An Early Phase 1 interventional study of Panitumumab-IRDye800 in Meningioma, Glioblastoma and Acoustic Neuroma, sponsored by Eben Rosenthal. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Eben Rosenthal · Early Phase 1, Interventional, and Supportive care
This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.
This study will evaluate a single intravenous dose of panitumumab-IRDye800 (pan800) in subjects with intracranial lesions who are scheduled to undergo standard-of-care neurosurgical resection. The study drug will be administered 1-5 days prior to surgery, after which participants will undergo their planned procedure with intraoperative near-infrared fluorescence imaging to assess tumor visualization. Following the infusion, subjects will be monitored for immediate adverse events, and a member of the study team will continue safety follow-up through postoperative assessments and a Day 15 follow-up contact. Participants will otherwise continue to receive standard-of-care evaluation and treatment for their intracranial disease at the discretion of their treating physicians.
255 studies on the registry are indexed under Meningioma; 85 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 180 interventional studies indexed under Meningioma.
Browse Meningioma studies →Eben Rosenthal is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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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.
Adequate hematologic and end-organ function appropriate for surgery and panitumumab infusion as determined by routine preoperative evaluation or designee prior to infusion. If liver function, renal function, and hematologic laboratory test results are acceptable for elective surgery and panitumumab infusion, the patient is considered eligible for the study. Laboratory results will need to be obtained within 30 days prior to initiation of study treatment include:
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 protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
Participants will receive a single 50 mg IV dose of panitumumab-IRDye800 (pan800) 1-5 days before standard-of-care neurosurgical resection. Participants will undergo immediate post-infusion monitoring, postoperative pharmacokinetic blood draws, and adverse-event assessments through surgery and a Day 15 (±7) follow-up.
Drug: Panitumumab-IRDye800
Participants will receive a single 100 mg IV dose of panitumumab-IRDye800 (pan800) 1-5 days before their standard-of-care neurosurgical resection. Participants will undergo immediate post-infusion monitoring along with postoperative pharmacokinetic and immunogenicity blood sampling and adverse-event assessments through surgery and the Day 15 (±7) follow-up visit.
Drug: Panitumumab-IRDye800
Drug pages: Panitumumab · IRDye800
Subjects receive a single infusion of panitumumab-IRDye800 (pan800) and will undergo near-infrared fluorescence imaging during their neurosurgical procedure 1-5 days after the infusion.
Determine the safety of panitumumab-IRDye800 as an imaging agent in patients undergoing surgery for intracranial lesions.
Safety will be defined by the number of Grade ≥ 2 AEs determined that are clinically significant and considered definitely or probably related to pan800. Safety data will be summarized by grade, severity, and type.
Time frame: From infusion to 15 days post-infusion.
Determine the efficacy of panitumumab-IRDye800 in identifying intracranial lesions compared to surrounding normal central nervous system tissue.
Efficacy will be measured by tumor-to-background ratio (TBR) using fluorescence intensity measurements.
Time frame: Within 14 days post-surgery
Determine the dosage of the study drug infusion to maximize the tumor-to- background ratio.
There will be an assessment of tumor-to-background ratio (TBR) comparing cohort 1 \& 2.
Time frame: Within 14 days post-surgery
Determine the optimal timing of the study drug infusion to maximize the tumor-to- background ratio.
There will be an assessment of tumor-to-background ratio (TBR). Some patients may receive the study drug on varying pre-surgery days rather than infusions on the same day for every patient. The TBR will be assessed for every patient regardless of pre-surgery infusion day. The optimal timing of administration of the study drug will be determined by the highest average TBR from a particular pre-surgery infusion day. TBR will still be assessed using the intraoperative fluorescence imaging taken on the standard of care surgery.
Time frame: Within 14 days post-surgery
Plan to share: Undecided — We do not plan to share individual participant data from this phase 1 study due to its exploratory nature with a study drug. Sharing individual-level data at this stage could compromise participant confidentiality and may not yield meaningful insights given the preliminary scope of the study. Additionally, the data collected may not meet the robustness or generalizability standards required for broader dissemination. The investigators do not plan to share IPD with other researchers at this time.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for May 2030, 46 months after the start.
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
Eben Rosenthal