MarginProbe® System U.S. Post-Approval Study

Breast Cancer Clinical Trial

Official title:

MarginProbe® System U.S. Post-Approval Study Protocol CP-07-001

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02406599
• Other study ID #: CP-07-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: November 2021

Study information

• Verified date: July 2021
• Source: Dune Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 440
• Est. completion date: November 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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:
• Control: Additional inspection
The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision

Locations

Country	Name	City	State
United States	New Mexico University Cancer center	Albuquerque	New Mexico
United States	John Hopkins Medicine	Baltimore	Maryland
United States	Summit Medical Group	Berkeley Heights	New Jersey
United States	Suburban Hospital	Bethesda	Maryland
United States	NorthShore University HealthSystem	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	PinnacleHealth Cancer Institute	Harrisburg	Pennsylvania
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	Montefiore Medical Center	New York	New York
United States	Moffitt Cancer Center	Tampa	Florida
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Dune Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Repeat lumpectomy rate	Proportion of patients who underwent a repeat lumpectomy procedure	Participants will be followed for 2-5 weeks (average)
Secondary	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)
Secondary	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

External Links

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