Recruiting

ClearEdge Device

Sponsor:

LS BioPath

Code:

NCT05456373

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ClearEdge device

Study Details

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

Study ID

NCT05456373

Start date

Oct 10, 2022

Status verified date

Jul, 2022

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Aug 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

288 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

no intervention: SoC - Standard of Care

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

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.

Primary outcome measure

  • Percentage of subjects with positive margins post-op [ Time Frame: In the operating room compared to pathology assessment within 1 week post-op ]

Central Contacts and Locations

Central contacts

Moshe Sarfaty, PhD

408-464-4051moshe@lsbiopath.com

Catherine Kusnick, MD

9496369601ckusnick@alum.wellesley.edu

Locations

UCSF Medical Center at Mission Bay

Recruiting

San Francisco, California, United States, 94158

Contacts

Jasmin Wong, MD

415-353-7070Jasmine.Wong2@ucsf.edu

More Information

Sponsor

LS BioPath

Last update posted

Mar 22, 2023

Last verified

Jul, 2022

Keywords

  • breast cancer
  • lumpectomy
  • positive surgical margins

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LS BioPath on 2023-03-22.