BRAVEHeart: a randomised trial comparing the accuracy of Breathe Well and RPM for deep inspiration breath hold breast cancer radiotherapy

Trials

Study Protocol

Kuldeep Makhija¹  Paul Keall¹  Shona Silvester¹  Natalie Plant¹  Hilary L. Byrne¹  Elisabeth Steiner²  Marita Morgia³  Leigh Ambrose³  Cameron Stanton³  Regina Bromley³  John Atyeo³  Gillian Lamoury³  Benjamin Zwan³  Kylie Richardson³  Jeremy Booth⁴ 

[1] ACRF Image X Institute, School of Health Sciences, The University of Sydney, Sydney, Australia;LK Wiener Neustadt, Wiener Neustadt, Austria;Northern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia;Northern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia;School of Physics, The University of Sydney, Sydney, Australia;

关键词: Breast cancer;    Radiotherapy;    Deep inspiration breath hold;    Motion monitoring;    Visual feedback;    Surface monitoring;   

DOI  :  10.1186/s13063-023-07072-y

 received in 2021-08-04, accepted in 2023-01-03,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundDeep inspiration breath hold (DIBH) reduces radiotherapy cardiac dose for left-sided breast cancer patients. The primary aim of the BRAVEHeart (Breast Radiotherapy Audio Visual Enhancement for sparing the Heart) trial is to assess the accuracy and usability of a novel device, Breathe Well, for DIBH guidance for left-sided breast cancer patients. Breathe Well will be compared to an adapted widely available monitoring system, the Real-time Position Management system (RPM).MethodsBRAVEHeart is a single institution prospective randomised trial of two DIBH devices. BRAVEHeart will assess the DIBH accuracy for Breathe Well and RPM during left-sided breast cancer radiotherapy. After informed consent has been obtained, 40 patients will be randomised into two equal groups, the experimental arm (Breathe Well) and the control arm (RPM with in-house modification of an added patient screen). The primary hypothesis of BRAVEHeart is that the accuracy of Breathe Well in maintaining the position of the chest during DIBH is superior to the RPM system. Accuracy will be measured by comparing chest wall motion extracted from images acquired of the treatment field during breast radiotherapy for patients treated using the Breathe Well system and those using the RPM system.DiscussionThe Breathe Well device uses a depth camera to monitor the chest surface while the RPM system monitors a block on the patient’s abdomen. The hypothesis of this trial is that the chest surface is a better surrogate for the internal chest wall motion used as a measure of treatment accuracy. The Breathe Well device aims to deliver an easy-to-use implementation of surface monitoring. The findings from the study will help inform the technology choice for other centres performing DIBH.Trial registrationClinicalTrials.govNCT02881203. Registered on 26 August 2016.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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