FAPI PET/CT Imaging for Cancer: A Prospective Interobserver Agreement Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Agreement among observer groups in interpreting FAPI PET/CT scans
研究概览
简要总结
The aim of the present study is to evaluate the interobserver agreement for FAPI PET/CT interpretations of representative cancer types and compare findings among readers with different levels of experience.
详细描述
Fibroblast activation protein (FAP) is expressed by many cancer-associated fibroblasts, having a pivotal role in many desmoplastic tumor histotypes (sarcoma, pancreatic cancer, colorectal cancer). 68Ga-FAPI inhibitor (FAPI) is a promising novel molecular imaging tracer for positron emission tomography with computed tomography (PET/CT), with favorable initial results in different tumor entities. Compared to 18F-FDG, 68Ga-FAPI PET/CT shows a similar biodistribution, with less background tracer uptake in the brain, oral mucosa and liver, thus making this tracer potentially suitable to detect tumor lesions in these regions.
Moreover, the FAPI ligand contains a DOTA peptide which makes it appropriate also for therapeutic options if linked with 177Lutetium or 90Yttrium.
There is an increasing number of trials aimed to assess the efficacy and the clinical impact of 68Ga-FAPI PET/CT. Therefore, the inter-observer agreement and variability with 68Ga-FAPI PET/CT need to be established.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Agreement among observer groups in interpreting FAPI PET/CT scans
时间窗: 3 Months
Number of concordant scans among observer groups. Each scan will be rated as positive, negative or suspicion. For each scan all definite and suspicious lesions will be reported as well. Observer's reports data will be compared with an Expert Reading, which includes lesion validation, if applicable (i.e. imaging, laboratory, histopathology).
次要结局
- Agreement among observer groups in interpreting TNM stage and semi-quantitative values.(3 Months)
研究者
PD Dr. med. Wolfgang Fendler
Principal Investigator
University Hospital, Essen