Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: MarginProbe

• Registration Number: NCT02456649
• Lead Sponsor: Huntington Memorial Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-28
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-30
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

1. Subjects able to read and understand the informed consent

Exclusion Criteria

1. Subjects unable to read or understand the informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MarginProbe	MarginProbe	Single arm study - MarginProbe in addition to standard procedure

Primary Outcome Measures

Name	Time	Method
Percentage of patients with histologically positive surgical margins	2 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
Percentage of patients who undergo a second surgery after initial lumpectomy.	2 weeks after surgery
False positive and false negative rate of Intraop MarginProbe results compared to histologic evaluation	2 weeks after surgery

Trial Locations

Locations (1)

Huntington Memorial Hospital; 🇺🇸 Pasadena, California, United States