Clinical trial NCT00749931: MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
Official title: MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: IDC, DCIS, ILC
Lead sponsor: Dune Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 664
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: two weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Pacific Breast Care
state: California
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Hospital
state: California
city: Newport Beach
country: United States
facility: HOAG Memorial Hospital
state: California
city: Orange
country: United States
facility: St. Joseph Hospital
state: California
city: Orange
country: United States
facility: UCIrvine Medical Center
state: California
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Mercy Hospital Services
state: Maryland
city: Baltimore
country: United States
facility: Franklin Square Hospital Center
state: Maryland
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: NYU Clinical Cancer Center
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: New-York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Allentown
country: United States
facility: Breast Care Center
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Arlington
country: United States
facility: Virginia Hospital Center
state: Virginia
city: Jerusalem
country: Israel
facility: Haddasah Medical Organization
city: Jerusalem
country: Israel
facility: Shaare Zedek
city: Zrifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Hadassah Medical Organization, Israel
name: Tanir M. Allweis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shaare Zedek Medical Center, Israel
name: Moshe Carmon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf Harefeh Medical Center, Israel
name: Tami Karni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Roosevelt, NY, USA
name: Alison Estabrook, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Clinical Cancer Center, NY, USA
name: Freya Schnabel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University, NY, USA
name: Rache M. Simmons, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University Medical Center, NY, USA
name: Sheldon M. Feldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Breast Care Specialist, Allentown, Pennsylvania, USA
name: Mark A. Gittelman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Health Srvices, Baltimore, USA
name: Neil Friedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Franklin Square Hospital Center, Baltimore, USA
name: Kristen L. Fernandez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgetown University Hospital, Washington, USA
name: Shawna C. Willey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anne Arundel Medical Center, Annapolis, USA
name: Lorraine Tafra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCIrvine Medical Center, California, USA
name: Karen Lane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph Hospital, California, USA
name: Jay Harness, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pacific Breast Care, California, USA
name: Alice Police, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South California, California, USA
name: Dennis R. Holmes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars Sinai Hospital, California, USA
name: Scott Karlan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Hospital Center
name: Stephanie Akbari, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bryn Mawr Hospital
name: Thomas Frazier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOAG Memorial Hospital
name: Lisa E. Guerra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Medical Center, NY, USA
name: Susan K. Boolbol, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.