A Phase 1/2 interventional study of Panitumumab-IRDye800 and Pinpoint-IR9000 endoscopic/handheld device in Brain Tumor, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 6 Months to 25 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Stanford University · Phase 1/2, Interventional, and Diagnostic
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Among 12 studies in Brain Neoplasms by Stanford University — 4 open to participants now, 4 under way, none of them phase 3. Brain Neoplasms · Stanford University.
Among the 12 studies in Brain Neoplasms by Stanford University, this one is the 8th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2026, is one of 3 in phase 1/2, and was the 9th registered.
2,441 studies on the registry are indexed under Brain Neoplasms; 541 are open to participants now.
Browse Brain Neoplasms studies →4 of the 12 studies in Brain Neoplasms by Stanford University are open now, in 1 country. Recruiting first, the newest first:
Stanford University · Sites in United States
Ages 1–30
Stanford University · Sites in United States
Ages 18+
Stanford University · Sites in United States
Ages 18+
By country, each count listing its studies:
Of the 424 Brain Neoplasms studies recruiting now, 285 (67%) set no upper age limit and 82 (19%) stop at 75 or younger; 80 take children under 18; 36 take healthy volunteers.
This study: 6 Months to 25 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 5
First in 2002; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 12 is below the median of 40 across 1,832 interventional studies indexed under Brain Neoplasms.
Median enrollment 20 across the 10 interventional studies, 169 across the 2 observational. Of the 7 that completed or were terminated, 3 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
Stanford University is the lead sponsor of 2,169 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
3 of the studies in Brain Neoplasms by Stanford University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03510208Stanford UniversityPanitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery | 2026-11 |
| NCT06712927Stanford UniversityTrial of Relatlimab, Nivolumab, and Ipilimumab in Patients With Asymptomatic and Symptomatic Melanoma Brain Metastases | 2026-11 |
| NCT07087002Stanford UniversityGPC2-CAR T Cell Therapy for Relapsed or Refractory Medulloblastoma in Children and Young Adults | 2027-08 |
Add all 3 to your calendar (.ics) → With an account.
Among the 12 studies in Brain Neoplasms by Stanford University, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Primary objective: is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
Secondary Objective:
Pediatric subjects will undergo standard of care, histopathologically-based, surgical resection of tumor 1 to 5 days after infusion of Panitumumab-IRDye800. Intraoperative imaging will be performed using an intraoperative optical imaging devices and wide-field imaging devices.
Back table imaging of the resection tissue (ex vivo) will be also performed with the wide-field device. Ex vivo imaging of the specimens prior to and during pathological assessment will be performed using the non-invasive, close field imaging device that does not violate or destroy the tissue. Additional imaging devices used solely on the back table are not included in this record, as the data is collected is not used for medical decisions and such devices are therefore not interventions.
Pediatric subjects will be followed for 30 days following their study infusion with scheduled follow up visits on the day of surgery (Day 1 5), Day 15, and Day 30.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose: 0.006 Panitumumab-IRDye800 (mg/kg)
Drug: Panitumumab-IRDye800 · Device: Pinpoint-IR9000 endoscopic/handheld device · Device: Explorer Air camera · Device: PDE-NEO-II
Dose: 0.25 Panitumumab-IRDye800 (mg/kg)
Drug: Panitumumab-IRDye800 · Device: Pinpoint-IR9000 endoscopic/handheld device · Device: Explorer Air camera · Device: PDE-NEO-II
Dose: 0.50 Panitumumab-IRDye800 (mg/kg)
Drug: Panitumumab-IRDye800 · Device: Pinpoint-IR9000 endoscopic/handheld device · Device: Explorer Air camera · Device: PDE-NEO-II
Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)
Drug: Panitumumab-IRDye800 · Device: Pinpoint-IR9000 endoscopic/handheld device · Device: Explorer Air camera · Device: PDE-NEO-II
Drug pages: Panitumumab · IRDye800
Panitumumab-IRDye800 is an imaging agent prepared as a drug-dye compound from panitumumab (Vectibix), a fully-humanized IgG2 monoclonal anti-epidermal growth factor receptor (EGFR) antibody, and IRDye800CW dye. Panitumumab-IRDye800 delivered intravenous (IV).
Novadaq intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).
Surgvision intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).
Hamamatsu Photonics KK intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).
Toxicities (related adverse events)
Adverse events related to the agent or procedure are considered toxicities, and is assessed as the 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 or procedure. The outcome is reported by dose treatment group (cohort) as a number without dispersion.
Time frame: 30 days
Panitumumab-IRDye800 Fluorescence Intensity
Dosing of panitumumab-IRDye800 in the study participants will be assessed on the basis of fluorescence intensity, determined as the ratio of fluorescence intensity in tumor tissue to that of normal tissue. This is known as the tumor-to-background ratio (TBR). The outcome will be reported by dose treatment group (cohort) as the mean TBR with standard deviation.
Time frame: 5 days
Tumor-to-background Ratio (TBR) Sensitivity and Specificity for Optimal Dose Level
The merit of Panitumumab-IRDye800 to identify pediatric tumors during surgery will be assessed as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (PPV), based on the actual histopathological diagnosis for the excised lesions. * Sensitivity is the "true positive rate" (by histopathology), expressed as a proportion (ratio) * Specificity is the "true negative rate," expressed as a proportion * Positive predictive value (PPV) is the proportion of tumor-positive samples that were actually cancer; * Negative predictive value (NPV) is the proportion of tumor-negative samples that were not cancer. Per protocol, the analysis is only conducted for those participants who were treated with the optimal dose level. Higher values indicate greater merit. The outcome will be reported per protocol for the optimal dose level as the sensitivity; specificity; PPV; and NPV, with 95% confidence interval.
Time frame: 7 days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
Of 49 non-industry phase 1/2 interventional studies under Brain Neoplasms, half reached primary completion within 82 months of starting (the median), counting those still running; a quarter within 48 and three quarters within 102. This study's planned 24 months is below that.
Counting every sponsor, half of 71 studies reached it within 82 months; a quarter within 48 and three quarters within 105.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Dec 2026, on Sep 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Panitumumab · IRDye800