Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

NCT05456373 | Unknown FDA Device

• 1 other identifier: LSB-12345
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; lumpectomy; positive surgical margins

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• FN and FP rates

  within weeks post-op

Study Arms (2)

SoC+ClearEdge device - Standard of Care + study device

EXPERIMENTAL

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

Device: ClearEdge device

SoC - Standard of Care

NO INTERVENTION

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

Interventions

ClearEdge device 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+ClearEdge device - Standard of Care + study device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are female (genotype)
• Patients aged above 18 years, inclusive
• Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure
• Patients treated with neoadjuvant endocrine therapy may be enrolled

You may not qualify if:

• Patients currently receiving chemotherapy
• Patients having prior ipsilateral surgical treatment for breast cancer
• 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)
• Patients who have breast implants
• Patients who are pregnant and/or lactating
• Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.

Sponsors & Collaborators

• LS BioPath: lead

Study Sites (1)

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Jasmine Wong, MD

  University of California, San Francisco Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moshe Sarfaty, PhD

CONTACT

408-464-4051; moshe@lsbiopath.com

Catherine Kusnick, MD

CONTACT

9496369601; ckusnick@alum.wellesley.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multi-center, pivotal prospective, randomized clinical trial of the effect of imaging the excision specimen during surgical treatment of breast cancer

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 13, 2022
• Study Start: October 10, 2022
• Primary Completion: August 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 22, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)