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

ClinicalTrials.gov ID: NCT05900986

Public ClinicalTrials.gov record NCT05900986. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 10, 2026, 5:51 PM EDT

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05900986
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Integro Theranostics; Industry
Enrollment: 22 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 80 Years
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jul 13, 2023
Primary completion: Oct 5, 2025
Completion: May 5, 2026
Last update posted: May 19, 2026

2023 – 2026

United States locations

U.S. sites: 9
U.S. states: 8
U.S. cities: 9

Facility	City	State	ZIP	Site status
Integro Theranostics Research Site #2	Scottsdale	Arizona	85260	—
Integro Theranostics Research Site #12	Washington D.C.	District of Columbia	20059	—
Integro Theranostics Research Site #9	Weston	Florida	33331	—
Integro Theranostics Research Site #6	The Bronx	New York	10461	—
Integro Theranostics Clinical Research Site #8	Winston-Salem	North Carolina	27103	—
Integro Theranostics Research Site #10	Cleveland	Ohio	44195	—
Integro Theranostics Research Site #5	Philadelphia	Pennsylvania	19107	—
Integro Theranostics Research Site #3	Dallas	Texas	75290	—
Integro Theronostics Research Site #1	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05900986, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 19, 2026 · Synced Sep 10, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05900986 live on ClinicalTrials.gov.

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