Feasibility of 11C-acetate in the Monitoring of Treatment Response Following Radiotherapy in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate
研究概览
简要总结
It is thought that PET of the abdomen with 11C Acetate will provide new information regarding whether or not patient's have benefited from radiotherapy. To test this theory, the project will evaluate the potential of 11C acetate to serve as an earlier and/or better signal of treatment success.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •> 18 years of age
- •Subject is willing to participate in the study and has signed the study informed consent
- •Subject is available and willing to comply with the protocol evaluations
- •Diagnosed hepatocellular carcinoma confined to a single lobe of the liver if undergoing 90Y radioembolization
- •Diagnosed hepatocellular carcinoma confined to the liver if undergoing Stereotactic Body Radiation Therapy (SBRT)
- •Under consideration for 90Y radioembolization or Stereotactic Body Radiation Therapy (SBRT)
排除标准
- •Pregnant or planning to become pregnant within the next 12 months or breast-feeding
- •GFR < 45
- •Life expectancy < 6 months
- •Claustrophobic and cannot tolerate imaging procedures
- •Weigh > 350 lb (upper weight limit of scanner beds)
- •Special vulnerabilities (e.g. fetuses, neonatales, pregnant women, children, prisoners, institutionalized individuals).
研究组 & 干预措施
Radiotherapy treatment monitoring of hepatocellular carcinoma
All patients enrolled in the trial will undergo 3 PET/CT studies using 11C-acetate at the injected radiotracer. The patients will be imaged prior to their radiation therapy and at 1 and 3 months following the completion of their radiation therapy. They will also undergo an MRI scan of the liver at each of those time points.
干预措施: 11C-Acetate (Drug)
结局指标
主要结局
To Compare Changes in 11C-acetate Uptake at One and Three Months Following Radiotherapy With Pre-treatment Uptake of 11C-acetate
时间窗: At three months
The single patient enrolled in the trial showed no uptake in the liver tumor on the pretreatment scan and was dropped from the trial.
次要结局
未报告次要终点
研究者
Justin Sims
Assistant Professor of Clinical Radiology
Indiana University