Lung Cancer Clinical Trial
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.
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
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There are 2 Locations for this study
Philadelphia Pennsylvania, 19104, United States
Houston Texas, 77030, United States
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