Fluorescence imaging agent for lung cancer resection
Brief description of study
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV) administration in patients undergoing surgical thoracoscopy and resection of lung cancer. Safety is the primary objective of this study, followed by the evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making during the surgical resection. Pulmonary resection is recommended for most patients who have Stage I-II non-small cell lung cancer (NSCLC). The goal is complete resection, minimize unnecessary resections, and accurate staging. Challenges include identification of small nodules, recognition of synchronous cancers or advanced cancers, and confirmation of negative margins. These challenges are magnified because of the increasing use of minimally invasive surgery where tactile feedback is reduced and chest assessment is compromised (Gangadharan, 2020). To assess the safety and tolerability of a single IV administration of LS301-IT To assess up to 4 doses of LS301-IT (starting at 0.025 mg/kg with either escalation or de- escalation) to optimize the intraoperative fluorescence visualization of tissue types based on semi-quantitative surgeon scoring
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: - 99 Years
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Gender: All
TBD
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