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Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Patients Undergoing Lung Cancer Resection for Non Small Cell Lung Cancer
Sponsor: Integro Theranostics
Summary
The aim of this Phase 2 study is to investigate the efficacy and safety of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by intravenous (IV) infusion in patients undergoing VATS (Video-Assisted Thoracoscopic Surgery) or RATS (Robotic-Assisted Thoracoscopic Surgery) resection of Stage I-II non-small cell lung cancer (NSCLC).
Official title: A Phase 2, Open-Label, Multicenter Study to Investigate the Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Lung Cancer Resection
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2025-12-08
Completion Date
2026-09
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
LS301-IT 0.1 mg/kg
Single dose of LS301-IT administed up to 4 days prior to surgery
Locations (1)
University of Pennsylvania
Philadelphia, Pennsylvania, United States