MarginProbe® System U.S. Post-Approval Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Margin Probe; Other: Control: Additional inspection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Sibley Memorial Hospital
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist MD Anderson Cancer Center
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60201
      • Northshore University Healthsystem
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • John Hopkins Medicine
    • Bethesda, Maryland, United States, 20817
      • Suburban Hospital
  • New Jersey
    • Berkeley Heights, New Jersey, United States, 07922
      • Summit Medical Group
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico University Cancer center
  • New York
    • New York, New York, United States, 10461
      • Montefiore Medical Center
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17109
      • PinnacleHealth Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: SOC + Device; The surgeon will perform routine standard of care lumpectomy with adjunctive MarginProbe device use on the main ex-vivo lumpectomy specimen.	Device: Margin Probe; 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
OTHER: SOC + Additional Inspection; The surgeon will perform routine standard of care lumpectomy with additional inspection on the main ex-vivo lumpectomy specimen.	Other: Control: Additional inspection; The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery	Proportion of patients with 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	Objective evaluation by an evaluator blinded to arm assignment	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	Proportion of patients who underwent a repeat lumpectomy procedure	Participants will be followed for 2-5 weeks (average)
Repeat lumpectomy and mastectomy rate	Proportion of patients who underwent a repeat lumpectomy procedure or a mastectomy	Participants will be followed for 2-5 weeks (average)
Diagnostic Accuracy at the Patient Level (ignoring location)	Proportion of patients from whom shavings were taken	Participants will be followed only for the initial lumpectomy duration. information will be available 2-3 weeks (avarage) from initial lumpectomy date

Collaborators and Investigators

• Sponsor: Dune Medical Devices
• Investigators: Study Director: Maya Livnat, Dilon Medical Technologies Ltd.

Publications and helpful links

Helpful Links

• A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies.
• Dune Medical Devices official website

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2015
• Primary Completion (ANTICIPATED): September 1, 2021
• Study Completion (ANTICIPATED): November 1, 2021

Study Registration Dates

• First Submitted: March 24, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (ESTIMATE): April 2, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CP-07-001