跳至主要内容
临床试验/NCT00658281
NCT00658281已完成不适用

A Pilot Study of Setup Variation in the Supraclavicular Lymph Nodes Treatment in Breast Cancer Patients Using On-Board Imaging System With Linear Accelerator

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
System Failure (defined as 2 or more disagreements between the EPID and either OBI systems or CT-on-rail from among the 5 evaluations for a particular patient)

研究概览

简要总结

The goal of this clinical research study is to use the On Board Imager kilovoltage (OBI KV) system and cone beam computed tomography (CBCT) scanning or CT-on-rail system to look at how well a routine device called an electronic portal imaging device (EPID) can set up a patient to receive radiation therapy on the lymph nodes in the neck.

详细描述

The Study Imaging Techniques for Radiation Treatment Planning:

The standard way to set up a patient to receive radiation therapy on the lymph nodes in the neck is by using an EPID, which uses high-energy X-rays to make images to see if the patient's body positioning for radiation therapy is correct or not. It is important for the doctors to see the position of the patient's lower neck so that radiation can be delivered to the right place.

The position of the patient's body during radiation therapy is typically checked once a week using an EPID or a similar device. While the patient is lying on the treatment table, the EPID system takes the necessary images. In this study, along with using an EPID, researchers will use the OBI KV system and CBCT scanning, in order to look at how well the standard EPID is describing the patient's neck position.

OBI KV imaging is designed to make images using low-energy X-rays, and the images are considered reasonably clear and easy for the doctors to read. CBCT scanning uses low-energy X-rays that let the doctors see the lymph nodes in the lower neck. Unlike regular CT scanning, CBCT scanning does not require "contrast" material to be used.

Since all 3 of the pieces of equipment (the EPID, OBI KV, and CBCT systems) are built into the same treatment machine, you will not need to move for the extra pieces of equipment that are being used in this study. You will lay very still, as usual, and the images will all be taken in a row.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Histologically confirmed carcinoma of the breast.
  • American Joint Committee on Cancer (AJCC) Stage I-III, or locally recurrent breast cancer
  • Planned for radiation treatment of the supraclavicular and axillary apex nodal beds using a SCV field
  • Age greater than or equal to 18 years, since classic breast cancer is a disease of adults
  • Able to understand the current trial and give informed consent

排除标准

  • Has bilateral breast cancer requiring radiation to both breasts due to anatomic constraints on planning CT
  • inflammatory carcinoma due to altered treatment schedule

结局指标

主要结局

System Failure (defined as 2 or more disagreements between the EPID and either OBI systems or CT-on-rail from among the 5 evaluations for a particular patient)

时间窗: CBCT scanning and OBI R or CT-on-rial system, 5 evaluations per patient, during 5-week radiation treatment period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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