Analyse of Diagnosis Value of Keloid on 68Ga- FAPI-04 PET-CT
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Diagnostic value
研究概览
简要总结
Keloid scars are common benign fibroproliferative reticular dermal lesions. Fibroblasts are considered to be the key cellular mediators of fibrogenesis in keloid scars. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may provide evidence for diagnosis and evaluate the effectiveness of treatment.
详细描述
Keloid scars are common benign fibroproliferative reticular dermal lesions with unknown etiology and ill-defined management with a high rate of recurrence post-surgery. The progression of keloids is characterized by increased deposition of extracellular matrix proteins, invasion of the surrounding healthy skin, and inflammation.
Fibroblast activation protein alpha (FAP-a) and dipeptidyl peptidase IV(DPPIV) are proteases located at the plasma membrane promoting cell invasiveness and tumor growth and have been previously associated with keloid scars. Thus this prospective study is going to investigate whether 68Ga-FAPI PET/CT may be superior for diagnosis, therapy response assessment, and follow-up of keloid.
This study aims to explore whether FAP plays a role in the mechanisms of scar tissue progression, as well as the diagnostic efficacy of these two imaging agents, and to be able to evaluate relevant treatments for personalized therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected or confirmed pulmonary fibrosis patients;
- •signed written consent.
排除标准
- •pregnancy;
- •breastfeeding;
- •known allergy against FAPI
- •any medical condition that in the opinion of the investigator may significantly interfere with study compliance
研究组 & 干预措施
68Ga-FAPI-04 PET/CT
All patients diagnosed with keloid underwent 68Ga-FAPI PET/CT.
干预措施: 68Ga-FAPI (Drug)
结局指标
主要结局
Diagnostic value
时间窗: through study completion, an average of 1 year
Sensitivity and Specificity of 68Ga-FAPI PET/CT for Lung fibrosis in comparison with 68Ga-RGD PET/CT
次要结局
- FAPI expression and SUV(through study completion, an average of 1 year)
- therapy response(through study completion, an average of 1 year)