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
\*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
Brief Title
MarginProbe® System U.S. Post-Approval Study
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Breast Cancer
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)
* 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)
Inclusion 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
* 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
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02406599
Org Class
Industry
Org Full Name
Dune Medical Devices
Org Study Id
CP-07-001
Overall Status
Unknown status
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
MarginProbe® System U.S. Post-Approval Study Protocol CP-07-001
Primary Outcomes
Outcome Description
Sensitivity and Specificity at the margin level;
Outcome Measure
Diagnostic accuracy at the margin level
Outcome Time Frame
Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
Outcome Description
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).
Outcome Measure
Incomplete Surgical Resection (ISR )
Outcome Time Frame
Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
Secondary Outcomes
Outcome Description
Proportion of patients with Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery
Outcome Time Frame
Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
Outcome Measure
Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery
Outcome Description
Objective evaluation by an evaluator blinded to arm assignment
Outcome Time Frame
participants will be followed until 6 months ± 1 month after last surgical treatment visit, an avarage of of 8 months following initial lumpectomy
Outcome Measure
Cosmesis evaluation
Outcome Description
Proportion of patients who underwent a repeat lumpectomy procedure
Outcome Time Frame
Participants will be followed for 2-5 weeks (average)
Outcome Measure
Repeat lumpectomy rate
Outcome Description
Proportion of patients who underwent a repeat lumpectomy procedure or a mastectomy
Outcome Time Frame
Participants will be followed for 2-5 weeks (average)
Outcome Measure
Repeat lumpectomy and mastectomy rate
Outcome Description
Proportion of patients from whom shavings were taken
Outcome Time Frame
Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date
Outcome Measure
Diagnostic Accuracy at the Patient Level (ignoring location)
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Sheldon Feldman
Investigator Email
sfeldman@montefiore.org
Investigator Phone