Breast CancerNCT00972010
Study to Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade
An observational study of Breast Cancer, run by Sarah Blair, M.D. at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 21 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients recruited from the Moores UCSD Cancer Center and the UCSD Medical Center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Thornton Hospital
La Jolla, California, 92037
Rebecca and John Moores Cancer Center
La Jolla, California, 92093
UCSD Medical Center
San Diego, California, 92103
About this study
Official title: A Prospective, Controlled Study To Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade Compared to Traditional Electrosurgery
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Breast, Cancer, Lumpectomies, PlasmaBlade, Breast conservation therapy
- Medical subject headings
- Breast Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Blair, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Surgical Technologies
- Responsible party
- Sponsor-investigator, Sarah Blair, M.D., University of California, San Diego
- Investigators
- Sarah L Blair, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972010
- Sponsor's protocol ID
- 090314
- Status last verified
- Jul 2019
- First submitted
- 3 Sep 2009
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruidiaz ME, Cortes-Mateos MJ, Sandoval S, Martin DT, Wang-Rodriguez J, Hasteh F, Wallace A, Vose JG, Kummel AC, Blair SL. Quantitative comparison of surgical margin histology following excision with traditional electrosurgery and a low-thermal-injury dissection device. J Surg Oncol. 2011 Dec;104(7):746-54. doi: 10.1002/jso.22012. Epub 2011 Jul 8.
PubMed 21744349
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Controlled Study To Evaluate Surgical Excision Margins in Malignant Breast Lumpectomies With the PEAK PlasmaBlade Compared to Traditional Electrosurgery
- ClinicalTrials.gov ID
- NCT00972010
- Acronym / sponsor ID
- 090314
- Conditions
- Breast Cancer
- Keywords
- Breast, Cancer, Lumpectomies, PlasmaBlade, Breast conservation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sarah Blair, M.D.University, hospital or other
- Collaborators
- Medtronic Surgical Technologies
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients recruited from the Moores UCSD Cancer Center and the UCSD Medical Center
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Derived from this study: PubMed 21744349Ruidiaz ME, Cortes-Mateos MJ, Sandoval S, Martin DT, Wang-Rodriguez J, Hasteh F, Wallace A, Vose JG, Kummel AC, Blair SL. Quantitative comparison of surgical margin histology following excision with traditional electrosurgery and a low-thermal-injury dissection device. J Surg Oncol. 2011 Dec;104(7):746-54. doi: 10.1002/jso.22012. Epub 2011 Jul 8.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah L Blair, MD principal investigator
University of California, San Diego
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sarah Blair, M.D. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00972010, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2019.