Real-time Intraoperative Breast Cancer Visualization for Margin Assessment

NCT02807597 | Terminated Phase 1 Results DMC FDA Drug FDA Device

• 1 other identifier: STU-2022-0385
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer; Cancer of the Breast

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Related Adverse Events of LS301 in Breast (Phase I)

  -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting.

  Time of injection to 3 hours post-injection

• Number of Participants Receiving Optimal Imaging Dose of LS301 (Phase I)

  * Optimal dose will be the dose at which fewer than 2 dose-limiting toxicities (DLTs) are observed and optimal image quality is observed. It need not be the maximum tolerated dose (MTD) if optimal image quality is observed at a lower dose than the MTD. * DLT is defined as any grade 2 or above toxicity that occurs during the hour after injection that is considered possibly, probably, or definitely related to LS301 * Toxicities will be graded using the NCI Common Terminology Criteria for Adverse Events version 5.0

  14-15 months

• Ability of LS301 to Predict Presence of Positive Margins Around Partial Mastectomy (Phase II)

  -The histopathological results of margin positivity has the following possible results: margin negative, margin positive at LS301 and CVG identified locations, margin positive at LS301 and CVG unidentified locations. Using LS301 and CVG, the exercised tissue will be considered to be margin positive and have ink marked at the identified locations if any positive margins are observed; otherwise, the margin is considered negative. Diagnostic test characteristics (sensitivity and specificity) of LS301 and CVG for margin positivity by histology will established and margin positivity rate, defined as the proportion of tumors with histopathologically confirmed positive margins but missed by CVG, will be estimated.

  Day 1 (at the time of surgery)

Secondary Outcomes (1)

• Toxicity of LS301 in Breast as Measured by Related Adverse Events (Phase II)

  up to 48 hours post LS301 injection

Study Arms (5)

Phase I Dose Level 1: LS301

EXPERIMENTAL

* Patient will undergo surgery 4-24 hours after administration of LS301 (0.05 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data.

Drug: LS301; Device: Cancer Vision Goggles and standard fluorescence imaging systems; Procedure: Surgery

Phase I Dose Level 2: LS301

EXPERIMENTAL

* Patient will undergo surgery 4-24 hours after administration of LS301 (0.075 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data.

Drug: LS301; Device: Cancer Vision Goggles and standard fluorescence imaging systems; Procedure: Surgery

Phase I Dose Level 3: LS301

EXPERIMENTAL

* Patient will undergo surgery 4-24 hours after administration of LS301 (0.1 mg/kg) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data.

Drug: LS301; Device: Cancer Vision Goggles and standard fluorescence imaging systems; Procedure: Surgery

Phase I Dose Expansion: LS301

EXPERIMENTAL

* Patient will undergo surgery 4-24 hours after administration of LS301 (dose to be determined in Phase I dose escalation portion) * 9 patients will be enrolled (6 invasive ductal carcinoma and 3 DCIS) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data.

Drug: LS301; Device: Cancer Vision Goggles and standard fluorescence imaging systems; Procedure: Surgery

Phase II: LS301

EXPERIMENTAL

* Patient will undergo surgery 4-24 hours after administration of LS301 (dose to be determined in Phase I portion) * Excised tissue will be examined for the presence of LS301 fluorescence using the Cancer Vision Goggles (CVG) to determine if LS301 accumulated in the breast cancer. The investigators will quantify fluorescence intensity in the cancer to establish the feasibility of observing LS301 fluorescence with the imaging system. FDA-approved fluorescence imaging systems may be used to benchmark CVG data.

Drug: LS301; Device: Cancer Vision Goggles and standard fluorescence imaging systems; Procedure: Surgery

Interventions

LS301 DRUG

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

Phase I Dose Expansion: LS301; Phase I Dose Level 1: LS301; Phase I Dose Level 2: LS301; Phase I Dose Level 3: LS301; Phase II: LS301

Cancer Vision Goggles and standard fluorescence imaging systems DEVICE

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

Also known as: CVG

Phase I Dose Expansion: LS301; Phase I Dose Level 1: LS301; Phase I Dose Level 2: LS301; Phase I Dose Level 3: LS301; Phase II: LS301

Surgery PROCEDURE

-Standard of care

Phase I Dose Expansion: LS301; Phase I Dose Level 1: LS301; Phase I Dose Level 2: LS301; Phase I Dose Level 3: LS301; Phase II: LS301

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samuel Achilefu: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Before LS301's licensing and reformulation, 9 patients received LS301-HSA (Phase 1a) , but since no patients were recruited (in Phase 1b) before the product expired, this study has been terminated. Therefore, no data was collected and reported for phase 1b and phase 2.

Results Point of Contact

• Title: Dr. Samuel Achilefu
• Organization: UT Southwestern Medical Center

Samuel.Achilefu@UTSouthwestern.edu

314-362-8599

Study Officials

• Samuel Achilefu, Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Deborah Farr, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor & Chair

Model Details: A rolling six design will be used to enroll patients in the phase I dose escalating portion of the study.

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: June 21, 2016
• Study Start: February 18, 2020
• Primary Completion: January 27, 2022
• Study Completion: January 27, 2022
• Last Updated: August 17, 2025
• Results First Posted: August 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)