Actively Recruiting
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
Led by Integro Theranostics · Updated on 2026-04-20
35
Participants Needed
2
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a primary diagnosis or strong suspicion of lung cancer based on CT, biopsy, or imaging
- Scheduled for lung tumor removal surgery using thoracoscopy
- For those who can become pregnant, negative serum pregnancy test before dosing and use of medically accepted contraception or abstinence
- Able to understand and follow study requirements
You will not qualify if you...
- Medical conditions or contraindications that make surgery unsafe
- History of drug-related allergic or anaphylactic reactions, including to indocyanine green or other contrast agents
- Impaired kidney function
- Clinically significant ECG abnormalities or heart conduction issues
- Prior radiation therapy to the chest
- Elevated total bilirubin levels above 1.5 times the upper limit
- Elevated liver enzymes (AST/SGOT or ALT/SGPT) above 2.5 times the upper limit
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
2
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
J
Jim Joffrion
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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