NCT04085887RecruitingPhase 1/2
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
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
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 9 Sept 2019
- Start date
- Dec 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Stanford University
- Diseases
- Childhood cancers
- NCT number
- NCT04085887
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 12
- From Dec 2026 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- 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
Other illness
- History of infusion reactions to monoclonal antibody therapies
- Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
Lab values
- 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
Other
- Pregnant or breastfeeding
Who the study is looking for
- 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
Age in the registry: 6 months to 25 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford Cancer Center Coordinator of this site? Confirm its status | Stanford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.