Systemic Sclerosis (SSc)
Conditions
Keywords
SSc, CXCR4, PET/CT
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.
Interventions
OTHERCXCR4-PET/CT
CXCR4-PET/CT for the detection of inflammatory activity in patient with active systemic sclerosis
Sponsors
Wuerzburg University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Traceracktivity in CXCR4-PET/CT | 2 year | Measurement of the maximum measurable CXCR4 tracer activity in CXCR4 PET/CT in fibrotic pulmonal changes |
Countries
Germany
Outcome results
None listed