Real-time Visualization During Breast Cancer Surgery to Check for Cancer Cells

Sponsor: Samuel Achilefu

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02807597

Provider View

This study is testing a new method using special goggles and a dye called LS301 to help surgeons see cancer cells during breast cancer surgery. The goal is to reduce the number of patients needing additional surgery by accurately identifying cancer cells left behind.

Patient Parameters

Program Overview

This study is exploring a new technique to help surgeons see cancer cells during breast cancer surgery using special goggles and a dye called LS301. The aim is to reduce the number of patients who need more surgery by accurately identifying any remaining cancer cells. The study will first test the safety and best dose of LS301, and then see how well it works in identifying cancer cells during surgery.

Description

The study is divided into two phases. In Phase 1, researchers will test the safety and best dose of LS301, a dye that helps highlight cancer cells during surgery. This phase will involve a small group of patients to find the safest and most effective dose. Once the best dose is determined, Phase 2 will begin.

In Phase 2, the study will test how well the dye works in helping surgeons identify cancer cells during breast cancer surgery. After the surgery, a second doctor will use special goggles to look at the removed tissue and check for any cancer cells. The tissue will also be examined by a pathologist to confirm the results. This study started at Washington University in St. Louis and is now continuing at UTSW. The results from Phase 1 will be reviewed by the FDA before moving on to Phase 2, which will involve more patients to further test the effectiveness of the dye in identifying cancer cells during surgery.

Eligibility Criteria

Inclusion Criteria

  • Newly diagnosed with Stage I-II breast cancer and undergoing breast-conserving surgery and SLN biopsy.
  • No signs of cancer in the lymph nodes based on a clinical exam.
  • At least 18 years old.
  • Able to understand and willing to sign a consent form.

Exclusion Criteria

  • Cannot have surgery for medical reasons.
  • Currently taking any experimental drugs.
  • History of allergic reactions to similar dyes or substances, including iodine or seafood allergies.
  • Have lung disease.
  • Pregnant women cannot participate; a negative pregnancy test is required before joining the study.
  • Breastfeeding women cannot participate due to potential risks to the infant.

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