Prone Breast Irradiation for Pendulous Breasts

January 15, 2020 updated by: Maastricht Radiation Oncology

Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts

We hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the PTV, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart.The purpose of this study is to compare the 3-D dose distribution in PTV(Planning Target Volume) and normal tissues in prone position versus supine position.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Local excision followed by adjuvant radiotherapy has become standard treatment for women with early-stage breast cancer. Adjuvant radiotherapy may encounter technical difficulties in patients with pendulous breasts when treated in supine position.

Based upon literature and our own preliminary experiences, we hypothesize that for large pendulous breasts, breast irradiation in supine and prone position are equivalent with regard to coverage of the PTV, but with a better dose homogeneity in prone position and a smaller radiation exposure of lung and heart. However, no quantitative data are yet available to test this hypothesis. Therefore, the aim of our study is to compare the 3-D dose distribution in PTV and normal tissues in prone position versus supine position. For treatment in prone-position an in-house developed device, the "mammaboard" was used.

Study Type

Interventional

Enrollment (Actual)

10

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

  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419 PC
        • Maastricht Radiation Oncology

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

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients should have had breast-conserving surgery for breast cancer or DCIS (Ductal Carcinoma in Situ)
  • No indication for radiotherapy of regional nodes
  • Large, pendulous breasts (bra size D and over)

Exclusion Criteria:

  • Regional radiotherapy is indicated
  • Unable to lie in prone position

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mamma board
use of the mamma board during radiotherapy
Device: Mamma board
use of mamma board during radiotherapy
Other Names:
  • radiation, prone breast, mammaboard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Homogeneity 1: PTV
Time Frame: 1 day after treatment planning
Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) and normal tissues in prone position versus supine position
1 day after treatment planning
Dose Homogeneity 2: V105% and V107%
Time Frame: 1 day after treatment planning
Quantitatively compare the 3 D dose distribution in the PTV (Planning Target Volume) in prone position versus supine position
1 day after treatment planning
Dose Homogeneity 3: V95 %
Time Frame: 1 day after treatment planning
PTV coverage (% of PTV < 95% of prescribed dose) in prone position versus supine position
1 day after treatment planning

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTV Coverage in Organs at Risk: MLD (Gy)
Time Frame: during treatment planning
Doses in organs at risk: lung MLD (Mean Lung Dose)
during treatment planning
PTV Coverage in Organs at Risk: Heart V30
Time Frame: during treatment planning
Doses in organs at risk: heart V30: the volumes (%) of the heart that received >= 30Gy
during treatment planning

Collaborators and Investigators

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

Sponsor

Maastricht Radiation Oncology

Collaborators

Maastricht University

Investigators

  • Principal Investigator: Jeroen Buijsen, MD, Maastricht Radiation Oncology

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

December 1, 2003

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P03.1446L

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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