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临床试验/NCT02544945
NCT02544945已完成不适用

Comparing 3-D Printed vs Standard Bolus for Breast Cancer Chest Wall Radiotherapy: A Feasibility Study Measuring Bolus Spatial Accuracy, Dosimetric Accuracy and Treatment Set-up Time

Rob Rutledge2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Air gap under bolus

研究概览

简要总结

This is a cohort study of 16 women undergoing post-mastectomy chest wall radiotherapy for breast cancer comparing two ways of modifying the radiation beam with bolus (a 5mm rubber substance placed on the skin to modify the radiation beam). The hypothesis is that 3D printed bolus will conform more closely to the chest wall than standard 5mm-thick standard bolus and thus lead to less chance of underdose or overdose of the skin. Each patient will receive the standard dose of radiotherapy, but half the treatments will use standard bolus and half the treatments will 3D printed bolus (ie each patient will act as is their own control). The primary outcome is the comparison of the amount of air under the bolus for each technique. Secondary outcome is the amount of time it takes to set up the patient for radiotherapy.

详细描述

  1. Study Schema

Intervention

All subjects receive standard chest wall radiotherapy doses as follows:

  • Half the days no bolus is applied to the chest wall as per the standard of care
  • Half the days bolus is applied - alternating days between standard 5mm rubber bolus and the experimental 3D printed bolus.

Primary and Secondary Outcomes Each subject acts as their own control comparing the standard rubber bolus with the 3D printed bolus in terms of

  • The volume of air-gap between the bolus and the chest wall skin
  • The time it takes the radiation therapists to set up the patient
  • The calculated versus measured dose on the skin

Sample size 16 patients over 4 months 2. Background and Rationale

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

  • Women undergoing radiotherapy to the chest wall for the treatment of breast cancer with radical intent.

排除标准

  • Patients in whom the Radiation Oncologist plans to either omit bolus for more than half of the treatments (rarely happens).
  • Patients undergoing a non-standard chest-wall technique (eg. VMAT)
  • Pregnant or plans to get pregnant during radiotherapy
  • Inability to obtain informed consent or adhere to the protocol

研究组 & 干预措施

Standard Bolus

Active Comparator

The radiotherapy treatment days when the standard bolus is used

干预措施: Standard bolus (Other)

3D printed bolus

Experimental

the radiotherapy treatment days when the 3D bolus is used

干预措施: 3D printed bolus (Other)

结局指标

主要结局

Air gap under bolus

时间窗: Up to 3 month

Air gap is defined as a) the greatest distance from the skin to the bolus measured perpendicular to the chest wall, and b) the maximal area of skin underlying the maximal air pocket

次要结局

  • Set up time(Up to 3 months)

研究者

发起方
Rob Rutledge
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rob Rutledge

Staff Radiation Oncologist

Nova Scotia Health Authority

研究点 (2)

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