NCT07212959Completed
As Part of a Pilot Study, Visualization of Inflammatory Activity in Systemic Sclerosis Using CXCR4 PET/CT
CXCR4-PET/CT for the Detection of Inflammatory Activity in Systemic Sclerosis
Source: ClinicalTrials.gov · Last updated 8 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 2 Oct 2025
- Start date
- 31 Jan 2024
- Primary completion date
- 15 May 2025
- Lead sponsor
- Wuerzburg University Hospital
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT07212959
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 31 Jan 2024 to the primary completion date, 15 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Following autologous stem cell transplantation
Other illness
- Presence of pulmonary hypertension
- Allergies to 68Ga-Pentixafor
Other
- Contraindications for performing a PET/CT scan - Pregnancy
- Breastfeeding
- Patient's inability to understand and give informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Würzburg Coordinator of this site? Confirm its status | Würzburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.