Left-Sided Breast CancerNCT03459898
Assessment of Left-sided Cardiac Sparing Through the Use of 3-dimensional Surface Matching-based Deep Inspiration Breath Hold and Active Breathing Control
A study testing AlignRT system (VisionRT Ltd., London, UK) in people with Left-Sided Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Left-Sided Breast Cancer
- What is being tested?
- AlignRT system (VisionRT Ltd., London, UK)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 19 May 2018to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Left-Sided Breast Cancer
- Being tested
- AlignRT system (VisionRT Ltd., London, UK)
- Medical subject headings
- Unilateral Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Breathing Control | Other | 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. Receives: Device: AlignRT system (VisionRT Ltd., London, UK) |
| Deep Inspiration Breath Hold | Other | 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. Receives: Device: AlignRT system (VisionRT Ltd., London, UK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- 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.
Measured: 2 years
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.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start19 May 2018
- Primary completion31 Dec 2021
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left-Sided Breast CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Irene Karam, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459898
- Sponsor's protocol ID
- 268-2017
- Status last verified
- May 2022
- First submitted
- 2 Feb 2018
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03459898
- Acronym / sponsor ID
- 268-2017
- Conditions
- Left-Sided Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 19 May 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- Right sided breast cancer patients
- Treatment with partial breast irradiation
- Previous left breast/chest wall irradiation
- Locally advanced breast cancer
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Active Breathing Control, Deep Inspiration Breath Hold |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlignRT system (VisionRT Ltd., London, UK) in people with Left-Sided Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility of ABC or vDIBH set-up as measured by Align RT. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.