Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

NCT ID: NCT05456373

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SoC+ClearEdge device - Standard of Care + study device

Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery plus the use of the study device to assess for breast cancer cells at the the margins

Group Type: EXPERIMENTAL

ClearEdge device

Intervention Type: DEVICE

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.

SoC - Standard of Care

Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ClearEdge device

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

LS BioPath

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jasmine Wong, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco Medical Center

Locations

UCSF Medical Center at Mission Bay

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Moshe Sarfaty, PhD

Role: CONTACT

moshe@lsbiopath.com

408-464-4051

Catherine Kusnick, MD

Role: CONTACT

ckusnick@alum.wellesley.edu

9496369601

Facility Contacts

Jasmin Wong, MD

Role: primary

Jasmine.Wong2@ucsf.edu

415-353-7070

Other Identifiers

LSB-12345

Identifier Type: -

Identifier Source: org_study_id