MarginProbe® System U.S. Post-Approval Study
- Conditions
- Breast Cancer
- Interventions
- Device: Margin Probe
- Registration Number
- NCT02406599
- Lead Sponsor
- Dune Medical Devices
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 440
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SOC + Device Margin Probe The surgeon will perform routine standard of care lumpectomy with adjunctive MarginProbe device use on the main ex-vivo lumpectomy specimen.
- Primary Outcome Measures
Name Time Method Diagnostic accuracy 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 Sensitivity and Specificity at the margin level;
Incomplete Surgical Resection (ISR ) Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date 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).
- Secondary Outcome Measures
Name Time Method 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 Proportion of patients with Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery
Repeat lumpectomy and mastectomy rate Participants will be followed for 2-5 weeks (average) Proportion of patients who underwent a repeat lumpectomy procedure or a mastectomy
Repeat lumpectomy rate Participants will be followed for 2-5 weeks (average) Proportion of patients who underwent a repeat lumpectomy procedure
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 Objective evaluation by an evaluator blinded to arm assignment
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 Proportion of patients from whom shavings were taken
Trial Locations
- Locations (11)
New Mexico University Cancer center
🇺🇸Albuquerque, New Mexico, United States
Baptist MD Anderson Cancer Center
🇺🇸Jacksonville, Florida, United States
Sibley Memorial Hospital
🇺🇸Washington, District of Columbia, United States
NorthShore University HealthSystem
🇺🇸Chicago, Illinois, United States
John Hopkins Medicine
🇺🇸Baltimore, Maryland, United States
PinnacleHealth Cancer Institute
🇺🇸Harrisburg, Pennsylvania, United States
Suburban Hospital
🇺🇸Bethesda, Maryland, United States
Summit Medical Group
🇺🇸Berkeley Heights, New Jersey, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Montefiore Medical Center
🇺🇸New York, New York, United States