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.
Subjects with intracranial lesions undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are deemed to be candidates for resection.
Subject age ≥ 18 years.
Chemistry Panel - Potassium, BUN (or urea), and Creatinine
CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count
Had a myocardial infarction, cerebrovascular accident, or uncontrolled chronic heart failure within 6 months prior to enrollment.
History of infusion reactions to any monoclonal antibody therapies.
Women who are currently pregnant or breastfeeding.
Participants presenting with a baseline QTcF interval > than 480 milliseconds.
Single group
Panitumumab-IRDye800
DrugSubjects 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.
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.
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.
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.
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Eben Rosenthal
Lead sponsor
Vanderbilt-Ingram Cancer Center
Sponsor institution
