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Prone Breast Irradiation for Pendulous Breasts

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Maastricht Radiation Oncology.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181363
First Posted: September 16, 2005
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Maastricht University Medical Center
Information provided by:
Maastricht Radiation Oncology
  Purpose
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 and normal tissues in prone position versus supine position.

Condition Intervention
Breast Cancer Device: Mamma board

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mamma Board Project: Prone Breast Irradiation for Pendulous Breasts

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • In 10 patients a conventional simulation will be done in supine and prone position. A planning CT-scan will be obtained in both positions. A lead wire will be placed around the palpable breast tissue as an aid in the delineation.

Secondary Outcome Measures:
  • Volume of the CTV (cc),Maximum dose delivered in at least 1 cc,Minimum dose in PTV, delivered in at least 1% of the PTV
  • PTV coverage (% of PTV < 95% of prescribed dose),Doses in organs at risk (heart: V30, V40, V50, lung: V20, MLD)

Estimated Enrollment: 10
Study Start Date: December 2003
Estimated Study Completion Date: January 2010
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients should have had breast-conserving surgery for breast cancer or DCIS
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181363


Locations
Netherlands
Maastricht Radiation Oncology
Heerlen, Limburg, Netherlands, 6419 PC
Sponsors and Collaborators
Maastricht Radiation Oncology
Maastricht University Medical Center
Investigators
Principal Investigator: Jeroen Buijsen, MD Maastricht Radiation Oncology
  More Information

ClinicalTrials.gov Identifier: NCT00181363     History of Changes
Other Study ID Numbers: P03.1446L
First Submitted: September 9, 2005
First Posted: September 16, 2005
Last Update Posted: October 12, 2017
Last Verified: April 2007

Keywords provided by Maastricht Radiation Oncology:
Breast cancer
Breast conserving surgery
Radiotherapy
Pendulous breasts