-------------------------- The BRAVEHeart (Breast Radiotherapy Audio Visual Enhancement for sparing the Heart) clinical trial data Current owners: Paul Keall and Shona Silvester, email paul.keall@sydney.edu.au and shona.silvester@sydney.edu.au -------------------------- Summary/Timeline -------------------------- -40 patients recruited -Two stages: -Stage 1, initial 13 patients - First patient start 24 Oct 2018 - Patient 13 completed 18 Sep 2019 -Interim analysis led to protocol changes allowing Breathe Well gating -Stage 2, patients 14-45 (extra patients for drop-out) - Patient 14 start 10 Mar 2021 - Final patient completed 15 Sep 2021 Patient 12 and Patient 31 data were not obtained. -------------------------- Publications: -------------------------- If using the data please Refer to the papers: Byrne, Hilary L., et al. "Prospective randomized trial comparing two devices for deep inspiration breath hold management in breast radiotherapy: Results of the BRAVEHeart trial." Advances in Radiation Oncology (2024) and Byrne, Hilary L., et al. "BRAVEHeart: a randomised trial comparing the accuracy of Breathe Well and RPM for deep inspiration breath hold breast cancer radiotherapy." Trials (2023) Rationale: The Deep Inspiration Breath Hold method for treating breast cancer treats patients as they hold a deep in-breath. This moves the chest wall and so the breast target away from the heart, reducing heart dose and risk of heart disease in later life. It has been shown that visual feedback can help patients maintain a reproducible and stable breath hold. This study aims to compare two visual biofeedback systems: Varian RPM/RGSC (standard of care) which tracks a marker block placed on the patients abdomen & Breathe Well (novel device) which uses direct optical surface monitoring of the patient's chest. Primary hypothesis: The accuracy of ‘Breathe Well’ will be superior to the RPM system, because ‘Breathe Well’ is tracking the chest directly, while the RPM system uses a marker block on the upper abdomen as a surrogate for chest motion. Clinical Trial Documentation: The BRAVEHeart clinical trial documents are stored on OneDrive: "ACRF Image X Institute - Documents\Clinical Trials\BRAVE HEART" or in the University of Sydney eScholarship repository. See current protocol document for more background, in sub-folder "3.0 Protocol"; See "18.0 Study Manuals" folder for operation manual/QA/etc documents for the Breathe Well device produced for use at Royal North Shore Hospital for stage 1 of the study. -------------------------- Data Summary -------------------------- Raw data in folders: RawPatientData/P (Anonymised)/BreatheWell - Respiratory traces from Breathe Well device - from CT simulation, process involves setting the breath hold depth (RespInfo_DIBHSim.txt, RespTrace_Sim.txt, RespTrace_Sim.txt) - trace captured for the entire treatment fraction (RespInfo_DIBH.txt, RespTrace_Sim.txt) RawPatientData/P (Anonymised)/RPM - Respiratory traces from Varian RPM abdominal block monitoring - Stage 1 (RPM): from the entire fraction, motion trace (**.vxp) and database file containing the breath hold depth/baselining info (**.dat) - Stage 2 (RGSC): data only recorded when MV beam is enabled - baselined motion trace (**.txt) RawPatientData/P (Anonymised)/iTools - Cine EPID images (MV beam's eye-view imaging) during treatment - Stage 2 only (see below, Stage 1 analysed at RNSH) RawPatientData/P (Anonymised)/DRR (BH_PhysOnly) - Stage 2 only, anonymised DRR exported from ARIA with custom filter to approximate MV image. Needed for MV image processing. RawPatientData/P (Anonymised)/Plan - Stage 2 only, anonymised RT plan exported from ARIA. Needed for MV image processing. RawPatientData/MVAnlysis - Stage 1 only - results of MV image data analysis at RNSH to produce a ground truth chest wall movement. -------------------------- Data Storage/Access Statements: -------------------------- 1. copied from clinical trial protocol v2 Collected respiratory data (‘Breathe Well’ and RPM), CT images, MV frames from during the irradiation, and demographic information will be collected from the subjects. At the randomisation stage of the study, patients will receive a trial ID. The data saved for the trial will be under this de-identified trial ID. A separate key of the subject study number and their medical record number will be securely stored by the chief investigator to allow re-identification if necessary. This master list for re-identification will remain at the Royal North Shore Hospital. Only the principal investigator will have the ability to re-identify subjects. The data will be stored for 15 years as per clinical trial guidelines. Data sent from the Northern Sydney Cancer Centre, Royal North Shore Hospital in accordance with the study site’s ethics and security allowances and protocols to the study site University of Sydney will be anonymised but re-identifiable. Patient data could be made re-identifiable to obtain additional clinical information for the data analysis stage of the project, but only by the principal investigator. The de-identified data will be stored at the University of Sydney on a secure, password protected backed up database that will be created, much the same as what we have designed for previous University of Sydney studies. Only non-identifiable data may be available for other scientific research, e.g., non-identifiable data placed on a well-controlled university site, upon request. The data sharing platform is a secure on-line storage solution ("CloudStor") provided through University of Sydney. The data will be stored as a password-protected, encrypted Zip-file. In order to download / decompress the data, participating researchers agree to the terms of use for the data, including: (I) that the data is not to be published or otherwise redistributed without the express consent of the original investigator(s) and (ii) that the data is forbidden to be used for any commercial purpose. -------------------------- 2. copied from the Patient Informed Consent document ‘What happens with the results?’ If you give us your permission by signing the consent document, we plan to discuss/publish the results in peer reviewed journals and at conferences. In publications and conference presentations, information will be provided in such a way that you cannot be identified. The results of this research will be provided to you, if you wish. Data collected from you in this study will be stored in a departmental database with a coded participant number at the Royal North Shore Hospital. Your de-identified data will be securely stored at the University of Sydney. Your data may be used for future research into breast cancer. We will maintain your confidentiality by applicable privacy measures. Your non-identifiable data will be stored perpetually in our secure database, the ‘CloudStor’ at the University of Sydney. This is not optional. If you do not wish your data to be stored for future research, then you should not participate in this study. Your stored data will only be used in future research under the approval of a Human Research Ethics Committee. -------------------------- Data processing code: -------------------------- Accuracy analysis code written in matlab - see https://github.sydney.edu.au/Image-X/BRAVEHeartAnalysis