A Phase 2, Single-Dose, Open-Label 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
A Phase 2, Single-Dose, Open-Label 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
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.
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 light conditions, an appropriate FDA-cleared near-infrared imaging device may be used to aid in the location of the primary tumor. Localization of the primary tumor, when unable to be located using white light imaging, in conjunction with pathology confirmed presence of disease will be considered a clinically significant event. Following any standard of care procedures conducted under white light only, the near infrared camera will be used to evaluate areas of residual fluorescence that may be resected if suscpicious for metastatic spread or residual margins. The fluorescence status of each specimen will then be correlated to the final pathology for each, and performance metrics of pegsitacianine will be tabulated.
Inclusion Criteria:
Exclusion Criteria: