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MarginProbe® System U.S. Post-Approval Study

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ClinicalTrials.gov Identifier: NCT02406599
Recruitment Status : Active, not recruiting
First Posted : April 2, 2015
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
Dune Medical Devices

Study Description
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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


Condition or disease Intervention/treatment Phase
Breast Cancer Device: Margin Probe Other: Control: Additional inspection Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: MarginProbe® System U.S. Post-Approval Study Protocol CP-07-001
Actual Study Start Date : June 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

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Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic accuracy at the margin level [ Time Frame: 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;

  2. Incomplete Surgical Resection (ISR ) [ Time Frame: 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 :
  1. Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery [ Time Frame: 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

  2. Cosmesis evaluation [ 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 ]
    Objective evaluation by an evaluator blinded to arm assignment

  3. Repeat lumpectomy rate [ Time Frame: Participants will be followed for 2-5 weeks (average) ]
    Proportion of patients who underwent a repeat lumpectomy procedure

  4. Repeat lumpectomy and mastectomy rate [ Time Frame: Participants will be followed for 2-5 weeks (average) ]
    Proportion of patients who underwent a repeat lumpectomy procedure or a mastectomy

  5. Diagnostic Accuracy at the Patient Level (ignoring location) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406599


Locations
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United States, District of Columbia
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Illinois
NorthShore University HealthSystem
Chicago, Illinois, United States, 60201
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Maryland
John Hopkins Medicine
Baltimore, Maryland, United States, 21287
Suburban Hospital
Bethesda, Maryland, United States, 20817
United States, New Jersey
Summit Medical Group
Berkeley Heights, New Jersey, United States, 07922
United States, New Mexico
New Mexico University Cancer center
Albuquerque, New Mexico, United States, 87102
United States, New York
Montefiore Medical Center
New York, New York, United States, 10461
United States, Pennsylvania
PinnacleHealth Cancer Institute
Harrisburg, Pennsylvania, United States, 17109
Sponsors and Collaborators
Dune Medical Devices
Investigators
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Study Director: Maya Livnat Dilon Medical Technologies Ltd.
More Information
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Additional Information:

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Responsible Party: Dune Medical Devices
ClinicalTrials.gov Identifier: NCT02406599    
Other Study ID Numbers: CP-07-001
First Posted: April 2, 2015    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: July 2020