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Completed

NCT Number: NCT03459898

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).

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Key information

Conditions

Left-Sided Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Unilateral Breast Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Reproducibility of ABC or vDIBH set-up as measured by Align RT.

    Time frame: 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.

  2. Mean heart dose as determined using Align RT.

    Time frame: 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

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Mar 9, 2018
Registry last updated
May 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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