Working… Menu

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

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: NCT00972010
Recruitment Status : Completed
First Posted : September 4, 2009
Last Update Posted : July 12, 2019
Medtronic Surgical Technologies
Information provided by (Responsible Party):
Sarah Blair, M.D., University of California, San Diego

Brief Summary:
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.

Condition or disease
Breast Cancer

Detailed Description:

Breast conservation therapy (BCT) is the standard surgical treatment for breast cancer. The goal of BCT is total excision of the malignant lesion while simultaneously preserving the cosmetic appearance and functionality of the breast. Despite advances in technique and pathologic analysis; however, 20-50% of malignant breast lump excisions have cancer present to the edge of the excision margin (defined as a "positive" margin). Excisions that are found to be margin positive require a secondary excision; however, in these cases residual disease is found to be present in only 40-70% of cases. Some researchers have hypothesized that re-excision was unnecessary in a certain percentage of cases. Currently there are no routinely utilized method for intra-operative interpretation of surgical margins. Touch preps or imprint cytology has been used in the past in some centers but it is not used routinely because an experienced cytopathologist is needed to correctly interpret the slides.

The standard of care to evaluate surgical margins is based on permanent section. Margins are considered negative if there is greater than 1 mm of normal tissue between cancer cells to the excised surface. Many factors for this discrepancy have been postulated, including artifact associated with the inking process and with electrosurgery induced damage of the margin during excision (thermal injury); therefore, creating a "false positive" impression of tumor cells present at surgical margins. We propose a clinical study to evaluate the effects of thermal injury in breast cancer excision using traditional electrosurgery (i.e., the "Bovie") compared to the pulsed RF technology with the PEAK PlasmaBlade. We hypothesize that the PlasmaBlade will impart less thermal injury to the incised breast tissue (malignant and normal) and will increase the specificity of the margin status. The majority of breast cancers are removed by traditional electrocautery. We are just starting to utilize this new technology for soft tissue dissection at UCSD.

The PEAK PlasmaBlade is a family of disposable surgical cutting and coagulation devices that offer the exacting control of a scalpel and the bleeding control of traditional electrosurgery without extensive collateral damage. The PlasmaBlade is based on proprietary pulsed plasma technology. This technology represents an evolutionary leap in the advancement of radiofrequency surgical technologies, which originated with traditional electrosurgery and progressed to plasma-mediated energy devices. The PlasmaBlade tissue dissection devices are FDA-cleared and commercially available.

Layout table for study information
Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Prospective, Controlled Study To Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade Compared to Traditional Electrosurgery
Study Start Date : July 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To compare the thermal injury artifact produced by traditional electrosurgery vs. the PEAK PlasmaBlade by intensive pathologic analysis both by gross inspection, touch imprint, and permanent histologic analysis. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Breast tissue

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.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients recruited from the Moores UCSD Cancer Center and the UCSD Medical Center

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

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): NCT00972010

Layout table for location information
United States, California
Thornton Hospital
La Jolla, California, United States, 92037
Rebecca and John Moores Cancer Center
La Jolla, California, United States, 92093
UCSD Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
Sarah Blair, M.D.
Medtronic Surgical Technologies
Layout table for investigator information
Principal Investigator: Sarah L Blair, MD University of California, San Diego
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sarah Blair, M.D., Professor of Surgery, University of California, San Diego Identifier: NCT00972010    
Other Study ID Numbers: 090314
First Posted: September 4, 2009    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Keywords provided by Sarah Blair, M.D., University of California, San Diego:
Breast conservation therapy