Malignant Brain NeoplasmPhase 1/2NCT03510208
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
A Phase 1/2 study testing Near-Infrared Fluorescence Imaging, Panitumumab and Panitumumab-IRDye800 in people with Malignant Brain Neoplasm and Malignant Glioma, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Brain Neoplasm, Malignant Glioma
- What is being tested?
- Near-Infrared Fluorescence Imaging, Panitumumab and Panitumumab-IRDye800
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2018to Nov 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) One of the following:
- Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma
- 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.
Who cannot join
- 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 as determined by PI; 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 males or greater than 460 ms in females).
- Any of the following lab values:
Show all 13Show fewer
- Platelet count < 75,000/mm3
- TSH ≥ 13 micro International Units/mL.
- Magnesium, potassium, or calcium < each respective upper limit of normal
- Serum creatinine > 1.5 times upper limit of normal
- Participants receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Participants with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Palo Alto, California, 94304
Sandra Torres, 650-723-5281, sandraet@stanford.edu
Lindsay Moore, MD
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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-to-background ratio.
OUTLINE: This is a phase I, dose escalation study of panitumumab-IRDye800 followed by a phase II study.
- Conditions
- Malignant Brain Neoplasm, Malignant Glioma
- Being tested
- Near-Infrared Fluorescence Imaging, Panitumumab, Panitumumab-IRDye800, POINPOINT-IR9000
- Medical subject headings
- Brain Neoplasms, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-Infrared Fluorescence ImagingProcedure or surgery
Also called NIR Fluorescence Imaging, NIR Optical Imaging
Undergo NIR imaging
PanitumumabBiological
Also called ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, MoAb ABX-EGF
Given IV
Panitumumab-IRDye800Drug
Also called Panitumumab IRDye 800, RDye800-Panitumumab Conjugate
Given IV
POINPOINT-IR9000Device
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").
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 -50mg panitumumab-IRDye800 | Experimental | 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. Receives: Procedure: Near-Infrared Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800; Device: POINPOINT-IR9000 |
| Cohort 2 -100mg panitumumab-IRDye800 | Experimental | 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. Receives: Procedure: Near-Infrared Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800; Device: POINPOINT-IR9000 |
| Cohort 3 -100mg panitumumab-IRDye800 | Experimental | 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 Receives: Procedure: Near-Infrared Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800; Device: POINPOINT-IR9000 |
| Cohort 4 | Experimental | 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. Receives: Procedure: Near-Infrared Fluorescence Imaging; Biological: Panitumumab; Drug: Panitumumab-IRDye800; Device: POINPOINT-IR9000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Descriptive statistical analysis of subject disposition, baseline characteristics, exposure to study drug, and adverse events will be performed. Descriptive statistics for continuous data will include mean, standard deviation, median, minimum, maximum, and inter-quartile values. Frequencies and percentages will be used to summarize categorical data.
Measured: Up to 30 days
Secondary outcomes (3)
Tumor to background ratio (TBR)
TBR is defined as the fluorescence intensity of tumor tissue compared to that or normal surrounding tissue as determined by ex vivo pathological imaging. Will be analyzed with the individual specimen as the unit of analysis using the Wilcoxon signed rank test.
Measured: 30 days from study treatment
Panitumumab Loading Dose
The fluorescence intensity of tissue obtained from patients undergoing surgery will be evaluated as an indicator of whether or not the loading dose of panitumumab is necessary to achieve an effective tumor-to-background ratio (TBR). The Fluorescence intensity of tissue will be assessed on the specimens collected on the day of surgery (Day 1-5 Post infusion), in group a vs group b, for Cohorts 1 and 2, in order to determine the tumor-to-background ratio (TBR). The outcome will be expressed as TBR by group and cohort. TBR will be reported as means +/- STD.
