Expired Study
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Pasadena, California 91105


Purpose:

The combination of breast conserving surgery (lumpectomy) with radiation therapy has been shown to result in equivalent overall survival rates compared to mastectomy for the local treatment of breast cancer. As a result, the majority of patients diagnosed with breast cancer in the United States undergo lumpectomy as their primary surgical therapy. Multiple studies have demonstrated the association between positive lumpectomy margins and an increased risk of ipsilateral breast tumor recurrence, even with postoperative radiation. Studies report 20-40% of lumpectomy procedures result in one or more involved (positive) surgical margins, leading to the need for further surgery, emotional distress, poorer cosmesis, delay to adjuvant treatments, and increased cost. Current available intraoperative margin assessment techniques include specimen Xray, gross pathology, frozen section, and touch prep cytology. To reduce the incidence of positive margins, the MarginProbe (Dune Medical Devices, Caesarea, Israel) was developed to provide real-time, intraoperative assessment of the presence of tumor at the lumpectomy margin. In the current study, the investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to standard practice for intraoperative identification of tumor at lumpectomy margins, and its ability to reduce positive margins and decrease the need for additional surgical procedures.


Study summary:

In the current study, the investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to standard practice for intraoperative identification of tumor at lumpectomy margins, and its ability to reduce positive margins and decrease the need for additional surgical procedures. Aims of the study: Primary objectives 1. Determine positive margin rate following lumpectomy Secondary objectives 1. Determine accuracy of intraoperative margin assessment with use of MarginProbe plus standard of care (gross pathologic examination and/or intraoperative specimen Xray) versus standard of care (gross pathologic examination and/or intraoperative specimen Xray) alone. 2. Determine impact of MarginProbe on total tissue volume removed 3. Determine the impact of MarginProbe on the need for additional surgical procedures.


Criteria:

Inclusion Criteria: 1. Subjects able to read and understand the informed consent Exclusion Criteria: 1. Subjects unable to read or understand the informed consent.


NCT ID:

NCT02456649


Primary Contact:

Principal Investigator
Jeannie Shen, MD
Huntington Memorial Hospital


Backup Contact:

N/A


Location Contact:

Pasadena, California 91105
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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