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

NCT07212959 | Completed

• 1 other identifier: 296/21-me
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

SSc; CXCR4; PET/CT

Outcome Measures

Primary Outcomes (1)

• Maximum Traceracktivity in CXCR4-PET/CT

  Measurement of the maximum measurable CXCR4 tracer activity in CXCR4 PET/CT in fibrotic pulmonal changes

  2 year

Study Arms (1)

CXCR4-PET/CT for detection von inflammatory changes in systemic sclerosis

EXPERIMENTAL

Other: CXCR4-PET/CT

Interventions

CXCR4-PET/CT OTHER

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

CXCR4-PET/CT for detection von inflammatory changes in systemic sclerosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead

Study Sites (1)

University Hospital Würzburg

Würzburg, Bavaria, 97078, Germany

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• MIcheal Armin Gernert, Privatdozent

  Wuerzburg University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 8, 2025
• Study Start: January 31, 2024
• Primary Completion: May 15, 2025
• Study Completion: May 31, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)