This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.
This study will evaluate a single intravenous dose of panitumumab-IRDye800 (pan800) in subjects with intracranial lesions who are scheduled to undergo standard-of-care neurosurgical resection. The study drug will be administered 1-5 days prior to surgery, after which participants will undergo their planned procedure with intraoperative near-infrared fluorescence imaging to assess tumor visualization. Following the infusion, subjects will be monitored for immediate adverse events, and a member of the study team will continue safety follow-up through postoperative assessments and a Day 15 follow-up contact. Participants will otherwise continue to receive standard-of-care evaluation and treatment for their intracranial disease at the discretion of their treating physicians.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Subjects receive a single infusion of panitumumab-IRDye800 (pan800) and will undergo near-infrared fluorescence imaging during their neurosurgical procedure 1-5 days after the infusion.
Determine the safety of panitumumab-IRDye800 as an imaging agent in patients undergoing surgery for intracranial lesions.
Safety will be defined by the number of Grade ≥ 2 AEs determined that are clinically significant and considered definitely or probably related to pan800. Safety data will be summarized by grade, severity, and type.
Time frame: From infusion to 15 days post-infusion.
Determine the efficacy of panitumumab-IRDye800 in identifying intracranial lesions compared to surrounding normal central nervous system tissue.
Efficacy will be measured by tumor-to-background ratio (TBR) using fluorescence intensity measurements.
Time frame: Within 14 days post-surgery
Determine the dosage of the study drug infusion to maximize the tumor-to- background ratio.
There will be an assessment of tumor-to-background ratio (TBR) comparing cohort 1 \& 2.
Time frame: Within 14 days post-surgery
Determine the optimal timing of the study drug infusion to maximize the tumor-to- background ratio.
There will be an assessment of tumor-to-background ratio (TBR). Some patients may receive the study drug on varying pre-surgery days rather than infusions on the same day for every patient. The TBR will be assessed for every patient regardless of pre-surgery infusion day. The optimal timing of administration of the study drug will be determined by the highest average TBR from a particular pre-surgery infusion day. TBR will still be assessed using the intraoperative fluorescence imaging taken on the standard of care surgery.
Time frame: Within 14 days post-surgery
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