Clinical trial NCT02456649: Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe
Official title: A Phase II Study of the Outcomes of Intraoperative Margin Assessment With Adjunctive Use of MarginProbe in Addition to Standard
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: lumpectomy margins
Lead sponsor: Huntington Memorial Hospital
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 64
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Percentage of patients with histologically positive surgical margins
timeFrame: 2 weeks after surgery
Secondary outcomes:
measure: Percentage of patients who undergo a second surgery after initial lumpectomy.
timeFrame: 2 weeks after surgery
measure: False positive and false negative rate of Intraop MarginProbe results compared to histologic evaluation
timeFrame: 2 weeks after surgery
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
Study officials:
affiliation: Huntington Memorial Hospital
name: Jeannie Shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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 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.
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.
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 2014.