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

NCT00578747 | Completed

• 1 other identifier: BC-RES07KWA
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Breast Neoplasms; Targeted Radiotherapy; Mastectomy; Seroma

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• may participate in this study if they satisfy all of the following criteria:
• You have a new diagnosis of in-situ or invasive breast cancer with no evidence of distant disease spread
• You have no evidence of disease spread to the axillary lymph glands
• You were treated by lumpectomy (partial mastectomy) with no cancer found microscopically at the edge of the removed breast tissue (called negative margins).
• 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.
• You fully understand the study and give your informed consent to participate as demonstrated by signing this consent form.

You may not qualify if:

• You cannot participate in this if any of the following applies to you:
• If your tumor was larger than 3 cm in diameter on pathological examination.
• You had more than one primary tumour in different quadrants of the same breast.
• You are currently pregnant or lactating.
• You are suffering from psychiatric or addictive disorders which would prevent you from giving informed consent or carrying out the requirements of the study.
• It is not possible to localize the surgical cavity on CT scan.
• You have a breast implant or pacemaker on the side being treated.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (2)

BC Cancer Agency-Fraser Valley Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

British Columbia Cancer Agency- Fraser Valley Centre

Surrey, British Columbia, V3V 1Z2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Seroma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Winkle A Kwan, MD

  BC Cancer Agency- Fraser Valley Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 21, 2007
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 4, 2015

Record last verified: 2015-09

Locations

CA (2)