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ACTIVE NOT RECRUITING Phase 1

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

NCT05900986 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG LS301-IT 0.1 mg/kg
  • DRUG LS301-IT 0.025 mg/kg
  • DRUG LS301-IT 0.05 mg/kg
  • DRUG LS301-IT 0.075 mg/kg

Study Locations (9)

Texas

  • Integro Theranostics Research Site #3 — Dallas
  • Integro Theronostics Research Site #1 — Houston

Arizona

  • Integro Theranostics Research Site #2 — Scottsdale

District of Columbia

  • Integro Theranostics Research Site #12 — Washington D.C.

Florida

  • Integro Theranostics Research Site #9 — Weston

New York

  • Integro Theranostics Research Site #6 — The Bronx

North Carolina

  • Integro Theranostics Clinical Research Site #8 — Winston-Salem

Ohio

  • Integro Theranostics Research Site #10 — Cleveland

Pennsylvania

  • Integro Theranostics Research Site #5 — Philadelphia

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2023-07-14
Est. Completion 2026-05
Phase Phase 1

Sponsor

Integro Theranostics

34 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05900986

The ClinicalTrials.gov registry entry for NCT05900986 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Integro Theranostics, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which LS301-IT 0.1 mg/kg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05900986 reports 9 study locations spanning 8 distinct geographic areas — top geographies include Texas, Arizona, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05900986 about?

NCT05900986 is a clinical study titled "LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer". 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 ...

What is the current status of trial NCT05900986?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2023-07-14. Estimated completion is 2026-05.

What conditions does trial NCT05900986 study?

This clinical trial studies the following conditions: Breast Cancer, DCIS, Invasive Duct Carcinoma of Breast. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05900986?

The interventions under investigation include: LS301-IT 0.1 mg/kg (DRUG), LS301-IT 0.025 mg/kg (DRUG), LS301-IT 0.05 mg/kg (DRUG), LS301-IT 0.075 mg/kg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05900986?

This trial is sponsored by Integro Theranostics, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05900986 being conducted?

This trial has 9 study locations across Arizona, District of Columbia, Florida, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial