Phase I/II, Open-Label Study Evaluating the Efficacy and Pharmacokinetics of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Neoplasms During Neurosurgical Procedures
Stanford University
Summary
The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery. Panitumumab-IRDye800 can attach to tumor cells and make them more visible using a special camera during surgery, which may help surgeons better distinguish tumor cells from normal brain tissue and identify small tumors that cannot be seen using current imaging methods.
Description
PRIMARY OBJECTIVES: I. Determine/verify the safety and pharmacokinetic profile of panitumumab conjugated to the optical dye IRDye800CW (panitumumab-IRDye800), as an imaging agent in patients undergoing surgery for malignant glioma. SECONDARY OBJECTIVES: I. Determine the efficacy of panitumumab IRDye800 in identifying malignant glioma compared to surrounding normal central nervous system tissue. II. Determine whether a loading dose of panitumumab is necessary to achieve an effective tumor-to-background ratio. III. Determine the optimal timing of the surgical procedure to maximize the tumor…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1\) One of the following: 1. Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma 2. Cohort 4: Participants with suspected or confirmed diagnosis of vestibular schwannoma 2.) Planned surgical removal of the tumor as part of standard of care. This may include participants postchemotherapy, post-radiation, and/or participants who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection. 3\) Participant age ≥ 18 years. 4\) Participants or their designated advocates must be willing…
Interventions
- ProcedureNear-Infrared Fluorescence Imaging
Undergo NIR imaging
- BiologicalPanitumumab
Given IV
- DrugPanitumumab-IRDye800
Given IV
- DevicePOINPOINT-IR9000
Intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during surgery and/or on ex-vivo resected tissues in the surgery suite ("back table").
Location
- Stanford University School of MedicinePalo Alto, California