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OpenTrials
Completed

NCT Number: NCT07212959

As Part of a Pilot Study, Visualization of Inflammatory Activity in Systemic Sclerosis Using CXCR4 PET/CT

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Würzburg

Würzburg, Bavaria, 97078, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CXCR4-PET/CT

Other

CXCR4-PET/CT for the detection of inflammatory activity in patient with active systemic sclerosis

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

CXCR4-PET/CT for the Detection of Inflammatory Activity in Systemic Sclerosis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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