A Phase III, Multi-center, Single-blind, Cross-over Study to Evaluate the Efficacy and Safety of 18Ffluorocholine (18F-FCH) Comparing With 18F-fluorodeoxyglucose (18F-FDG) for Detecting Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The pathological diagnosis of the liver tumor will be compared with the test result of the PET/CT scan findings.
研究概览
简要总结
Liver cancer is a major cause of death among patients of east or southeast asian descent, as well as other population groups, notably in central and west Africa. Diagnosis of liver cancer requires a combination of several imaging techniques and biopsies. Despite this, diagnosis can remain inconclusive or difficult to establish in patients at risk for liver cancer.
The purpose of this multi-center trial is to evaluate novel imaging methods developed to diagnose the most common form of liver cancer, hepatocellular carcinoma. We propose to use novel imaging probes that have been reported to bind to liver cancers but not benign liver lesions that can be confused with liver cancer. Two such imaging probes will be evaluated. 2-[18F]-fluoro-2-deoxy-D-glucose, called [18F]FDG, is a radioactive sugar that is widely used for cancer imaging with a device called positron emission tomography, or PET scans. We already know that [18F]FDG cannot detect some liver cancers that are slow growing. [18F]Fluorocholine ([18F]FCH), another molecule, has been recently reported to be highly effective at detecting liver cancer. In 2010, a French researcher reported 80-90% detection rate by using [18F]FCH alone or in combination with [18F]FDG.
We will compare [18F]FCH and [18F]FDG in evaluating 150 patients over a period of two years. The results will be correlated with those of biopsies and clinical follow-up.
This study will provide valuable data on whether these imaging agents can successfully differentiate malignant liver lesions from benign ones. It will also provide information about whether these imaging agents can successfully assess whether the cancer has spread outside the liver. It will provide data that will allow physicians to determine the optimal imaging protocol to properly diagnose liver cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥ 20 years old.
- •Patient who accepts to enter the study by signing written informed consent.
- •Patient with performance status ≤ 2 Eastern Cooperative Oncology Group (ECOG).
- •Patient with cirrhosis or chronic liver diseases suspected to have at least 1 hepatic nodule larger than 1 cm in diameter detected by conventional image (US, CT, MRI). Patient who has not yet received any therapy relevant to the aforementioned diagnosis. Hepatic nodule is defined as any one of the following conditions: suspicious hepatocellular carcinoma, benign tumor such as hemangioma, adenoma or focal nodular hyperplasia, metastatic lesions from other primary malignancy.
- •Female patient must take reliable contraception method(s) during the participation of the study.
排除标准
- •Patient has serious allergic history or known allergy to 18F-FDG or 18F-FCH.
- •Patient has been diagnosed of multiple malignancies.
- •Female patient who is pregnant, lactating or planning to become pregnant during the study.
- •Patient has been participated in other investigational trials within 28 days prior to study enrollment.
- •Patient is unable to undergo PET/CT scan.
- •Subjects with active systemic infections, or medical conditions that may significantly affect action, adequate uptake and elimination of radiotracer.
- •Subject with conditions judged by the investigator as unsuitable for the study.
研究组 & 干预措施
FCH PET/CT scan results
PET/CT scan results with FCH intravenous injection
干预措施: 18F- fluorocholine (Drug)
FDG PET/CT scan
PET/CT scan results with FDG intravenous injection
干预措施: 18F- fluorodeoxyglucose (Drug)
结局指标
主要结局
The pathological diagnosis of the liver tumor will be compared with the test result of the PET/CT scan findings.
时间窗: Within 6 months of follow up after the PET/CT scans.
After the study cases finished the two PET/CT scans, the cases will be followed as long as 6 months thereafter. Within this time frame, the study cases will go for a patho-histological diagnosis of the liver tumor. This will be used as the primary outcome.
次要结局
未报告次要终点