MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery

NCT00749931 | Completed Results

• 1 other identifier: CP-03-001
• Study Type: interventional
• Target: 664
• Locations: 2 countries
• Sites: 21

Brief Summary

The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.

Conditions

Breast Cancer

Keywords

IDC, DCIS, ILC

Outcome Measures

Primary Outcomes (1)

• The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity.

  Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively

  two weeks after surgery

Study Arms (2)

SOC

ACTIVE COMPARATOR

Standard of Care arm - standard of care lumpectomy procedure

Procedure: Lumpectomy

Device + SOC

EXPERIMENTAL

Use of the device in addition to the standard of care lumpectomy procedure.

Device: MarginProbe; Procedure: Lumpectomy

Interventions

MarginProbe DEVICE

Device use to assess margin status of the excised specimen surface.

Device + SOC

Lumpectomy PROCEDURE

Standard of care lumpectomy procedure

Device + SOC; SOC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women histologically diagnosed with carcinoma of the breast
• Women with non-palpable malignant lesions, requiring image guided localization.
• Undergoing lumpectomy (partial mastectomy) procedure.
• Age 18 years or more
• Signed ICF

You may not qualify if:

• Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
• Bilateral disease (diagnosed cancer in both breasts)
• Neoadjuvant systemic therapy
• Previous radiation in the operated breast
• Prior surgical procedure in the same breast
• Implants in the operated breast
• Pregnancy
• Lactation
• Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Sponsors & Collaborators

• Dune Medical Devices: lead

Study Sites (21)

Pacific Breast Care

Costa Mesa, California, 92627, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars Sinai Hospital

Los Angeles, California, 90048, United States

Location

HOAG Memorial Hospital

Newport Beach, California, 92658-6100, United States

Location

St. Joseph Hospital

Orange, California, 92868, United States

Location

UCIrvine Medical Center

Orange, California, 92868, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Mercy Hospital Services

Baltimore, Maryland, 21202, United States

Location

Franklin Square Hospital Center

Baltimore, Maryland, 21237, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

NYU Clinical Cancer Center

New York, New York, 10016, United States

Location

St. Luke's Roosevelt

New York, New York, 10019, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Breast Care Center

Allentown, Pennsylvania, 18104, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States

Location

Virginia Hospital Center

Arlington, Virginia, 22205, United States

Location

Haddasah Medical Organization

Jerusalem, Israel

Location

Shaare Zedek

Jerusalem, Israel

Location

Assaf Harofeh Medical Center

Zrifin, 70300, Israel

Location

Related Publications (1)

• 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

Related Links

• Dune Medical Devices official web site

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Results Point of Contact

• Title: Clinical Research Manager
• Organization: Dune Medical Devices

shiri@dunemedical.com

+97246178000

Study Officials

• Tanir M. Allweis, MD

  Hadassah Medical Organization, Israel

  PRINCIPAL INVESTIGATOR

• Moshe Carmon, MD

  Shaare Zedek Medical Center, Israel

  PRINCIPAL INVESTIGATOR

• Tami Karni, MD

  Assaf Harefeh Medical Center, Israel

  PRINCIPAL INVESTIGATOR

• Alison Estabrook, MD

  St. Luke's Roosevelt, NY, USA

  PRINCIPAL INVESTIGATOR

• Freya Schnabel, MD

  NYU Clinical Cancer Center, NY, USA

  PRINCIPAL INVESTIGATOR

• Rache M. Simmons, MD

  Weill Medical College of Cornell University, NY, USA

  PRINCIPAL INVESTIGATOR

• Sheldon M. Feldman, MD

  Columbia University Medical Center, NY, USA

  PRINCIPAL INVESTIGATOR

• Mark A. Gittelman, MD

  Breast Care Specialist, Allentown, Pennsylvania, USA

  PRINCIPAL INVESTIGATOR

• Neil Friedman, MD

  Mercy Health Srvices, Baltimore, USA

  PRINCIPAL INVESTIGATOR

• Kristen L. Fernandez, MD

  Franklin Square Hospital Center, Baltimore, USA

  PRINCIPAL INVESTIGATOR

• Shawna C. Willey, MD

  Georgetown University Hospital, Washington, USA

  PRINCIPAL INVESTIGATOR

• Lorraine Tafra, MD

  Anne Arundel Medical Center, Annapolis, USA

  PRINCIPAL INVESTIGATOR

• Karen Lane, MD

  UCIrvine Medical Center, California, USA

  PRINCIPAL INVESTIGATOR

• Jay Harness, MD

  St. Joseph Hospital, California, USA

  PRINCIPAL INVESTIGATOR

• Alice Police, MD

  Pacific Breast Care, California, USA

  PRINCIPAL INVESTIGATOR

• Dennis R. Holmes, MD

  University of South California, California, USA

  PRINCIPAL INVESTIGATOR

• Scott Karlan, MD

  Cedars Sinai Hospital, California, USA

  PRINCIPAL INVESTIGATOR

• Stephanie Akbari, MD

  Virginia Hospital Center

  PRINCIPAL INVESTIGATOR

• Thomas Frazier, MD

  Bryn Mawr Hospital

  PRINCIPAL INVESTIGATOR

• Lisa E. Guerra, MD

  HOAG Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Susan K. Boolbol, MD

  Beth Israel Medical Center, NY, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2008
• First Posted: September 9, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 27, 2014
• Results First Posted: June 27, 2014

Record last verified: 2014-05

Locations

US (18); IL (3)