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临床试验/NCT02379988
NCT02379988已完成不适用

Pilot Study For Prone Breath Hold Technique to Decrease Cardiac and Pulmonary Doses in Women Receiving Left Breast Radiotherapy

University of Arizona2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques.

研究概览

简要总结

This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receive for patients being treated for left sided breast cancer.

详细描述

Subjects have a standard of care CT simulation, which includes an additional breath hold CT. Inspiratory gated breath-hold will be used. Two radiation plans will be generated: one for the CT scan performed free breathing, and one for the CT scan performed with inspiratory gated breath hold. The cardiac and lung doses will be determined. At the discretion of the treating physician, the plan with the lower cardiac and lung dose may be used to treat the patient.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients of Dr. Gonzalez
  • ≥18 years of age
  • Node-negative left breast cancer
  • Invasive or DCIS breast cancer
  • Prior lumpectomy
  • Deemed appropriate for treatment in the prone position by the treating physician
  • Able to tolerate prone position and breath hold during CT simulation

排除标准

  • <18 years of age
  • Patients requiring treatment in supine position

结局指标

主要结局

The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques.

时间窗: Treatment Day 1 (both pFB and pDIBH scans were done on the same day)

The primary endpoints of this study were to evaluate the feasibility of the combination of prone positioning and RPM pDIPH for breast cancer radiation treatment. Each woman enrolled in the study had 2 radiation plans generated: one for the pFB scan and one for the pDIBH scan. The mean difference between the dosimetrically determined heart, left anterior descending (LAD) artery, and left lung radiation doses were computed with the associated 95% confidence interval; however, the Wilcoxin paired signed rank test was used and listed below as the primary analysis because of the non-normal distributions.

次要结局

  • Heart Mean Dose Based on Breast Volume(Treatment Day 1)
  • Determination of Left Anterior Artery (LAD) Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added.(Treatment Day 1)
  • Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added.(Treatment Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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