Detection of Hepatocellular Carcinoma by Positron Emission Tomography With C-Acetate-11 and F-fluorodeoxyglucose-18
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18
研究概览
简要总结
RATIONALE: Imaging procedures, such as carbon-11 acetate positron emission tomography (PET) and fludeoxyglucose F 18 PET, may improve the ability to detect hepatocellular carcinoma (liver cancer) and allow doctors to plan the most effective treatment.
PURPOSE: This clinical trial is studying how well carbon-11 acetate PET and fludeoxyglucose F 18 PET work in detecting cancer in patients with liver cancer.
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
- •Biopsy-proved HCC (stage I and II by conventional staging) or one or more of the following in a patient with clinically documented cirrhosis:
- •AFP > 200 mg/dL;
- •A contrast-enhancing tumor mass (>1 cm) by CT or MRI; or
- •A tumor mass confirmed by arteriography.
- •Patient must provide written informed consent and have completed conventional imaging and staging before initiation of PET imaging.
排除标准
- •Pediatric patients under the age of 18 will be excluded from consideration from this study.
- •Patients with a known prior malignancy (with the exception of basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years will be excluded from entry into the study. However, patients with a prior HCC thought to have a new primary or recurrent HCC are eligible.
- •Pregnant and breastfeeding patients.
- •Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)
研究组 & 干预措施
PET scan (FDG-PET & 11C-acetate-PET)
Patients will undergo routine clinical FDG-PET and research 11C-acetate-PET prior to planned surgical resection of the lesion(s) or explantation of the liver.
干预措施: 18F-Fluorodeoxyglucose-PET (FDG-PET) (Procedure)
PET scan (FDG-PET & 11C-acetate-PET)
Patients will undergo routine clinical FDG-PET and research 11C-acetate-PET prior to planned surgical resection of the lesion(s) or explantation of the liver.
干预措施: 11Carbon-Acetate-PET (Procedure)
结局指标
主要结局
Relative sensitivity and specificity of positron emission tomography (PET) scanning with carbon-11 acetate and fludeoxyglucose F 18
次要结局
- Determine whether PET identifies additional sites of disease not detected by conventional imaging
- Obtain a preliminary estimate of the impact of PET on management of patients with HCC.