Assessment of Left-sided Cardiac Sparing Through the Use of 3-dimensional Surface Matching-based Deep Inspiration Breath Hold and Active Breathing Control

The standard treatment for breast cancer is surgery followed by adjuvant breast radiation therapy in most cases. For left sided breast cancers, the heart dose delivered by the radiation treatment is often of particular concern. In order to spare the heart, different strategies are currently available, including active breathing control (ABC) and voluntary deep in inspiration breath hold (DIBH) (both strategies are currently being used at our centre). To perform accurate heart-sparing treatments, it is important to ensure that patients are positioned consistently. One available approach is through surface imaging which tracks the position of a portion of the skin surface, known as the AlignRT system (VisionRT Ltd, London, UK).

Study Overview

• Status: Completed
• Conditions: Left-Sided Breast Cancer
• Intervention / Treatment: Device: AlignRT system (VisionRT Ltd., London, UK)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women with diagnosis of left-sided breast malignancy
• Women who require left chest wall or breast irradiation status post mastectomy or lumpectomy
• Treatment with modified wide tangents to include IMCs
• Treatment with four-field technique
• Age >18 years
• Performance status ECOG <3
• Patient must be able to maintain a 30 second breath hold
• Conventional chest wall or breast radiation delivery dose of 50Gy/25 or hypofractionated chest wall/breast radiation delivery dose of 42.56Gy/16 with or without a boost

Exclusion Criteria:

• Right sided breast cancer patients
• Treatment with partial breast irradiation
• Previous left breast/chest wall irradiation
• Locally advanced breast cancer
• Pregnant patients
• Unable to follow commands

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Active Breathing Control; To review our institutional clinical experience of applying the AlignRT system to monitor patient setup and reproducibility when using ABC and DIBH techniques in the treatment of left-sided breast cancer patients.	Device: AlignRT system (VisionRT Ltd., London, UK); To review our institutional clinical experience of applying the AlignRT system to monitor patient setup and reproducibility when using ABC and DIBH techniques in the treatment of left-sided breast cancer patients.
Other: Deep Inspiration Breath Hold; To review our institutional clinical experience of applying the AlignRT system to monitor patient setup and reproducibility when using ABC and DIBH techniques in the treatment of left-sided breast cancer patients.	Device: AlignRT system (VisionRT Ltd., London, UK); To review our institutional clinical experience of applying the AlignRT system to monitor patient setup and reproducibility when using ABC and DIBH techniques in the treatment of left-sided breast cancer patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of ABC or vDIBH set-up as measured by Align RT.	Reproducibility of set-up will be evaluated by determining discrepancies in patient's surface between treatment and CT simulation which will be acquired with the Align RT system using multiple measures along with daily portal images during treatment and weekly CBCTs.	2 years
Mean heart dose as determined using Align RT.	Estimate the change in mean heart dose for each breath-hold/heart sparing strategy by: i. Converting differences in heart position on 2D portal images acquired during treatment to 3D volumes on Pinnacle plans. ii. Using the CBCT images (acquired weekly), to recalculate dose to heart based on the patient's position and anatomy that day.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The impact of Align RT with vDIBH as compared to vDIBH without AlignRT on quality of life as assessed by the EORTC core QoL questionnaire.	QoL will be assessed using the EORTC core QoL questionnaire (QLQ-C30) which is a well-validated and widely used QoL questionnaire available in multiple languages (12,13). QLQ-C30 is composed of 30 questions that represent 5 functional scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), and a global health / QoL scale. The questionnaire will be completed by patients at time of radiation simulation as baseline, at completion of RT (during routine review) and at the 6-8 week follow-up.	2 years

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 5, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Unilateral Breast Neoplasms
• Other Study ID Numbers: 268-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No