LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer

Description

The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by efficacy that will be assessed from fluorescence imaging observations and data.

Conditions

Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast

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Study Overview

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Study Details

Study overview

The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) injection in female patients undergoing partial mastectomy for DCIS (whether or not undergoing planned SLNB) or Stage I-II primary invasive breast cancer undergoing SLNB. Safety is the primary objective of this study, followed by efficacy that will be assessed from fluorescence imaging observations and data.

An Open-label, Single-arm, Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of LS301-IT in Female Patients Undergoing Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for Ductal Carcinoma in Situ (DCIS) or Stage I-II Primary Invasive Breast Cancer

LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Integro Theranostics Research Site #2, Scottsdale, Arizona, United States, 85260

Washington

Integro Theranostics Research Site #12, Washington, District of Columbia, United States, 20059

Weston

Integro Theranostics Research Site #9, Weston, Florida, United States, 33331

Bronx

Integro Theranostics Research Site #6, Bronx, New York, United States, 10461

Winston-Salem

Integro Theranostics Clinical Research Site #8, Winston-Salem, North Carolina, United States, 27103

Cleveland

Integro Theranostics Research Site #10, Cleveland, Ohio, United States, 44195

Philadelphia

Integro Theranostics Research Site #5, Philadelphia, Pennsylvania, United States, 19107

Dallas

Integro Theranostics Research Site #3, Dallas, Texas, United States, 75290

Houston

Integro Theronostics Research Site #1, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * DCIS (whether or not undergoing planned SLNB) or patients with Stage I-II, primary invasive carcinoma of the breast undergoing SLNB for which the patient's primary surgical treatment is single breast partial mastectomy.
  • * ECOG performance status of 0 to 2
  • * Contraindications for surgery.
  • * Simultaneous bilateral lumpectomies and bilateral partial mastectomies.
  • * History of drug-related anaphylactic reactions, including those attributed to indocyanine green (ICG) or other agents used in the study
  • * Prior chemotherapy, endocrine therapy, or biologic therapy for current clinically or biopsy proven breast cancer for Period 1.
  • * Open surgery in the ipsilateral breast within a period of 1 year before administration of LS301-IT.
  • * History of radiation therapy to the chest.
  • * The lymphatic imaging agent ICG cannot be used prior to the partial mastectomy and SLNB procedures on the day of surgery.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Integro Theranostics,

Dan Thompson, STUDY_DIRECTOR, Integro Theranostics

Study Record Dates

2025-07