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

NCT03459898 — Not applicable, Completed, 40 participants, Sunnybrook Health Sciences Centre

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Registry	NCT03459898
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	40 (Actual)
Sponsor	Sunnybrook Health Sciences Centre (Other)
Conditions	Left-Sided Breast Cancer
Interventions	AlignRT system (VisionRT Ltd., London, UK) (Device)
Dates	start 2018-05-19, primary completion 2021-12-31, completion 2022-01-30, first posted 2018-03-09, last updated 2022-05-05
Locations	1 site in Canada

-Summary

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).

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+Arms and interventions

Arm	Type	Interventions	Description
Active Breathing Control	Other	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.
Deep Inspiration Breath Hold	Other	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.

AlignRT system (VisionRT Ltd., London, UK) (Device): 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.

+Outcome measures

Primary outcomes

Reproducibility of ABC or vDIBH set-up as measured by Align RT. [2 years]: 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.
Mean heart dose as determined using Align RT. [2 years]: 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.

Secondary outcomes

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. [2 years]: 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.

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Sunnybrook Health Sciences Centre	Toronto, Ontario	Canada

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