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临床试验/NCT01188486
NCT01188486终止不适用

Pulmonary Interstitial Lymphography in Early Stage Lung Cancer

Stanford University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

干预措施: Computed Tomography (CT) (Radiation)

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

干预措施: Cyberknife (Device)

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

干预措施: Trilogy (Device)

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

干预措施: True Beam (Device)

pulmonary interstitial lymphography

Experimental

stereotactic body radiation therapy & pulmonary interstitial lymphography

干预措施: Iohexol (Drug)

pulmonary interstitial lymphography

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Billy W. Loo Jr.

Associate Professor of Radiation Oncology

Stanford University

研究点 (1)

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