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
2 other identifiers
interventional
12
1 country
1
Brief Summary
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2019
CompletedFirst Posted
Study publicly available on registry
September 11, 2019
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 20, 2026
March 1, 2026
2.7 years
September 9, 2019
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Toxicities (related adverse events)
Adverse events related to the agent or procedure are considered toxicities, and is assessed as the number of Grade 2 or higher adverse events which have been determined to be clinically-significant and definitely, probably, or possibly-related to the study treatment or procedure. The outcome is reported by dose treatment group (cohort) as a number without dispersion.
30 days
Secondary Outcomes (2)
Panitumumab-IRDye800 Fluorescence Intensity
5 days
Tumor-to-background Ratio (TBR) Sensitivity and Specificity for Optimal Dose Level
7 days
Study Arms (4)
Cohort 1-0.006 Panitumumab-IRDye800
EXPERIMENTALDose: 0.006 Panitumumab-IRDye800 (mg/kg)
Cohort 2-0.25 Panitumumab-IRDye800
EXPERIMENTALDose: 0.25 Panitumumab-IRDye800 (mg/kg)
Cohort 3-0.50 Panitumumab-IRDye800
EXPERIMENTALDose: 0.50 Panitumumab-IRDye800 (mg/kg)
Cohort 4-1.0 Panitumumab-IRDye800
EXPERIMENTALDose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)
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).
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).
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).
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Cancer Center
Stanford, California, 94304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura Prolo, MD
Stanford University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2019
First Posted
September 11, 2019
Study Start
April 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share