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Real-time Intraoperative Breast Cancer Visualization for Margin Assessment

NCT02807597 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-08-17

Study results available
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Summary

The investigators' preclinical data have demonstrated the feasibility of fluorescence-guided tumor resection by Cancer Vision Goggles (CVG) with LS301 in animal models. In this study, the investigators will conduct intraoperative imaging procedures that have minimal interference with ongoing surgery. The underlying hypothesis is that the accurate detection of all cancer cells highlighted by LS301 during surgery will reduce the number of breast cancer patients with margin positivity to less than 5%, compared to the current surgical paradigm of greater than 20%. The pilot study will obtain critical data required to address the larger question of surgical margin assessment in a full Phase I clinical trial.

Phase 1: to determine the safety and optimal imaging dose of LS301 injected in breast cancer patients.

Phase 2: to determine the ability of this novel fluorescence imaging agent to predict the presence of positive margins around partial mastectomy specimens and positive SLNs during surgical therapy for breast cancer.

Conditions

Interventions

DRUG

LS301

-LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond.

DEVICE

Cancer Vision Goggles and standard fluorescence imaging systems

-Member of the operating team will wear the CVG during surgery

PROCEDURE

Surgery

-Standard of care

Sponsors & Collaborators

  • Samuel Achilefu

    lead OTHER

Principal Investigators

  • Samuel Achilefu, Ph.D. · UT Southwestern Medical Center

  • Deborah Farr, M.D. · UT Southwestern Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-18
Primary Completion
2022-01-27
Completion
2022-01-27
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807597 on ClinicalTrials.gov