Prone Whole-Breast RadiationTherapy Versus Supine Whole-Breast Radiation Therapy Imaging

April 11, 2023 updated by: Anna Shapiro, State University of New York - Upstate Medical University

Prospective Trial of Prone Whole-Breast RadiationTherapy Versus Supine Whole-Breast Radiation Therapy With and Without Respiratory Gating, a Dosimetric Comparison

Radiation therapy to the breast has remained a standard practice for breast conserving therapy. Because of the location of the heart and lungs when patients are positioned face-up, whole breast radiation therapy has been reported to increase the risk of damage to the heart a few years after treatment until at least 20 years after exposure, and may affect cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an increased risk for development of secondary lung malignancies. Recent studies have demonstrated a significant reduction in dose to the heart and lungs when treated in the face-down position. Similarly, correcting for the movement of breathing (respiratory gating) in the face-up position has also become an available option for reducing unwanted dose to the heart and lungs, particularly in left sided breast cancers. No study to date has compared these newer organ-sparing techniques head-to-head for early stage breast cancer.

It is institutional policy to perform CT simulation in left-sided breast cancer patients with and without the respiratory gating (this is one CT scan), in the face-up position. It is also standard of care to perform the face-down CT simulation in large breasted women. Both of these simulations are meant to reduce the exposure of the heart and lungs to radiation.

In this study, all left-sided breast cancer patients that consent will receive face-up CT simulation with and without gating AND face-down CT simulation, regardless of breast size; thus, each patient is their own control.

The treating physician will determine which of the two simulations, if any, offers better protection to each patients' heart and lungs. Two dosimetrists will be required to independently verify planned dosimetry with all treatment setups. Treatment will be planned in standard fashion using the best of the two plans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Radiation therapy to the breast has remained a standard practice for breast conserving therapy. Because of the location of the heart and lungs when patients are positioned face-up, whole breast radiation therapy has been reported to increase the risk of damage to the heart a few years after treatment until at least 20 years after exposure, and may affect cardiovascular mortality. Also, patients receiving whole breast radiation therapy are at an increased risk for development of secondary lung malignancies. Recent studies have demonstrated a significant reduction in dose to the heart and lungs when treated in the face-down position. Similarly, correcting for the movement of breathing (respiratory gating) in the face-up position has also become an available option for reducing unwanted dose to the heart and lungs, particularly in left sided breast cancers. No study to date has compared these newer organ-sparing techniques head-to-head for early stage breast cancer.

It is institutional policy to perform CT simulation in left-sided breast cancer patients with and without the respiratory gating (this is one CT scan), in the face-up position. It is also standard of care to perform the face-down CT simulation in large breasted women. Both of these simulations are meant to reduce the exposure of the heart and lungs to radiation. In this study, all left-sided breast cancer patients that consent will receive face-up CT simulation with and without gating AND face-down CT simulation, regardless of breast size; thus, each patient is their own control.

The treating physician will determine which of the two simulations, if any, offers better protection to each patients' heart and lungs. Two dosimetrists will be required to independently verify planned dosimetry with all treatment setups. Treatment will be planned in standard fashion using the best of the two plans.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stage 0-IIA left, breast cancer,
  • After lumpectomy or segmental mastectomy,
  • With negative surgical margins

Exclusion Criteria:

  • Right breast cancer
  • Positive surgical margins
  • Stage 2B or higher

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Prone/Supine Simulation
It is institutional policy to perform CT simulation in left-sided breast cancer patients with and without the respiratory gating (this is one CT scan), in the face-up position. It is also standard of care to perform the face-down CT simulation in large breasted women. Both of these simulations are meant to reduce the exposure of the heart and lungs to radiation. In this study, all left-sided breast cancer patients that consent will receive face-up CT simulation with and without gating AND face-down CT simulation, regardless of breast size; thus, each patient is their own control.
Other: CT simulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean heart dose
Time Frame: immediate
dosimetric parameter
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

January 27, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (Estimate)

January 31, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 496516

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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