FAP-1 Study: FAPi PET in Pancreatic Ductal Adenocarcinoma: A Prospective, Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Imaging validation of Ga-68 FAPi PET/CT
研究概览
简要总结
Pancreatic adenocarcinoma commonly referred to as pancreatic cancer is a cancer which is known to involve the pancreas and the surrounding structures like blood vessels, which makes it an aggressive cancer. Treatment of the cancer is decided by how much the disease has spread. It has been understood from recent studies that there are some components of the tumor which are not detected by standard CT scan. The tissue in the tumor microenvironment leads to further spread of tumor. The tissue which is seen near the tumor has many attachments on the surface which are currently being studied. One of the most common attachments is Fibroblast activation protein (FAP), which is seen on the surface of tumor tissue. A radioactive tracer Gallium-68 is attached to a small protein known as 'peptide' named 'FAP inhibitor (FAPi)' which shall bind to FAP. Then a PET scan will be performed which shall help in understanding how much of the tissue is seen on the scan in addition to the pancreatic tumor. The investigators shall assess whether the radiotracer (Gallium-68 labeled FAPi) binds to other sites like liver or other organs where the cancer is likely to spread. From the study, the investigators shall study whether the new scanning technique is beneficial as compared to the standard CT scanning. Hence, the investigators would perform Gallium-68-labeled FAPi PET scan in addition to the standard CT scan and compare the results.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Any gender with age more than 18 years
- •Patients with biopsy-proven pancreatic ductal adenocarcinoma
- •Patient willing to participate in study
排除标准
- •Patient with concurrent malignancy
- •Pregnancy and lactation
研究组 & 干预措施
Study Arm 1: Patients who have been diagnosed with pancreatic ductal adenocarcinoma will undergo Ga-
Patients with pancreatic ductal adenocarcinoma who undergo standard work-up with histopathology and conventional imaging will be referred for Ga-68 FAPi PET/CT
干预措施: Ga-68 FAPi PET/CT (Diagnostic Test)
Study Arm 2: Treated patients with pancreatic ductal adenocarcinoma showing rising tumor markers (CA
Patients who undergo surgery or upfront chemotherapy and subsequently have rising tumor marker levels
干预措施: Ga-68 FAPi PET/CT (Diagnostic Test)
结局指标
主要结局
Imaging validation of Ga-68 FAPi PET/CT
时间窗: 6 and 12 months
To calculate sensitivity, specificity, positive predictive value and negative predictive value of quantitative and semi-quantitative parameters on FAPi PET
次要结局
未报告次要终点
研究者
Ameya Puranik
Professor
Tata Memorial Hospital
