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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the addition of a new imaging device, the ClearEdge, during breast cancer surgeries can help doctors find and remove cancer cells more effectively. The goal is to reduce the need for repeat surgeries by improving the detection of cancerous cells at the edges of tissue removed during a lumpectomy, a surgery to remove part of the breast. Women diagnosed with ductal carcinoma in situ (DCIS) or invasive breast cancer who are scheduled for a lumpectomy might be suitable candidates for this trial.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

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.

What prior data suggests that the ClearEdge device is safe for breast cancer surgery?

Research shows that surgeons have successfully used the ClearEdge device to find cancerous tissue during breast surgeries, reducing the likelihood of additional surgeries. However, the device sometimes mistakenly identifies healthy tissue as cancerous, occurring in 18.1% to 24.4% of cases, and occasionally misses cancerous tissue, occurring in 12.7% to 15.7% of cases. Despite these rates, the device is generally reliable.

Past studies indicate that using the ClearEdge device during surgery did not cause any major harm to patients. It helps doctors identify where cancer might remain after tumor removal through a special type of imaging, aiming to remove as much cancerous tissue as possible in one surgery.

Overall, the ClearEdge device appears to be a safe option for improving breast cancer surgery outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ClearEdge Device because it offers a novel way to assess surgical margins during breast cancer surgeries, which could potentially enhance the precision of lumpectomies. Unlike the standard of care, which relies solely on visual and tactile assessments, the ClearEdge Device uses advanced imaging technology to detect cancer cells at the margins of the excised tissue. This could reduce the likelihood of leaving cancerous cells behind, minimizing the need for additional surgeries. By improving margin assessment, this device aims to increase the effectiveness of breast-conserving surgeries, offering a significant advancement over traditional methods.

What evidence suggests that the ClearEdge device is effective for breast cancer surgery?

Research shows that the ClearEdge device, which participants in this trial may receive, can improve breast cancer surgery outcomes. It uses advanced imaging to detect cancer at the edges of the tissue removed during surgery. Studies have found that the device rarely errs, with false positive and false negative rates ranging from about 12% to 24%. This accuracy in identifying cancerous tissue may reduce the need for additional surgeries. Specifically, the use of the ClearEdge device significantly decreased the number of repeat surgeries, suggesting it effectively ensures complete cancer removal in one procedure. ^{1 2 3 4 6}

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. clinicaltrials.gov clinicaltrials.gov/study/NCT05456373

Intraoperative Use of ClearEdge Device in Breast ... ClearEdge tissue imaging device uses a new technology to detect tissue abnormalities at the surgical margins of a surgically excised breast tissue specimen.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798316308368

Intra-operative assessment of excised breast tumour ... The false positive rate (18.1% and 24.4%) and false negative rate (15.7% and 12.7%) were low in both phases. In Phase-2 re-excision rate was 37%, but in the 54 ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/350445

Intraoperative Use of ClearEdge Device in Breast ... ClearEdge tissue imaging device uses a new technology to detect tissue abnormalities at the surgical margins of a surgically excised breast tissue specimen.

4. withpower.com withpower.com/trial/phase-breast-neoplasms-7-2022-fb807

ClearEdge Device for Breast Cancer Surgery This trial is testing whether using the ClearEdge imaging device during breast cancer surgery can help doctors remove all cancerous tissue in one go, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8825505/

Development of intraoperative assessment of margins in ... We intend to provide an informative and up-to-date summary on the topic of intraoperative assessment of margins in breast conserving surgery (BCS).

6. nature.com nature.com/articles/s41523-025-00818-8

Breast cancer Intraoperative Margin Assessment using ... Positive margins of IDC on histopathology were observed in 29% (9/31) of cases, as shown in Table 3. In this study, specimen PET-CT was ...