A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies

Launched by ONCONANO MEDICINE, INC. · Sep 16, 2021

Keywords

ClinConnect Summary

This single-arm trial will enroll patients with biopsy confirmed or a high clinical suspicion of a lung malignancy based on MRI, CT and/or PET imaging. A total of up to 40 patients will be enrolled in this trial. The sponsor reserves the right to perform an interim analysis following early enrollment (i.e., n ≤ 10 subjects) to determine the feasibility and benefit of pegsitacianine as an adjunct to standard of care surgical resection of lung malignancies.

The surgeon will begin by attempting to perform their SOC tumor resection. If the tumor is unable to be located under standard white lig...

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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