflammatory foci can spread throughout the entire body, there is a need to be able to detect inflammatory activity over a large area. The 68Ga-Pentiafor-based imaging of the CXCR4 chemokine receptor, which is expressed on immune system cells such as lymphocytes and macrophages, among others, offers a useful approach here, as it allows specific inflammatory cells that migrate to inflammatory lesions via the corresponding ligand (CXCL12) and are involved in the pathogenesis of SSc. To date, only chest CT has been used to diagnose and monitor the progression of pulmonary fibrosis in SSc. This non-functional imaging makes it virtually impossible to draw conclusions about inflammatory activity.
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/CT for detection von inflammatory changes in systemic sclerosis | Experimental | Other: CXCR4-PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of SSc based on the 2013 ACR/EULAR criteria
- Duration of disease less than 5 years (onset of the first non-Raynaud's symptom within the last 5 years)
- Evidence of ILD on computed tomography
- Patient's ability to understand the information provided
- Patient of legal age
Key exclusion criteria (6 listed)
- Following autologous stem cell transplantation
- Presence of pulmonary hypertension
- Contraindications for performing a PET/CT scan - Pregnancy
- Breastfeeding
- Allergies to 68Ga-Pentixafor
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-PET/CTCXCR4-PET/CT for the detection of inflammatory activity in patient with active systemic sclerosis | Other | CXCR4-PET/CT for detection von inflammatory changes in systemic sclerosis |
Primary outcome
Maximum Traceracktivity in CXCR4-PET/CT
Time frame: 2 year
Measurement of the maximum measurable CXCR4 tracer activity in CXCR4 PET/CT in fibrotic pulmonal changes
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 8 Oct 2025.
- Individual participant dataSharing planned: No
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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.
MIcheal Armin Gernert, Privatdozent study director
Wuerzburg University Hospital
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/CT in people with Systemic Sclerosis (SSc), run by Wuerzburg University Hospital 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 5 inclusion and 6 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 8 Oct 2025. 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 Traceracktivity in CXCR4-PET/CT (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2025.