Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

Not Recruiting

Trial ID: NCT04085887


The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.

Official Title

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

Stanford Investigator(s)


Inclusion Criteria:

   - 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

   - Life expectancy of more than 12 weeks

Exclusion Criteria:

   - Received an investigational drug within 30 days prior to first dose of Panitumumab

   - 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

   - Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in children 1 8
   years or 8 to 18 year old males or greater than 460 ms in infants up to 1 year or 8 to
   18 year old females)

   - Magnesium, potassium and calcium < the lower limit of normal per institution normal
   lab values

   - Serum creatinine > 1.5 times upper reference range

   - Other lab values that in the opinion of the primary surgeon would prevent surgical

   - Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide,
   amiodarone, sotalol) antiarrhythmic agents.

   - Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis

   - Subjects not deemed to be appropriate candidates for optimal resection of tumor based
   on location, involvement of eloquent brain, satellite lesions, or other factors not
   specifically listed here


drug: Panitumumab-IRDye800

device: Pinpoint-IR9000 endoscopic/handheld device

device: Explorer Air camera

device: PDE-NEO-II

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Vyviann Ngo