Do Skin Markings Reflect the Location of the Surgical Cavity During Daily Radiotherapy Treatment?

This study has been completed.
Sponsor:
Information provided by:
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00578747
First received: December 19, 2007
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

Markings placed on the skin are an accurate representation of the underlying surgical cavity and are adequate to use for patient setup for accelerated partial breast irradiation.


Condition
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Development of Improved Target Volume Localization for Accelerated Partial Breast Irradiation- Stage I

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Estimated Enrollment: 20
Study Start Date: January 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women in the Fraser Valley, with Breast cancer that is suitable for treatment with a new radiation treatment procedure called accelerated partial breast irradiation (APBI)

Criteria

Inclusion Criteria:

  • may participate in this study if they satisfy all of the following criteria:

    1. You have a new diagnosis of in-situ or invasive breast cancer with no evidence of distant disease spread
    2. You have no evidence of disease spread to the axillary lymph glands
    3. You were treated by lumpectomy (partial mastectomy) with no cancer found microscopically at the edge of the removed breast tissue (called negative margins).
    4. Your surgical cavity can be treated with APBI. This is dependent on many physical factors such as the size, shape, and location of the surgical cavity; the size and shape of the entire breast; as well as the exact location of the underlying heart and lungs.
    5. You fully understand the study and give your informed consent to participate as demonstrated by signing this consent form.

Exclusion Criteria:

  • You cannot participate in this if any of the following applies to you:

    1. If your tumor was larger than 3 cm in diameter on pathological examination.
    2. You had more than one primary tumour in different quadrants of the same breast.
    3. You are currently pregnant or lactating.
    4. You are suffering from psychiatric or addictive disorders which would prevent you from giving informed consent or carrying out the requirements of the study.
    5. It is not possible to localize the surgical cavity on CT scan.
    6. You have a breast implant or pacemaker on the side being treated.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578747

Locations
Canada, British Columbia
BC Cancer Agency-Fraser Valley Centre
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency- Fraser Valley Centre
Surrey, British Columbia, Canada, V3V 1Z2
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Winkle A Kwan, MD BC Cancer Agency- Fraser Valley Centre
  More Information

No publications provided

Responsible Party: Dr. Winkle Kwan, British Columbia Cancer Agency- Fraser Valley Centre
ClinicalTrials.gov Identifier: NCT00578747     History of Changes
Other Study ID Numbers: BC-RES07KWA
Study First Received: December 19, 2007
Last Updated: June 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:
Breast Cancer
Breast Neoplasms
Targeted Radiotherapy
Mastectomy
Seroma

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014