Actively Recruiting
Phase I/II Open-Label Study of Panitumumab-IRDye800 for Optical Imaging to Detect Brain Tumors During Surgery
Led by Stanford University · Updated on 2026-02-09
46
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating panitumumab-IRDye800, a special imaging agent, to help diagnose malignant glioma in patients undergoing surgery. This phase I/II trial aims to study the safety, dosing, and effectiveness of panitumumab-IRDye800 in making tumor cells more visible compared to normal brain tissue. The study also seeks to find the best timing and need for a loading dose to improve imaging results during surgery. Participants receive one of several doses of panitumumab-IRDye800, with or without an additional loading dose of unlabeled panitumumab, injected 1 to 5 days before their planned standard surgery. Near-infrared fluorescence imaging is then performed during surgery using a specialized camera to detect the dye. The trial includes multiple cohorts with escalating doses, and a specific group with vestibular schwannomas receiving the optimal dose determined by earlier results. Throughout the study, participants undergo surgical procedures with imaging to assess tumor visibility. Researchers monitor safety by tracking significant adverse events for up to 30 days after treatment. They also measure how well the imaging agent distinguishes tumor tissue from normal tissue and evaluate optimal dosing and timing over one year. The total involvement includes surgery, imaging, and follow-up assessments to understand the imaging agent's pharmacokinetics and efficacy.
CONDITIONS
Brief Title
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suspected or confirmed diagnosis of glioblastoma (Cohorts 1, 2, and 3) or vestibular schwannoma (Cohort 4)
- Planned surgical removal of the tumor as part of standard care
- Age 18 years or older
- Ability and willingness to provide informed consent and comply with study procedures
You will not qualify if you...
- Use of investigational drug within 30 days before first dose of panitumumab-IRDye800
- History of myocardial infarction, stroke, uncontrolled heart failure, significant liver disease, or unstable angina within 6 months
- History of infusion reactions to monoclonal antibody therapies
- Pregnancy or breastfeeding
- QTc prolongation on pretreatment ECG (over 440 ms in males or 460 ms in females)
- Abnormal lab values including low platelet count, high TSH, low magnesium, potassium, or calcium, or high serum creatinine
- Use of certain antiarrhythmic medications (Class IA or III)
- History or evidence of interstitial pneumonitis or pulmonary fibrosis
- Deemed inappropriate for optimal tumor resection by the principal investigator based on tumor location or other factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 to 5 days before surgery
Participants receive an intravenous injection of panitumumab-IRDye800, with or without a loading dose of panitumumab, 1 to 5 days before their planned standard of care surgery. Near-infrared fluorescence imaging is performed during surgery using an intraoperative camera.
1 to 2 visits including injection and surgery day imaging
Duration - Up to 1 year
Participants are monitored for safety and efficacy outcomes, including adverse events and tumor-to-background ratio, for up to 30 days after treatment. Additional monitoring for the optimal timing of surgical procedures may continue up to 1 year.
Follow-up visits as scheduled for up to 1 year
Trial Site Locations
Total: 1 location
1
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
S
Sandra Torres
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
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