Hepatocellular Carcinoma Imaging Using PSMA PET/CT - a Prospective Pilot Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- True Positive Rate per lesion
研究概览
简要总结
The purpose of the research is to evaluate the use of a PSMA PET/CT (Prostate Specific Membrane Antigen Positron Emission Tomography/Computerized Tomography) scan in the diagnosis of HCC (hepatocellular carcinoma) and comparing it to standard scanning techniques with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging).
详细描述
A total of 30 patients will be recruited in this prospective pilot study who have HCC on imaging criteria (LI-RADS 5) for surgical resection, or patients with indeterminate liver lesions (LI-RADS 3 or 4) planned for liver biopsy. 18F-DCFPYL PSMA PET/CT will be performed prior to the planned surgery or liver biopsy
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
- •Male or female aged 18 years or older at screening
- •Has provided written informed consent for participation in the study
- •Must have risk factors for HCC e.g. cirrhosis, chronic hepatitis B infection with or without cirrhosis
- •Patients with liver lesions ≥1 cm suspicious for HCC but with indeterminate features on CT and MRI meeting LI-RADS 3 or 4 criteria planned for biopsy, OR patients with liver lesions diagnostic of HCC based on CT or MRI meeting LI-RADS 5 criteria planned for surgical resection
- •Patients must be willing and able to comply with the protocol and procedures for the duration of the study
- •Patients must be available for follow-up
排除标准
- •Abdominal surgery or radiotherapy to the abdomen within <4 weeks of registration. Patients must have recovered from any effects of any major surgery
- •Uncontrolled intercurrent illness that is likely to impede participation and or compliance
- •Any history of prostate cancer or elevated PSA level for male patients
- •Other malignancies unless curatively treated with no evidence of disease within previous 3-years other than adequately treated non-melanoma skin cancer or melanoma in situ
- •Participation in another clinical study with an investigational product or another systemic cancer therapy administered in the last 4 weeks
- •Has known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the study
- •Women who are pregnant or lactating
- •Cirrhosis due to congenital hepatic fibrosis, vascular disorders (e.g. Budd-Chiari syndrome) or cardiac cirrhosis
研究组 & 干预措施
18F-DCFPyL
Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL
干预措施: 18F-DCFPyL (Drug)
结局指标
主要结局
True Positive Rate per lesion
时间窗: 6 months
The probability that HCC is present when the PSMA-PET/CT test result is positive on a per lesion basis.
True Negative Rate per lesion.
时间窗: 6 months
The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per lesion basis.
True Positive Rate per patient
时间窗: 6 months
The probability that HCC is present when the PSMA-PET/CT test result is positive on a per patient basis.
True Negative Rate per patient
时间窗: 6 months
The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per patient basis.
次要结局
- PSMA expression.(6 months)
- GLUT-1 expression(6 months)
- PSMA uptake(6 months)
- Maximum standard uptake value(6 months)
- CT LIRADS (Liver Imaging Reporting and Data System) Score(6 months)