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

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. Identifier: NCT00578747
Recruitment Status : Completed
First Posted : December 21, 2007
Last Update Posted : September 4, 2015
Information provided by (Responsible Party):
Winkle Kwan, British Columbia Cancer Agency

Brief Summary:
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 or disease
Breast Cancer

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 21 participants
Time Perspective: Prospective
Official Title: Development of Improved Target Volume Localization for Accelerated Partial Breast Irradiation- Stage I
Study Start Date : January 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes 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)

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.

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 identifier (NCT number): NCT00578747

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
Principal Investigator: Winkle A Kwan, MD BC Cancer Agency- Fraser Valley Centre

Responsible Party: Winkle Kwan, Radiation Oncologist, British Columbia Cancer Agency Identifier: NCT00578747     History of Changes
Other Study ID Numbers: BC-RES07KWA
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015

Keywords provided by Winkle Kwan, British Columbia Cancer Agency:
Breast Cancer
Breast Neoplasms
Targeted Radiotherapy