A Single-blind Study to Evaluate the Efficacy and Safety of 18F-Fluorodeoxygalactose (18F-FDGal) Compared to 18F-Fluorodeoxyglucose (18F-FDG) to Detect Hepatocellular Carcinoma Via PET/CT in Patients With Cirrhosis or Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Sensitivity of 18F-FDGal in the diagnosis of HCC on per-patient basis
研究概览
简要总结
Liver cancer is one of the leading causes of cancer death among Asian men. If diagnosed early the disease is treatable with surgery. Current conventional imaging modalities have limitations to early detection. This study proposes to use 18F-FGal and 18F-FDG PET/CT scans to compare the clinical efficacy of diagnosing hepatocellular carcinoma (a type of liver cancer) using these PET/CT scans.
详细描述
Screening Visit Patients will undergo screening procedures for determining eligibility prior to the first PET/CT examination. For practical reasons and to avoid unnecessary travel for research subjects, the initial screening can be conducted by phone, and completed on the day that the first PET/CT examination is performed. However, the PET/CT scan will only be done for subjects that meet all the eligibility criteria and sign the consent form prior to the examination. All patients should have received the consent form by mail, email or fax, at least 24 hours prior to the screening visit.
Demographics Demographic data including date of birth, gender, height and weight information will be obtained.
Medical History and Concomitant Medications The general medical history up to 3 months of study entry (screening visit) should be recorded at the screening visit. The medical history should include procedural and surgical history within the past year. Cancer history should be recorded on a lifetime basis. Previous medications should be recorded up to 28 days prior to screening visit and up to 1 year for cancer treatment if any. All concomitant medications starting from enrollment of subjects should be recorded on subsequent visits for the PET/CT examinations.
Vital Signs Patient's vital signs will be measured including blood pressure, pulse rate and oxygen saturation, within 60 minutes before and 5-15 minutes after administration of the investigational product at PET/CT visits.
PET/CT Scans Patients who meet all eligibility requirements for entry into the study will undergo both an 18F-FDGal and 18F-FDG PET/CT examinations at the BCCA - Vancouver Centre's Functional Imaging Department. The two scans are to be performed on separate days and must be performed between 1 and 15 calendar days of each other. Each PET/CT scan will require approximately 3 hours of additional time from the subject above standard of care. The screening visit and informed consent, can be performed on the same day as the first PET/CT scan (and before the examination), will take approximately one hour.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥ 19 years of age.
- •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 disease suspected to have at least 1 hepatic nodule larger than 1 cm in diameter detected by conventional image (US, CT, MRI).
- •Hepatic nodule is defined as any one of the following conditions: suspicious hepatocellular carcinoma, benign tumor such as hemangioma, adenoma or focal nodular hyperplasia, possible metastatic lesions from other primary malignancy.
排除标准
- •Patient has serious allergic history or known allergy to 18F-FDGal or 18F-FDG.
- •Patient has received therapy for aforementioned diagnosis before the PET scans
- •Patient with known (proven) metastases from a prior malignancy
- •Patient has been diagnosed with multiple malignancies.
- •Female patient who is pregnant, lactating or planning to become pregnant during the study.
- •Patient has participated in other investigational trials within 28 days prior to study enrollment.
- •Inability to lie supine for the duration of the imaging studies.
- •Subject with active systemic infections, or medical conditions that may significantly affect adequate uptake and elimination of radiotracer.
- •Subject with conditions judged by the investigator as unsuitable for the study.
结局指标
主要结局
Sensitivity of 18F-FDGal in the diagnosis of HCC on per-patient basis
时间窗: 6 months
Determination of sensitivity of both exams when compared with pathology reports (if available) and compared with routine imaging (CT, MRI, US) if available. The treatment group will be declared superior if the lower limit of the 95% two-sided confidence interval of the difference of these two proportions is greater than 0.
次要结局
- Number of participants with 18F-FDGal-related adverse events as assessed by abnormal vital sign measurement(1 hour)
- Sensitivity of 18F-FDGal in the diagnosis of HCC on per-site basis(6 months)
- Specificity of 18F-FDGal in the diagnosis of HCC(6 months)