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NCT05900986 · ClinicalTrials.gov registry record · Phase 1
LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer
A Phase 1 study of Breast Cancer and DCIS, sponsored by Integro Theranostics.
- Active
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 9
- Study locations
NCT05900986 is a Phase 1 study of Breast Cancer and DCIS that is active but no longer recruiting, run by Integro Theranostics. The registered enrollment target is 100 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 9 study locations across 8 states.
The verdict
NCT05900986, a Phase 1 study of Breast Cancer and DCIS, is active but no longer recruiting, sponsored by Integro Theranostics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 9
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-07-14 |
| Est. Completion | 2026-05 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is Integro Theranostics, which has 3 total studies on file at ClinicalTrials.gov.
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.
NCT05900986 reports 9 study locations spanning 8 distinct geographic areas - top geographies include Texas, Arizona, District of Columbia.
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.
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).
Who is sponsoring clinical trial NCT05900986?
This trial is sponsored by Integro Theranostics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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