Recruiting
Phase 1
Phase 2

Panitumumab-IRDye800

Sponsor:

Stanford University

Code:

NCT03510208

Conditions

Malignant Brain Neoplasm

Malignant Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Near-Infrared Fluorescence Imaging

Panitumumab

Panitumumab-IRDye800

POINPOINT-IR9000

Study Details

Brief 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

Study ID

NCT03510208

Start date

May 16, 2018

Status verified date

Jun, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 to and capable of providing informed consent and willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria:

1. Received an investigational drug within 30 days prior to first dose of Panitumumab-IRDye800.
2. Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease as determined by PI; or unstable angina within 6 months prior to enrollment.
3. History of infusion reactions to monoclonal antibody therapies
4. Pregnant or breastfeeding.
5. Evidence of QTc prolongation on pretreatment ECG (greater than 440 ms in males or greater than 460 ms in females).
6. Any of the following lab values:

1. Platelet count < 75,000/mm3
2. TSH ≥ 13 micro International Units/mL.
3. Magnesium, potassium, or calcium < each respective upper limit of normal
4. Serum creatinine > 1.5 times upper limit of normal
7. Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
8. Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
9. Participants not deemed by PI 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

46 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Cohort 1 -50mg panitumumab-IRDye800

A panitumumab-IRDye800 dose of 50mg (Cohort 1) with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery. Participants then undergo NIR imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.

experimental: Cohort 2 -100mg panitumumab-IRDye800

A panitumumab-IRDye800 dose of 100mg (Cohort 2) with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery. Participants then undergo NIR imaging during standard of care surgery 1-5 days after receiving panitumumab-IRDye800.

experimental: Cohort 3 -100mg panitumumab-IRDye800

Cohort 3 dose will be determined based on Cohort 1 and Cohort 2, with or without a 100 mg loading dose of unlabeled panitumumab will be injected 1 to 5 days before the planed standard of care surgery

experimental: Cohort 4

Cohort 4 will enroll 24 participants with vestibular schwannomas at the optimal dose of 100mg, as determined by the research team based on data analysis from the first two cohorts.

Interventions

Near-Infrared Fluorescence Imaging

Undergo NIR imaging

Panitumumab

Given IV

Panitumumab-IRDye800

Given IV

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").

Primary outcome measure

  • 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, graded according to Common Terminology Criteria for Adverse Effects (CTCAE) v. 4.0 [ Time Frame: Up to 30 days ]

Central Contacts and Locations

Central contacts

Sandra Torres

(650) 723-5281sandraet@stanford.edu

Locations

Stanford University School of Medicine

Recruiting

Palo Alto, California, United States, 94304

Contacts

Sandra Torres

650-723-5281sandraet@stanford.edu

Principal Investigator:

Lindsay Moore, MD

More Information

Sponsor

Stanford University

Last update posted

Jun 29, 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 2026-06-29.