MarginProbe, a Device for Intraoperative Assessment of Margin Status in Breast Conservation Surgery
18 Years
90 Years
Female
Breast Cancer
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 |
