Back to resultsAssessment of Left-sided Cardiac Sparing Through the Use of 3-dimensional Surface Matching-based Deep Inspiration Breath Hold and Active Breathing Control
Primary Purpose
Left-Sided Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
AlignRT system (VisionRT Ltd., London, UK)
Sponsored by
About this trial
This is an interventional treatment trial for Left-Sided Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Sunnybrook Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Active Breathing Control
Deep Inspiration Breath Hold
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03459898
First Posted
February 2, 2018
Last Updated
May 3, 2022
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT03459898
Brief Title
Assessment of Left-sided Cardiac Sparing Through the Use of 3-dimensional Surface Matching-based Deep Inspiration Breath Hold and Active Breathing Control
Official Title
Assessment of Left-sided Cardiac Sparing Through the Use of 3-dimensional Surface Matching-based Deep Inspiration Breath Hold and Active Breathing Control
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 19, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left-Sided Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Breathing Control
Arm Type
Other
Arm Description
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.
Arm Title
Deep Inspiration Breath Hold
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AlignRT system (VisionRT Ltd., London, UK)
Intervention Description
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 Outcome Measure Information:
Title
Reproducibility of ABC or vDIBH set-up as measured by Align RT.
Description
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.
Time Frame
2 years
Title
Mean heart dose as determined using Align RT.
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessment of Left-sided Cardiac Sparing Through the Use of 3-dimensional Surface Matching-based Deep Inspiration Breath Hold and Active Breathing Control
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