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Clinical Trials/NCT02379988
NCT02379988
Completed
N/A

Pilot Study For Prone Breath Hold Technique to Decrease Cardiac and Pulmonary Doses in Women Receiving Left Breast Radiotherapy

University of Arizona1 site in 1 country15 target enrollmentNovember 6, 2014
ConditionsBreast Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Arizona
Enrollment
15
Locations
1
Primary Endpoint
The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques.
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receive for patients being treated for left sided breast cancer.

Detailed Description

Subjects have a standard of care CT simulation, which includes an additional breath hold CT. Inspiratory gated breath-hold will be used. Two radiation plans will be generated: one for the CT scan performed free breathing, and one for the CT scan performed with inspiratory gated breath hold. The cardiac and lung doses will be determined. At the discretion of the treating physician, the plan with the lower cardiac and lung dose may be used to treat the patient.

Registry
clinicaltrials.gov
Start Date
November 6, 2014
End Date
July 3, 2016
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients of Dr. Gonzalez
  • ≥18 years of age
  • Node-negative left breast cancer
  • Invasive or DCIS breast cancer
  • Prior lumpectomy
  • Deemed appropriate for treatment in the prone position by the treating physician
  • Able to tolerate prone position and breath hold during CT simulation

Exclusion Criteria

  • \<18 years of age
  • Patients requiring treatment in supine position

Outcomes

Primary Outcomes

The Radiation Dose in Gy to the Heart and Lung Using Two Radiation Techniques.

Time Frame: Treatment Day 1 (both pFB and pDIBH scans were done on the same day)

The primary endpoints of this study were to evaluate the feasibility of the combination of prone positioning and RPM pDIPH for breast cancer radiation treatment. Each woman enrolled in the study had 2 radiation plans generated: one for the pFB scan and one for the pDIBH scan. The mean difference between the dosimetrically determined heart, left anterior descending (LAD) artery, and left lung radiation doses were computed with the associated 95% confidence interval; however, the Wilcoxin paired signed rank test was used and listed below as the primary analysis because of the non-normal distributions.

Secondary Outcomes

  • Heart Mean Dose Based on Breast Volume(Treatment Day 1)
  • Determination of Left Anterior Artery (LAD) Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added.(Treatment Day 1)
  • Determination of Cardiac Dose and Lung Dose Reduction in Women Receiving Prone Breast Radiotherapy When Inspiratory Gating is Added.(Treatment Day 1)

Study Sites (1)

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