A Phase 1/2 interventional study of Panitumumab-IRDye800 and Pinpoint-IR9000 endoscopic/handheld device in Brain Tumor, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 6 Months to 25 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Stanford University · Phase 1/2, Interventional, and Diagnostic
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Primary objective: is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Secondary Objective:
Pediatric subjects will undergo standard of care, histopathologically-based, surgical resection of tumor 1 to 5 days after infusion of Panitumumab-IRDye800. Intraoperative imaging will be performed using an intraoperative optical imaging devices and wide-field imaging devices.
Back table imaging of the resection tissue (ex vivo) will be also performed with the wide-field device. Ex vivo imaging of the specimens prior to and during pathological assessment will be performed using the non-invasive, close field imaging device that does not violate or destroy the tissue. Additional imaging devices used solely on the back table are not included in this record, as the data is collected is not used for medical decisions and such devices are therefore not interventions.
Pediatric subjects will be followed for 30 days following their study infusion with scheduled follow up visits on the day of surgery (Day 1 5), Day 15, and Day 30.
Exclusion Criteria:
Dose: 0.006 Panitumumab-IRDye800 (mg/kg)
Drug: Panitumumab-IRDye800 · Device: Pinpoint-IR9000 endoscopic/handheld device · Device: Explorer Air camera · Device: PDE-NEO-II
Dose: 0.25 Panitumumab-IRDye800 (mg/kg)
Drug: Panitumumab-IRDye800 · Device: Pinpoint-IR9000 endoscopic/handheld device · Device: Explorer Air camera · Device: PDE-NEO-II
Dose: 0.50 Panitumumab-IRDye800 (mg/kg)
Drug: Panitumumab-IRDye800 · Device: Pinpoint-IR9000 endoscopic/handheld device · Device: Explorer Air camera · Device: PDE-NEO-II
Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)
Drug: Panitumumab-IRDye800 · Device: Pinpoint-IR9000 endoscopic/handheld device · Device: Explorer Air camera · Device: PDE-NEO-II
Panitumumab-IRDye800 is an imaging agent prepared as a drug-dye compound from panitumumab (Vectibix), a fully-humanized IgG2 monoclonal anti-epidermal growth factor receptor (EGFR) antibody, and IRDye800CW dye. Panitumumab-IRDye800 delivered intravenous (IV).
Novadaq intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).
Surgvision intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).
Hamamatsu Photonics KK intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).
Toxicities (related adverse events)
Adverse events related to the agent or procedure are considered toxicities, and is assessed as the number of Grade 2 or higher adverse events which have been determined to be clinically-significant and definitely, probably, or possibly-related to the study treatment or procedure. The outcome is reported by dose treatment group (cohort) as a number without dispersion.
Time frame: 30 days
Panitumumab-IRDye800 Fluorescence Intensity
Dosing of panitumumab-IRDye800 in the study participants will be assessed on the basis of fluorescence intensity, determined as the ratio of fluorescence intensity in tumor tissue to that of normal tissue. This is known as the tumor-to-background ratio (TBR). The outcome will be reported by dose treatment group (cohort) as the mean TBR with standard deviation.
Time frame: 5 days
Tumor-to-background Ratio (TBR) Sensitivity and Specificity for Optimal Dose Level
The merit of Panitumumab-IRDye800 to identify pediatric tumors during surgery will be assessed as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (PPV), based on the actual histopathological diagnosis for the excised lesions. * Sensitivity is the "true positive rate" (by histopathology), expressed as a proportion (ratio) * Specificity is the "true negative rate," expressed as a proportion * Positive predictive value (PPV) is the proportion of tumor-positive samples that were actually cancer; * Negative predictive value (NPV) is the proportion of tumor-negative samples that were not cancer. Per protocol, the analysis is only conducted for those participants who were treated with the optimal dose level. Higher values indicate greater merit. The outcome will be reported per protocol for the optimal dose level as the sensitivity; specificity; PPV; and NPV, with 95% confidence interval.
Time frame: 7 days
Plan to share: No
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