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


N/A
18 Years
90 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome 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.

Outcome Time Frame:

two weeks after surgery

Safety Issue:

No

Principal Investigator

Tanir M. Allweis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization, Israel

Authority:

United States: Food and Drug Administration

Study ID:

CP-03-001

NCT ID:

NCT00749931

Start Date:

October 2008

Completion Date:

June 2010

Related Keywords:

  • Breast Cancer
  • IDC, DCIS, ILC
  • Breast Neoplasms

Name

Location
Beth Israel Medical Center New York, New York  10003
Franklin Square Hospital Center Baltimore, Maryland  21237
Weill Medical College of Cornell University New York, New York  10021
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Anne Arundel Medical Center Annapolis, Maryland  21401
Georgetown University Hospital Washington, District of Columbia  20007
University of Southern California Los Angeles, California  90033
Columbia University Medical Center New York, New York  10032
NYU Clinical Cancer Center New York, New York  10016
St. Joseph Hospital Orange, California  92868
Virginia Hospital Center Arlington, Virginia  22205
Pacific Breast Care Costa Mesa, California  92627
Cedars Sinai Hospital Los Angeles, California  90048
HOAG Memorial Hospital Newport Beach, California  92658-6100
UCIrvine Medical Center Orange, California  92868
Mercy Hospital Services Baltimore, Maryland  21202
St. Luke's Roosevelt New York, New York  10019
Breast Care Center Allentown, Pennsylvania  18104