Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe

NCT ID: NCT02456649

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-09-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

MarginProbe

Single arm study - MarginProbe in addition to standard procedure

Group Type: EXPERIMENTAL

MarginProbe

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Huntington Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeannie Shen

Medical director, Breast Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeannie Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Huntington Memorial Hospital

Locations

Huntington Memorial Hospital

Pasadena, California, United States

Countries

United States

References

Moran MS, Schnitt SJ, Giuliano AE, et al. JCO Feb 10, 2014.

Reference Type: BACKGROUND

Allweis TM, Kaufman Z, Lelcuk S, Pappo I, Karni T, Schneebaum S, Spector R, Schindel A, Hershko D, Zilberman M, Sayfan J, Berlin Y, Hadary A, Olsha O, Paran H, Gutman M, Carmon M. A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery. Am J Surg. 2008 Oct;196(4):483-9. doi: 10.1016/j.amjsurg.2008.06.024.

Reference Type: RESULT

PMID: 18809049 (View on PubMed)

Pappo I, Spector R, Schindel A, Morgenstern S, Sandbank J, Leider LT, Schneebaum S, Lelcuk S, Karni T. Diagnostic performance of a novel device for real-time margin assessment in lumpectomy specimens. J Surg Res. 2010 May 15;160(2):277-81. doi: 10.1016/j.jss.2009.02.025. Epub 2009 Mar 31.

Reference Type: RESULT

PMID: 19628225 (View on PubMed)

Rivera RJ, Holmes DR, Tafra L. Analysis of the Impact of Intraoperative Margin Assessment with Adjunctive Use of MarginProbe versus Standard of Care on Tissue Volume Removed. Int J Surg Oncol. 2012;2012:868623. doi: 10.1155/2012/868623. Epub 2012 Dec 26.

Reference Type: RESULT

PMID: 23326653 (View on PubMed)

Thill M, Dittmer C, Baumann K, Friedrichs K, Blohmer JU. MarginProbe(R)--final results of the German post-market study in breast conserving surgery of ductal carcinoma in situ. Breast. 2014 Feb;23(1):94-6. doi: 10.1016/j.breast.2013.11.002. Epub 2013 Dec 2.

Reference Type: RESULT

PMID: 24291375 (View on PubMed)

Schnabel F, Boolbol SK, Gittleman M, Karni T, Tafra L, Feldman S, Police A, Friedman NB, Karlan S, Holmes D, Willey SC, Carmon M, Fernandez K, Akbari S, Harness J, Guerra L, Frazier T, Lane K, Simmons RM, Estabrook A, Allweis T. A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. Ann Surg Oncol. 2014 May;21(5):1589-95. doi: 10.1245/s10434-014-3602-0. Epub 2014 Mar 5.

Reference Type: RESULT

PMID: 24595800 (View on PubMed)

Police AM. Routine use of a real time margin assessment device. Poster Abstract presented at the 31st Annual Miami Breast Cancer Conference; May 2014.

Reference Type: RESULT

Sebastian M, Akbari S. Combined experience at three breast centers with routine use of an intraoperative margin assessment device including comparison to historical re-excision rates. Poster Abstract presented at ASCO Breast Cancer Symposium; September 2014.

Reference Type: RESULT

Other Identifiers

HMH2015.001

Identifier Type: -

Identifier Source: org_study_id