๐ฌIn plain words
What the trial is, and whether it could suit you
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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 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
* 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 resection
* 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
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What it tests
- Panitumumab-IRDye800
- Pinpoint-IR9000 endoscopic/handheld device
- Explorer Air camera
- PDE-NEO-II
Stanford Cancer Center
Stanford, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.