MarginProbe® System U.S. Post-Approval Study

Sponsor

Dune Medical Devices (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02406599

Collaborator

(none)

440

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Sibley Memorial Hospital	Washington	District of Columbia	United States	20016
2	Baptist MD Anderson Cancer Center	Jacksonville	Florida	United States	32207
3	Moffitt Cancer Center	Tampa	Florida	United States	33612
4	NorthShore University HealthSystem	Chicago	Illinois	United States	60201
5	Rush University Medical Center	Chicago	Illinois	United States	60612
6	John Hopkins Medicine	Baltimore	Maryland	United States	21287
7	Suburban Hospital	Bethesda	Maryland	United States	20817
8	Summit Medical Group	Berkeley Heights	New Jersey	United States	07922
9	New Mexico University Cancer center	Albuquerque	New Mexico	United States	87102
10	Montefiore Medical Center	New York	New York	United States	10461
11	PinnacleHealth Cancer Institute	Harrisburg	Pennsylvania	United States	17109

Sponsors and Collaborators

Dune Medical Devices

Investigators

Study Director: Maya Livnat, Dilon Medical Technologies Ltd.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Dune Medical Devices

ClinicalTrials.gov Identifier:

NCT02406599

Other Study ID Numbers:

CP-07-001

First Posted:

Apr 2, 2015

Last Update Posted:

Aug 18, 2021

Last Verified:

Jul 1, 2021

Study Results

No Results Posted as of Aug 18, 2021