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A Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies in Patients Undergoing Routine Surgery Summary This Phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery .
View Eligibility Criteria Eligibility Criteria Inclusion Criteria: Biopsy confirmed diagnosis, or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging Exclusion Criteria: Known hypersensitivity or allergy to indocyanine green (ICG), polymethylmethacrylate (PMMA; found in dental and bone cements) or polyethylene glycol (PEG) Tumor locations the surgeon deems unfeasible to image intraoperatively Excessive and/or generalized disease deemed inoperable by the surgeon Life expectancy less than 12 weeks
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 2 Locations for this study
Hospital of the University of Pennsylvania Philadelphia Pennsylvania, 19104, United States
The University of Texas MD Anderson Cancer Center Houston Texas, 77030, United States
How clear is this clinincal trial information?
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