Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
ConditionBrain Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-25
SponsorStanford University
About this trial
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Eligibility criteria
Qualifiers
Subjects with suspected brain tumors 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 felt to be candidates for resection.
Subjects must be eligible for resection as determined by the operating surgeon.
Planned standard of care surgery
Subject age 6 months to 25 years
Disqualifiers
Received an investigational drug within 30 days prior to first dose of Panitumumab IRDye800
Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
History of infusion reactions to monoclonal antibody therapies
Pregnant or breastfeeding
Trial design
Treatments tested in this trial
- Panitumumab-IRDye800
- Pinpoint-IR9000 endoscopic/handheld device
- Explorer Air camera
- PDE-NEO-II
Treatment groups
12 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov