MarginProbe® System U.S. Post-Approval Study
1 other identifier
interventional
440
1 country
11
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jun 2015
Longer than P75 for not_applicable breast-cancer
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 2, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedAugust 18, 2021
July 1, 2021
6.3 years
March 24, 2015
August 17, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Diagnostic accuracy at the margin level
Sensitivity and Specificity at the margin level;
Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
Incomplete Surgical Resection (ISR )
ISR - Positive Margin on the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery, that was not addressed by taking a shaving(s) corresponding to the positive margin(s).
Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
Secondary Outcomes (5)
Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery
Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
Cosmesis evaluation
participants will be followed until 6 months ± 1 month after last surgical treatment visit, an avarage of of 8 months following initial lumpectomy
Repeat lumpectomy rate
Participants will be followed for 2-5 weeks (average)
Repeat lumpectomy and mastectomy rate
Participants will be followed for 2-5 weeks (average)
Diagnostic Accuracy at the Patient Level (ignoring location)
Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
Study Arms (2)
SOC + Device
OTHERThe surgeon will perform routine standard of care lumpectomy with adjunctive MarginProbe device use on the main ex-vivo lumpectomy specimen.
SOC + Additional Inspection
OTHERThe surgeon will perform routine standard of care lumpectomy with additional inspection on the main ex-vivo lumpectomy specimen.
Interventions
The surgeon will use the MarginProbe System to identify cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision
The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
NorthShore University HealthSystem
Chicago, Illinois, 60201, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
John Hopkins Medicine
Baltimore, Maryland, 21287, United States
Suburban Hospital
Bethesda, Maryland, 20817, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
New Mexico University Cancer center
Albuquerque, New Mexico, 87102, United States
Montefiore Medical Center
New York, New York, 10461, United States
PinnacleHealth Cancer Institute
Harrisburg, Pennsylvania, 17109, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maya Livnat
Dilon Medical Technologies Ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2015
First Posted
April 2, 2015
Study Start
June 1, 2015
Primary Completion
September 1, 2021
Study Completion
November 1, 2021
Last Updated
August 18, 2021
Record last verified: 2021-07