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
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
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
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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