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A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radiation Therapy (RT)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Radiation, Prone position, Supine position, DIBH, Invasive Breast Carcinoma, Ductal Breast Carcinoma In Situ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Any woman with biopsy proven left breast DCIS or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist

Exclusion Criteria:

  • Previous radiation to the ipsilateral breast
  • All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Radiation Therapy (RT)

    Arm Description

    Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription.

    Outcomes

    Primary Outcome Measures

    Mean cardiac dose
    Assess whether the mean cardiac dose in the supine DIBH plan differs from the mean cardiac dose in the prone plan within strata defined by total RT dose.

    Secondary Outcome Measures

    Volume of heart receiving > 20 gray (Gy)
    The volume of heart receiving >20Gy in DIBH plan vs. prone plan
    Mean left anterior descending artery (LAD) dose in DIBH plan vs. prone plan
    The mean LAD dose in DIBH plan vs. prone plan
    Maximum left anterior descending artery (LAD) dose in DIBH plan vs. prone plan
    The maximum LAD dose in DIBH plan vs. prone plan
    Mean ipsilateral lung dose
    The mean ipsilateral lung dose in DIBH plan vs. prone plan
    Volume of ipsilateral lung receiving > 20Gy
    The volume of ipsilateral lung receiving >20Gy in DIBH plan vs. prone plan
    Volume of the contralateral breast receiving > 5 Gy
    The volume of the contralateral breast receiving >5Gy in DIBH plan vs. prone plan
    Maximum point dose to planning target volume (PTV) breast
    The maximum point dose to PTV breast in DIBH plan vs. prone plan
    Maximum separation
    The maximum separation in DIBH plan vs. prone plan
    Distance from the mid-sternum to the nipple when the patient is in the prone position
    Distance from the mid-sternum to the nipple when the patient is in the prone position
    PTV breast volume as calculated on the prone scan
    PTV breast volume as calculated on the prone scan
    Change in distance between the chest wall and heart (at the most lateral portion of the chest-wall-heart interface)
    The change in distance between the chest wall and heart (at the most lateral portion of the chestwall-heart interface) between the free breathing scout films and the DIBH scout films
    Patient treatment plan (supine with DIBH or prone)
    Will be described by proportions and frequency distributions. Logistic regression will be used to assess how each of the covariates (primary and secondary endpoints) affects the probability of being selected to undergo RT using the supine DIBH plan. ROC curves will be generated for various cut-points of the true proportion of patients requiring the supine DIBH plan.

    Full Information

    First Posted
    February 5, 2018
    Last Updated
    February 16, 2023
    Sponsor
    NYU Langone Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03437161
    Brief Title
    A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation
    Official Title
    A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 17, 2017 (Actual)
    Primary Completion Date
    September 26, 2017 (Actual)
    Study Completion Date
    February 15, 2023 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. Prone breast radiation therapy is a technique in which a patient receives treatment "face-down" to minimize the radiation to the rest of the body, including the heart and lungs. Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.
    Detailed Description
    Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Radiation, Prone position, Supine position, DIBH, Invasive Breast Carcinoma, Ductal Breast Carcinoma In Situ

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Radiation Therapy (RT)
    Arm Type
    Experimental
    Arm Description
    Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription.
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiation Therapy (RT)
    Other Intervention Name(s)
    Cancer Radiotherapy, Radiotherapy, RT
    Intervention Description
    Undergo RT either in the supine position with DIBH or in the prone position.
    Primary Outcome Measure Information:
    Title
    Mean cardiac dose
    Description
    Assess whether the mean cardiac dose in the supine DIBH plan differs from the mean cardiac dose in the prone plan within strata defined by total RT dose.
    Time Frame
    Up to 6 weeks
    Secondary Outcome Measure Information:
    Title
    Volume of heart receiving > 20 gray (Gy)
    Description
    The volume of heart receiving >20Gy in DIBH plan vs. prone plan
    Time Frame
    Up to 6 weeks
    Title
    Mean left anterior descending artery (LAD) dose in DIBH plan vs. prone plan
    Description
    The mean LAD dose in DIBH plan vs. prone plan
    Time Frame
    Up to 6 weeks
    Title
    Maximum left anterior descending artery (LAD) dose in DIBH plan vs. prone plan
    Description
    The maximum LAD dose in DIBH plan vs. prone plan
    Time Frame
    Up to 6 weeks
    Title
    Mean ipsilateral lung dose
    Description
    The mean ipsilateral lung dose in DIBH plan vs. prone plan
    Time Frame
    Up to 6 weeks
    Title
    Volume of ipsilateral lung receiving > 20Gy
    Description
    The volume of ipsilateral lung receiving >20Gy in DIBH plan vs. prone plan
    Time Frame
    Up to 6 weeks
    Title
    Volume of the contralateral breast receiving > 5 Gy
    Description
    The volume of the contralateral breast receiving >5Gy in DIBH plan vs. prone plan
    Time Frame
    Up to 6 weeks
    Title
    Maximum point dose to planning target volume (PTV) breast
    Description
    The maximum point dose to PTV breast in DIBH plan vs. prone plan
    Time Frame
    Up to 6 weeks
    Title
    Maximum separation
    Description
    The maximum separation in DIBH plan vs. prone plan
    Time Frame
    Up to 6 weeks
    Title
    Distance from the mid-sternum to the nipple when the patient is in the prone position
    Description
    Distance from the mid-sternum to the nipple when the patient is in the prone position
    Time Frame
    Up to 6 weeks
    Title
    PTV breast volume as calculated on the prone scan
    Description
    PTV breast volume as calculated on the prone scan
    Time Frame
    Up to 6 weeks
    Title
    Change in distance between the chest wall and heart (at the most lateral portion of the chest-wall-heart interface)
    Description
    The change in distance between the chest wall and heart (at the most lateral portion of the chestwall-heart interface) between the free breathing scout films and the DIBH scout films
    Time Frame
    Up to 6 weeks
    Title
    Patient treatment plan (supine with DIBH or prone)
    Description
    Will be described by proportions and frequency distributions. Logistic regression will be used to assess how each of the covariates (primary and secondary endpoints) affects the probability of being selected to undergo RT using the supine DIBH plan. ROC curves will be generated for various cut-points of the true proportion of patients requiring the supine DIBH plan.
    Time Frame
    Up to 6 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Any woman with biopsy proven left breast DCIS or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist Exclusion Criteria: Previous radiation to the ipsilateral breast All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Naamit Gerber, MD
    Organizational Affiliation
    Laura and Isaac Perlmutter Cancer Center at NYU Langone
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation

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