Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe

NCT02456649 | Completed

• 1 other identifier: HMH2015.001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

lumpectomy margins

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with histologically positive surgical margins

  2 weeks after surgery

Secondary Outcomes (2)

• 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

Study Arms (1)

MarginProbe

EXPERIMENTAL

Single arm study - MarginProbe in addition to standard procedure

Device: MarginProbe

Interventions

MarginProbe 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.

MarginProbe

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects able to read and understand the informed consent

You may not qualify if:

• \. Subjects unable to read or understand the informed consent.

Sponsors & Collaborators

• Huntington Memorial Hospital: lead

Study Sites (1)

Huntington Memorial Hospital

Pasadena, California, 91105, United States

Location

Related Publications (8)

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

  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.

  PMID: 18809049 RESULT

• 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.

  PMID: 19628225 RESULT

• 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.

  PMID: 23326653 RESULT

• 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.

  PMID: 24291375 RESULT

• 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.

  PMID: 24595800 RESULT

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

  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.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeannie Shen, MD

  Huntington Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical director, Breast Surgery

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 28, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)