Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe (MarginProbe)

September 30, 2016 updated by: Jeannie Shen, Huntington Memorial Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91105
        • Huntington Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MarginProbe
Single arm study - MarginProbe in addition to standard procedure
Device: MarginProbe
Intraoperative MarginProbe use as adjunct to standard practice MarginProbe will be used on the lumpectomy specimen within 20 minutes of excision, prior to specimen Xray or gross pathology evaluation. This may take up to 5 minutes. MarginProbe will indicate a positive or negative reading for each of the 6 circumferential margins, and the results will be recorded. Any margins determined by to < 5-10 mm by specimen Xray or gross pathology examination will be re-excised. In addition, any additional margins not already identified as < 5-10 mm, but identified as positive by MarginProbe will be re-excised where feasible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with histologically positive surgical margins
Time Frame: 2 weeks after surgery
2 weeks after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huntington Memorial Hospital

Investigators

  • Principal Investigator: Jeannie Shen, MD, Huntington Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

September 30, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HMH2015.001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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