Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
NCT03510208 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2026-02-09
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.
Conditions
- Malignant Brain Neoplasm
- Malignant Glioma
Interventions
- PROCEDURE
-
Near-Infrared Fluorescence Imaging
Undergo NIR imaging
- BIOLOGICAL
-
Panitumumab
Given IV
- DRUG
-
Panitumumab-IRDye800
Given IV
- DEVICE
-
POINPOINT-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").
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Gordon Li, MD · Stanford University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-16
- Primary Completion
- 2026-05-31
- Completion
- 2026-05-31
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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