At a glance
ClinicalIndex Comparison Record- ✓Suspected brain tumors undergoing surgical removal as standard of care
- ✓May include subjects status post chemotherapy and/or radiation or diagnostic biopsy candidates for resection
- ✓Eligible for resection as determined by operating surgeon
- ✓Planned standard of care surgery
- ✕Investigational drug within 30 days prior to first dose
- ✕Myocardial infarction, cerebrovascular accident, uncontrolled CHF, significant liver disease, or unstable angina within 6 months
- ✕History of infusion reactions to monoclonal antibody therapies
- ✕Pregnant or breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1/Phase 2, Open Label Study Evaluating the Safety, Dosing and Efficacy of Panitumumab IRDye800 as an Optical Imaging Agent to Detect Pediatric Neoplasms During Neurosurgical Procedures
In Brief
A Phase 2 clinical trial evaluating Panitumumab-IRDye800, Pinpoint-IR9000 endoscopic/handheld device, and 2 other interventions for Brain Tumor. Currently recruiting, targeting 12 participants across 1 site.
Detailed Summary
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Study Details
Timeline
Interventions
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).