Real-time Intraoperative Breast Cancer Visualization for Margin Assessment

Launched by SAMUEL ACHILEFU · Jun 16, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help doctors see and remove all cancer cells during breast surgery using a special imaging tool called Cancer Vision Goggles (CVG) with a dye called LS301. The goal is to make sure that less than 5% of patients have leftover cancer cells after surgery, which is a big improvement compared to the current method that leaves more than 20% with positive margins (areas around the tumor that still have cancer). This trial is the first step to gather important information about how safe and effective this new approach is for breast cancer patients.

To be eligible for the trial, participants should be adults aged 18 or older who have recently been diagnosed with early-stage breast cancer and are planning to undergo surgery to remove the tumor while conserving breast tissue. They should not have any serious health issues that would prevent surgery, and they must be able to understand and sign a consent form to participate. Participants can expect to receive the LS301 dye before their surgery, and the study aims to find out the safest dose and how well this imaging tool can help identify any remaining cancer. It’s important to note that certain individuals, such as those who are pregnant or breastfeeding, cannot take part in this study due to potential risks.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Newly diagnosed Stage I-II breast cancer patients undergoing breast-conserving therapy and SLN biopsy.
• • Negative nodal basin clinical exam.
• • At least 18 years of age.
• • Able to understand and willing to sign a written informed consent document.
• Exclusion Criteria:
• • Contraindications for surgery.
• • Receiving any investigational agents.
• • History of allergic reactions attributed to ICG or other agents used in the study, include known iodide or seafood allergy. The investigators do not expect many of these adverse reactions with LS301 because it is not radioactive and does not possess iodinated counter ions.
• • Presence of underlying lung disease
• • Pregnant. Female patients of childbearing potential must have a negative serum or urine pregnancy test no more than 7 days before start of participation.
• • Breastfeeding. Patients who are breastfeeding are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with LS301.