Study to Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade

Completed

Conditions studied: Breast Cancer

In brief

The purpose of this research study is to find out more about distinguishing between cancerous and non-cancerous breast cancer cells at the edges of tumors. Using an FDA approved device to remove tumors, this device will be tested to see if it causes less tissue damage and therefore makes it easier to examine the tumor and make sure it is all excised. The tumors will be excised by standard surgical technique, and then the effects of the device on the removed tissues will be studied.

Key facts

Study ID

NCT00972010

Run by

Sarah Blair, M.D.

People needed

21

Starts

2009-07-01

Expected to finish

2010-11-01

Last updated by the study team

2019-07-12

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women or men with an established diagnosis of an invasive ductal carcinoma
• Women or men with tumors > 1cm
• Women undergoing Breast Conservation Operations
• Women or men may have had prior chemotherapy as long as their treatment was completed >2 weeks prior to enrollment with recovery from any toxicities

You may not qualify if…

• No established diagnosis of breast cancer
• Women or men with tumors <1 cm
• Women or men undergoing total mastectomy
• Women or men who have had prior radiation

Where it is running

• Thornton Hospital — La Jolla, California, United States
• Rebecca and John Moores Cancer Center — La Jolla, California, United States
• UCSD Medical Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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