Assessment of Treatment-Induced Tissue Hypoxia After Transcatheter Arterial Embolization of Hepatocellular Carcinoma: A Feasibility Study With [18F]FMISO PET/CT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue
研究概览
简要总结
This clinical trial studies how well 18F-fluoromisonidazole ([18F]FMISO) positron emission tomography (PET)/computed tomography (CT) works after transcatheter arterial embolization in imaging tumors in patients with liver cancer. Transcatheter arterial embolization blocks blood flow to tumor cells by inserting tiny foreign particles into an artery near the tumor. [18F]FMISO is a type of radioimaging agent that binds to large molecules in tumor cells that have a low level of oxygen, and the radiation given off by [18F]FMISO is picked up by a PET scan and this may help researchers learn whether changes occur in the tumors after treatment, which can help decide how well the treatment worked earlier than is currently possible
详细描述
PRIMARY OBJECTIVES:
I. Determine the variability of 18F FMISO uptake in hepatocellular carcinoma (HCC) tumors compared to normal liver after transcatheter arterial embolization by determining the difference in the mean of the maximum standardized uptake value (SUVmax) and tumor-to-liver ratio (TLR) of a region of normal liver and of up to 5 index tumors.
SECONDARY OBJECTIVES:
I. Determine if areas of tumor recurrence as determined by CT or magnetic resonance imaging (MRI) within a 6 month period after transcatheter arterial embolization show evidence of increased 18F FMISO labeling on the initial post treatment 18F FMISO PET/CT.
II. Determine the variability in SUVmax and TLR of untreated (non embolized) HCC lesions compared to normal liver by determining the difference in the mean of the SUVmax and TLR of normal liver and tumor.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •Histopathologic or imaging and clinical features of tumor(s) diagnostic for hepatocellular carcinoma with at least one tumor >= 1.5 cm; imaging features diagnostic for hepatocellular carcinoma will be defined as Liver Imaging Reporting and Data System (LIRADS) 4 or greater
- •Total bilirubin < 3.0
- •Child Pugh A or B
- •Tumor amenable to transcatheter arterial embolization
- •Able to provide informed consent
排除标准
- •Uncontrolled large ascites
- •Main or segmental portal vein thrombosis
- •Locoregional treatment of hepatocellular carcinoma within the prior 3 months or chemotherapy within the previous 3 months
- •Inability or contraindication to undergo transcatheter arterial embolization
- •Inability to lay flat for at least 2 consecutive hours
- •Severe acute illness
- •Uncontrolled chronic illness such as hypertension, diabetes, or heart failure
- •Contraindication to CT or MRI contrast
- •Pregnancy
研究组 & 干预措施
Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)
Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.
干预措施: 18F-Fluoromisonidazole (Drug)
Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)
Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.
干预措施: Arterial Embolization (Procedure)
Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)
Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.
干预措施: Computed Tomography (Diagnostic Test)
Diagnostic (18F-fluoromisonidazole, PET/CT, embolization)
Patients undergo transcatheter arterial embolization. Patients also receive 18F-fluoromisonidazole IV and undergo PET/CT scans 4 weeks prior to embolization treatment and in the 20 hours following completion of treatment.
干预措施: Positron Emission Tomography (Diagnostic Test)
结局指标
主要结局
Post-treatment Maximum Standardized Uptake Value (SUVmax) in Tumor and Normal Tissue
时间窗: 24 hours
All participants undergo transcatheter arterial embolization (TACE) and 18F-fluoromisonidazole (18F-FMISO) positron emission tomography (PET)/computed tomography (CT) scans were conducted. Maximum standardized uptake value (SUVmax) were determined at the tumor lesion and in normal tissue, represented by liver. The variability of 18F-FMISO uptake in hepatocellular carcinoma (HCC) tumors post-TACE was assessed as the ratio of the SUVmax as observed in the tumor vs liver (tumor-to-liver ratio, TLR). The outcome is reported as the mean TLR, with standard deviation.
次要结局
- Maximum Standardized Uptake Value (SUVmax) at Lesion Sites With and Without Tumor Recurrence(Up to 6 months)
- Adverse Events Related to 18F-fluoromisonidazole (18F-FMISO)(18 hours)