Recruiting
Phase 1
Phase 2

Panitumumab-IRDye800

Sponsor:

Stanford University

Code:

NCT04085887

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

Interventions

Panitumumab-IRDye800

Pinpoint-IR9000 endoscopic/handheld device

Explorer Air camera

PDE-NEO-II

Study Details

Brief summary:

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

Conditions

Brain Tumor

Study ID

NCT04085887

Start date

Aug, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort 1-0.006 Panitumumab-IRDye800

Dose: 0.006 Panitumumab-IRDye800 (mg/kg)

experimental: Cohort 2-0.25 Panitumumab-IRDye800

Dose: 0.25 Panitumumab-IRDye800 (mg/kg)

experimental: Cohort 3-0.50 Panitumumab-IRDye800

Dose: 0.50 Panitumumab-IRDye800 (mg/kg)

experimental: Cohort 4-1.0 Panitumumab-IRDye800

Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)

Interventions

Panitumumab-IRDye800

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).

Pinpoint-IR9000 endoscopic/handheld device

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).

Explorer Air camera

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).

PDE-NEO-II

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).

Primary outcome measure

  • Toxicities (related adverse events) [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Nancy Sweeters

650-721-4074nks2016@stanford.edu

Locations

Stanford Cancer Center

Recruiting

Stanford, California, United States, 94304

Contacts

Nancy Sweeters

650-721-4074nks2016@stanford.edu

Principal Investigator:

Laura Prolo, MD

More Information

Sponsor

Stanford University

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-06-30.