What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving breast-conserving surgery followed by adjuvant therapies, have several known side effects. Radiation therapy can cause acute skin toxicity, including dermatitis, and long-term effects such as changes in skin texture and color, as well as fatigue. Endocrine therapies, such as tamoxifen and aromatase inhibitors, can lead to hot flashes, joint pain, and an increased risk of bone density loss and cardiovascular issues. These side effects are important considerations for patients undergoing breast-conserving treatments.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that focus on improving surgical outcomes and reducing recurrence. Notably, trastuzumab (Herceptin) has been approved for HER2-positive breast cancer, often used in combination with chemotherapy to target cancer cells more effectively. Additionally, the use of intraoperative imaging devices like the MarginProbe System has been approved to help surgeons achieve clear margins during lumpectomy procedures. These treatments and technologies aim to enhance the precision of cancer removal and minimize the need for repeat surgeries, aligning with the goals of the ClearEdge Imaging Device trial.

What other types of research exist?

Promising novel alternatives to the ClearEdge Imaging Device for enhanced detection of cancer margins in breast cancer patients include label-free optical imaging technologies and fluorescence navigation during oncologic surgery. These technologies are being actively researched and have shown potential in improving intraoperative assessment and guidance in surgical oncology.

← Back to Search

ClearEdge Device for Breast Cancer Surgery

N/A

Recruiting

Led By Jasmine Wong, MD

Research Sponsored by LS BioPath

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure

Patients aged above 18 years, inclusive

Must not have

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 having prior ipsilateral surgical treatment for breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within weeks post-op

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a diagnostic device used during surgery rather than a drug, typical medication side effects aren't expected. However, there may be risks associated with its use during an operation that will be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I am currently undergoing chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in the operating room compared to pathology assessment within 1 week post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in the operating room compared to pathology assessment within 1 week post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and in the operating room compared to pathology assessment within 1 week post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of subjects with positive margins post-op

Secondary study objectives

FN and FP rates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SoC+ClearEdge device - Standard of Care + study deviceExperimental Treatment1 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 CareActive Control1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments primarily include surgery, radiation therapy, endocrine therapy, and chemotherapy. Surgery, such as lumpectomy or mastectomy, physically removes the tumor, and accurate margin detection is crucial to ensure all cancerous tissue is excised, reducing the need for repeat surgeries. The ClearEdge Imaging Device aims to enhance this process by improving the detection of cancer margins. Radiation therapy uses high-energy rays to kill remaining cancer cells post-surgery, reducing local recurrence. Endocrine therapy blocks hormones like estrogen that fuel certain breast cancers, while chemotherapy uses drugs to target and kill rapidly dividing cancer cells. These treatments are essential for reducing recurrence, managing symptoms, and improving survival rates in breast cancer patients.