MarginProbe® System U.S. Post-Approval Study



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:June 2015
End Date:March 31, 2020
Contact:Robin Fatzinger
Email:robin.fatzinger@dunemedical.com
Phone:6109843569

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MarginProbe® System U.S. Post-Approval Study Protocol CP-07-001

The study objective is to determine the MarginProbe® System's diagnostic accuracy at the
margin level and impact on Positive Margin* Presence originating from the Main ex-vivo
lumpectomy specimen after the initial lumpectomy surgery.

*A positive margin is defined in this study as a margin microscopically measured and reported
in the histology report to have cancer within 1 mm or less of the inked surface

This is a prospective, multicenter, randomized (1:1), double arm, controlled study, in which
subjects undergoing breast excision (lumpectomy) for carcinoma of the breast will be
randomized to either standard of care with additional inspection ('SOC + Additional
inspection' arm) or standard of care with MarginProbe as an adjunct ('SOC + Device' arm).

The MarginProbe is an adjunctive diagnostic tool for identification of cancerous tissue at
the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision. It
will be used by the surgeon during lumpectomy procedures only in patients randomized to the
"Device+SOC" arm.

Randomization will take place following the excision of the main ex-vivo lumpectomy specimen.

Inclusion Criteria:

- 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

Exclusion Criteria:

- Multi-centric disease (histologically diagnosed cancer in two different quadrants of
the breast)

- Bilateral disease (diagnosed cancer in both breasts)

- Neo-adjuvant systemic therapy

- Previous radiation in the operated breast

- Prior surgery in the same site in the breast

- Woman histologically diagnosed by an open biopsy procedure

- Implants in the operated breast

- Pregnancy

- Lactation

- Participating in any other investigational study for either drug or device which could
influence collection of valid data under this study

- Patients for whom complete cavity shaving is planned (sites where this is the routine
practice of the investigator will also be excluded from participation in the study)
We found this trial at
9
sites
Harrisburg, Pennsylvania 17109
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1201 Camino de Salud
Albuquerque, New Mexico 87102
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Albuquerque, NM
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733 North Broadway
Baltimore, Maryland 21205
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Baltimore, MD
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Berkeley Heights, New Jersey 07922
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Berkeley Heights, NJ
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Chicago, Illinois 60201
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Chicago, IL
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Jacksonville, Florida 32207
Principal Investigator: Beth-Ann Lesnikoski, MD
Phone: 904-202-7712
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Jacksonville, FL
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New York, New York 10467
Principal Investigator: Sheldon Feldman, MD
Phone: 718-920-6742
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New York, NY
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Tampa, Florida 33612
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Tampa, FL
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