Clinical trial NCT02406599: MarginProbe® System U.S. Post-Approval Study
Official title: MarginProbe® System U.S. Post-Approval Study Protocol CP-07-001
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Dune Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 440
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Diagnostic accuracy at the margin level
timeFrame: Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
measure: Incomplete Surgical Resection (ISR )
timeFrame: Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
Secondary outcomes:
measure: Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery
timeFrame: Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
measure: Cosmesis evaluation
timeFrame: participants will be followed until 6 months ± 1 month after last surgical treatment visit, an avarage of of 8 months following initial lumpectomy
measure: Repeat lumpectomy rate
timeFrame: Participants will be followed for 2-5 weeks (average)
measure: Repeat lumpectomy and mastectomy rate
timeFrame: Participants will be followed for 2-5 weeks (average)
measure: Diagnostic Accuracy at the Patient Level (ignoring location)
timeFrame: Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
Other outcomes:
Locations:
city: Washington
country: United States
facility: Sibley Memorial Hospital
state: District of Columbia
city: Jacksonville
country: United States
facility: Baptist MD Anderson Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins Medicine
state: Maryland
city: Bethesda
country: United States
facility: Suburban Hospital
state: Maryland
city: Berkeley Heights
country: United States
facility: Summit Medical Group
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico University Cancer center
state: New Mexico
city: New York
country: United States
facility: Montefiore Medical Center
state: New York
city: Harrisburg
country: United States
facility: PinnacleHealth Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Dilon Medical Technologies Ltd.
name: Maya Livnat
role: STUDY_DIRECTOR
References: