ClearEdge Device for Breast Cancer Surgery

Overseen By Moshe Sarfaty, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: LS BioPath

Must be taking: Endocrine therapy

Must not be taking: Chemotherapy

Disqualifiers: Prior surgery, Radiation, Implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether using the ClearEdge imaging device during breast cancer surgery can help doctors remove all cancerous tissue in one go, reducing the need for repeat surgeries. The device helps surgeons see if the edges of the removed tissue still have cancer cells.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are currently receiving chemotherapy, you cannot participate in this trial.

How does the ClearEdge Device treatment differ from other breast cancer surgery treatments?

The ClearEdge Device is unique because it allows surgeons to check the edges of the removed breast tissue during surgery to ensure all cancerous cells are removed, reducing the need for additional surgeries. ^{1 2 3 4 5}

What data supports the effectiveness of the ClearEdge Device treatment for breast cancer surgery?

The ClearEdge Device is designed to help surgeons check if all cancerous tissue has been removed during breast cancer surgery, which is important to prevent cancer from coming back. Similar devices, like MarginProbe, have been shown to reduce the need for additional surgeries by helping ensure all cancerous tissue is removed in the first operation. ^{3 4 6 7 8}

Who Is on the Research Team?

Jasmine Wong, MD

Principal Investigator

University of California, San Francisco Medical Center

Are You a Good Fit for This Trial?

This trial is for women over 18 with breast DCIS or invasive cancer who are recommended for a lumpectomy. It's not open to those who've had previous surgery or radiation on the same breast, are pregnant or breastfeeding, currently on chemotherapy, have implants, or were in another surgical breast cancer study recently.

Inclusion Criteria

I have been diagnosed with breast cancer and recommended for a lumpectomy.

I have received hormone therapy before surgery for my cancer.

I am genetically female.

Exclusion Criteria

I've had radiation therapy for cancer in the same breast or for another cancer that included breast tissue.

I have not been in any breast cancer studies involving surgery in the last 6 months.

I have had surgery on the same side breast cancer before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo breast conserving surgery with or without the ClearEdge device for margin assessment

1 week

1 visit (in-person, surgery)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• ClearEdge Device

Trial Overview The trial is testing if using the ClearEdge device during surgery helps doctors better detect and remove all of the cancer compared to standard care. This could potentially reduce the need for additional surgeries. Participants will be randomly assigned to either use this device or follow usual procedures.

How Is the Trial Designed?

Group I: SoC+ClearEdge device - Standard of Care + study device Experimental Treatment 1 Intervention

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 II: SoC - Standard of Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

LS BioPath

Lead Sponsor

Trials

2

Recruited

410+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Intra-operative assessment of excised breast tumour margins using ClearEdge imaging device. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery. [2009]

3. United States pubmed.ncbi.nlm.nih.gov

Diagnostic performance of a novel device for real-time margin assessment in lumpectomy specimens. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The impact of use of an intraoperative margin assessment device on re-excision rates. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Creation of an Automated Fluorescence Guided Tumor Ablation System. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Image-guided surgery with a new tumour-targeting probe improves the identification of positive margins. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

The MarginProbe® System: An Innovative Approach to Reduce the Incidence of Positive Margins Found After Lumpectomy. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Current issues in the surgical management of breast cancer: a review of abstracts from the 2002 San Antonio Breast Cancer Symposium, the 2003 Society of Surgical Oncology annual meeting, and the 2003 American Society of Clinical Oncology meeting. [2019]