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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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ClinicalTrials.gov Identifier: NCT03459898
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Irene Karam, Sunnybrook Health Sciences Centre

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).

Condition or disease Intervention/treatment Phase
Left-Sided Breast Cancer Device: AlignRT system (VisionRT Ltd., London, UK) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 19, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459898


Contacts
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Contact: Irene Karam, MD 416-480-4974 irene.karam@sunnybrook.ca
Contact: Matt Wronski, PhD 416-480-5000 ext 5853 matt.wronski@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Irene Karam    416-480-6100 ext 2749    Irene.Karam@sunnybrook.ca   
Contact: Matt Wronski, PhD    416-480-6100 ext 5853    Matt.Wronski@sunnybrook.ca   
Principal Investigator: Irene Karam, MD, FRCPC         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre

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Responsible Party: Dr. Irene Karam, Radiation Oncologist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03459898     History of Changes
Other Study ID Numbers: 268-2017
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Unilateral Breast Neoplasms
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases