Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/18/2016 |
| Start Date: | March 2015 |
| End Date: | December 2016 |
| Contact: | Denise Pitt, JD |
| Email: | denise.pitt@huntingtonhospital.com |
| Phone: | (626) 397-3764 |
A Phase II Study of the Outcomes of Intraoperative Margin Assessment With Adjunctive Use of MarginProbe in Addition to Standard
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.
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.
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.
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.
Inclusion Criteria:
1. Subjects able to read and understand the informed consent
Exclusion Criteria:
1. Subjects unable to read or understand the informed consent.
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