Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

LS BioPath288 enrolled

Overview

Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.

ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons successfully used the device to identify DCIS or invasive cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was clinically evaluated by several hospitals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

288

Conditions

Breast Cancer

Interventions

ClearEdge deviceDEVICE

ClearEdge tissue imaging device uses a new technology to detect tissue abnormalities at the surgical margins of a surgically excised breast tissue specimen. Adding the use of the imaging device has the potential to assist the surgeon in identifying DCIS or invasive cancer involved margins of the excised specimen.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who are female (genotype) 2. Patients aged above 18 years, inclusive 3. Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure 4. Patients treated with neoadjuvant endocrine therapy may be enrolled Exclusion Criteria: 1. Patients currently receiving chemotherapy 2. Patients having prior ipsilateral surgical treatment for breast cancer 3. Patients who have had radiation therapy for ipsilateral breast cancer or for other malignancy that includes breast tissue in the radiation field (e.g. Hodgkin's lymphoma) 4. Patients who have breast implants 5. Patients who are pregnant and/or lactating 6. Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.

Locations (1)

UCSF Medical Center at Mission Bay

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

Percentage of subjects with positive margins post-op

The percentage of patients with DCIS or invasive cancer involved margins as determined by pathology PM after evaluation with SoC or SoC+ClearEdge.

Time frame: In the operating room compared to pathology assessment within 1 week post-op

Secondary Outcomes

FN and FP rates

The per-patient FN rate and FP rate for SoC compared to permanent section pathology

Time frame: within weeks post-op

Central Contacts

Moshe Sarfaty, PhD

CONTACT

408-464-4051 moshe@lsbiopath.com

Catherine Kusnick, MD

CONTACT

9496369601 ckusnick@alum.wellesley.edu

Data from ClinicalTrials.gov

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