Pulmonary Interstitial Lymphography in Early Stage Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- - Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting
研究概览
简要总结
The stereotactic body radiation therapy (SBRT) procedure is an emerging alternative to the standard treatment for early stage non-small cell lung cancer (NSCLC), typically lobectomy with lymphadenectomy. This procedure (lobectomy) does not fulfill the medical need as many patients are poor operative candidates or decline surgery.
This study assesses the feasibility of stereotactic body radiation therapy (SBRT) as a tool to produce therapeutically useful computed tomography (CT) scans, using standard water-soluble iodinated compounds as the contrast agents.
详细描述
Non-small cell lung cancer (NSCLC) is the most deadly cancer in the world. NSCLC annually causes 150,000 deaths in the US and greater than 1 million worldwide. The standard treatment for early stage NSCLC is lobectomy with lymphadenectomy. However, many patients are poor operative candidates or decline surgery. An emerging alternative is Stereotactic Body Radiation Therapy (SBRT). Mounting evidence from phase 1-2 studies demonstrates that SBRT offers excellent local control. Most SBRT trials focused on small, peripheral tumors in inoperable patients. Increasingly, clinical trials study SBRT in operable patients, often with larger, central tumors.
Using clinical staging, a significant proportion of patients harbor occult nodal metastases when undergoing SBRT to the primary tumor alone. Subgroups of patients carry even higher risk of nodal metastases. These nodal metastases frequently would be removed by surgical intervention. However, SBRT, at present, is only directed at the primary tumor, potentially leading to regional failures in otherwise curable patients. To increase the effectiveness of SBRT for lung tumors, the next logical step is to explore whether the highest risk areas of disease spread can be identified and targeted. Regional failure could be reduced and outcome improved in a significant proportion of patients treated with SBRT if the primary nodal drainage (PND) were identified, targeted and treated in addition to the primary tumor.
We propose to conduct a study to determine the feasibility of visualizing, by computed tomography (CT) scans, water-soluble iodinated contrast materials after direct injection into the tumor. Integration into radiation therapy treatment planning may also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
pulmonary interstitial lymphography
stereotactic body radiation therapy & pulmonary interstitial lymphography
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
pulmonary interstitial lymphography
stereotactic body radiation therapy & pulmonary interstitial lymphography
干预措施: Computed Tomography (CT) (Radiation)
pulmonary interstitial lymphography
stereotactic body radiation therapy & pulmonary interstitial lymphography
干预措施: Cyberknife (Device)
pulmonary interstitial lymphography
stereotactic body radiation therapy & pulmonary interstitial lymphography
干预措施: Trilogy (Device)
pulmonary interstitial lymphography
stereotactic body radiation therapy & pulmonary interstitial lymphography
干预措施: True Beam (Device)
pulmonary interstitial lymphography
stereotactic body radiation therapy & pulmonary interstitial lymphography
干预措施: Iohexol (Drug)
pulmonary interstitial lymphography
stereotactic body radiation therapy & pulmonary interstitial lymphography
干预措施: Iodixanol (Drug)
结局指标
主要结局
- Feasibility and safety of identification of primary nodal drainage for purpose of radiation therapy targeting
时间窗: 15 months
次要结局
- - Feasibility of incorporating primary nodal drainage into radiation therapy planning process(15 months)
研究者
Billy W. Loo Jr.
Associate Professor of Radiation Oncology
Stanford University
