Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe

Breast Cancer Clinical Trial

— MarginProbe  

Official title:

A Phase II Study of the Outcomes of Intraoperative Margin Assessment With Adjunctive Use of MarginProbe in Addition to Standard

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456649
• Other study ID #: HMH2015.001
• Status: Completed
• Phase: N/A
• First received: May 19, 2015
• Last updated: September 30, 2016
• Start date: March 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Huntington Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Huntington Memorial Hospital	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Huntington Memorial Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

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, in — View Citation

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

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. — View Citation

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

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. — View Citation

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 s — View Citation

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 20

Thill M, Dittmer C, Baumann K, Friedrichs K, Blohmer JU. MarginProbe®--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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with histologically positive surgical margins		2 weeks after surgery	No
Secondary	Percentage of patients who undergo a second surgery after initial lumpectomy.		2 weeks after surgery	No
Secondary	False positive and false negative rate of Intraop MarginProbe results compared to histologic evaluation		2 weeks after surgery	No