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OpenTrials
Completed

NCT Number: NCT00181363

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht Radiation Oncology

Heerlen, Limburg, 6419 PC, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mamma board

Device

use of mamma board during radiotherapy

Other names: radiation, prone breast, mammaboard

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. PTV Coverage in Organs at Risk: MLD (Gy)

    Time frame: during treatment planning

    Doses in organs at risk: lung MLD (Mean Lung Dose)

  2. 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

Sponsors and collaborators

Lead sponsor

Maastricht Radiation Oncology

Other

Collaborators

  • Maastricht University

Registry information

Official study title

Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts

Important dates

Study start
2003
Primary completion
2006
Study completion
2007
First posted
Sep 16, 2005
Registry last updated
Jan 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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