Measured: 30 days
Optimal Timing of Surgical Procedure
The fluorescence intensity of tissue collected at surgery will be measured 1 to 5 days after infusion, and the outcome will be assessed as highest daily mean tumor-to-background ratio (TBR), with standard deviation. The tissue analysis to obtain the outcome data will occur within 1 year from surgery.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start16 May 2018
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Brain NeoplasmStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lindsay Moore, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510208
- Sponsor's protocol ID
- IRB-43179
- Other IDs
- NCI-2018-00536, BRNCNS0009, R01CA190306
- Status last verified
- Jun 2026
- First submitted
- 12 Apr 2018
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03510208
- Acronym / sponsor ID
- IRB-43179
- Conditions
- Malignant Brain Neoplasm, Malignant Glioma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 16 May 2018 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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-to-background ratio.
OUTLINE: This is a phase I, dose escalation study of panitumumab-IRDye800 followed by a phase II study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 -50mg panitumumab-IRDye800 | Experimental | Procedure: Near-Infrared Fluorescence Imaging, Biological: Panitumumab, Drug: Panitumumab-IRDye800, Device: POINPOINT-IR9000A 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. |
| Cohort 2 -100mg panitumumab-IRDye800 | Experimental | Procedure: Near-Infrared Fluorescence Imaging, Biological: Panitumumab, Drug: Panitumumab-IRDye800, Device: POINPOINT-IR9000A 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. |
| Cohort 3 -100mg panitumumab-IRDye800 | Experimental | Procedure: Near-Infrared Fluorescence Imaging, Biological: Panitumumab, Drug: Panitumumab-IRDye800, Device: POINPOINT-IR9000Cohort 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 |
| Cohort 4 | Experimental | Procedure: Near-Infrared Fluorescence Imaging, Biological: Panitumumab, Drug: Panitumumab-IRDye800, Device: POINPOINT-IR9000Cohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cohorts 1, 2, and 3: Participants with suspected or confirmed diagnosis of glioblastoma
- 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.
Key exclusion criteria (13 listed)
- 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 as determined by PI; 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 males or greater than 460 ms in females).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-Infrared Fluorescence ImagingAlso: NIR Fluorescence Imaging, NIR Optical ImagingUndergo NIR imaging | Procedure or surgery | Cohort 1 -50mg panitumumab-IRDye800, Cohort 2 -100mg panitumumab-IRDye800, Cohort 3 -100mg panitumumab-IRDye800, Cohort 4 |
| PanitumumabAlso: ABX-EGF, ABX-EGF Monoclonal Antibody, ABX-EGF, Clone E7.6.3, MoAb ABX-EGFGiven IV | Biological | Cohort 1 -50mg panitumumab-IRDye800, Cohort 2 -100mg panitumumab-IRDye800, Cohort 3 -100mg panitumumab-IRDye800, Cohort 4 |
| Panitumumab-IRDye800Also: Panitumumab IRDye 800, RDye800-Panitumumab ConjugateGiven IV | Drug | Cohort 1 -50mg panitumumab-IRDye800, Cohort 2 -100mg panitumumab-IRDye800, Cohort 3 -100mg panitumumab-IRDye800, Cohort 4 |
| POINPOINT-IR9000Intraoperative 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"). | Device | Cohort 1 -50mg panitumumab-IRDye800, Cohort 2 -100mg panitumumab-IRDye800, Cohort 3 -100mg panitumumab-IRDye800, Cohort 4 |
Primary outcome
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
Descriptive statistical analysis of subject disposition, baseline characteristics, exposure to study drug, and adverse events will be performed. Descriptive statistics for continuous data will include mean, standard deviation, median, minimum, maximum, and inter-quartile values. Frequencies and percentages will be used to summarize categorical data.
3 secondary outcomes
Tumor to background ratio (TBR)
Time frame: 30 days from study treatment
Panitumumab Loading Dose
Time frame: 30 days
Optimal Timing of Surgical Procedure
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lindsay Moore, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Near-Infrared Fluorescence Imaging, Panitumumab and Panitumumab-IRDye800 in people with Malignant Brain Neoplasm and Malignant Glioma, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Torres ((650) 723-5281, sandraet@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.