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临床试验/NCT07212959
NCT07212959已完成不适用

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

Wuerzburg University Hospital1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年1月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Maximum Traceracktivity in CXCR4-PET/CT

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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

Experimental

干预措施: CXCR4-PET/CT (Other)

结局指标

主要结局

Maximum Traceracktivity in CXCR4-PET/CT

时间窗: 2 year

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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