Do Skin Markings Reflect the Location of the Surgical Cavity During Daily Radiotherapy Treatment?
This study has been completed.
Sponsor:
British Columbia Cancer Agency
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
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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:
- 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.
Exclusion Criteria:
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.
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 June 18, 2013