Panitumumab-IRDye800 Glowing Dye to Help Spot Brain Tumors During Surgery
Tests panitumumab-IRDye800 as a surgical imaging dye in adults having brain lesions removed.
Key facts
- Who runs it
- Eben Rosenthal
- Where
- Nashville, United StatesSee the site
- Trial code
- Registry title
- Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 30 people, planned
- Started
- 7 Jul 2026
- Expected to end
- Jun 2031
- Type of study
- Interventional, 2 groups
- Treatments tested
- Panitumumab-IRDye800
- Record updated
- 16 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who are having an intracranial (inside the skull) lesion removed by surgery as part of their usual care. They receive an imaging agent called panitumumab-IRDye800 to help see the lesion during surgery.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- An intracranial lesion that is being removed by surgery as standard care. This can include people who had chemotherapy or radiation before, or a biopsy to diagnose the lesion.
- Earlier treatment
- Earlier chemotherapy, radiation or a diagnostic biopsy is allowed. People who had a reaction to an infusion of any monoclonal antibody therapy cannot join.
Main reasons for not taking part
- Heart attack, stroke or uncontrolled chronic heart failure in the last 6 months
- Earlier reaction to an infusion of any monoclonal antibody therapy
- Currently pregnant or breastfeeding
- QTcF heart rhythm interval above 480 milliseconds
- History or signs of interstitial pneumonitis or pulmonary fibrosis
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Subjects with intracranial lesions undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are deemed to be candidates for resection
- Subject age ≥ 18 years
- 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:; Chemistry Panel - Potassium, BUN (or urea), and Creatinine; CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count; Magnesium and Phosphorus
- Women of childbearing potential must have a negative pregnancy test within 7 days of study drug administration
- Ability to understand and willingness to sign a written informed document or written informed consent via a surrogate consent rider from the patients' healthcare decision maker
Who cannot take part
- Had a myocardial infarction, cerebrovascular accident, or uncontrolled chronic heart failure within 6 months prior to enrollment
- Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- History of infusion reactions to any monoclonal antibody therapies
- Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- Patients with severe renal disease or anuria
- Magnesium or phosphorus lower than normal institutional values, and subject is symptomatic
- Women who are currently pregnant or breastfeeding
- Participants presenting with a baseline QTcF interval > than 480 milliseconds
Where in United States
- Vanderbilt University Medical CenterNashville, United StatesContact: Makenna BrownTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Study Arm - 50 mg pan800Treatment being tested
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.
Treatment: Panitumumab-IRDye800
- Study Arm - 100 mg pan800Treatment being tested
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.
Treatment: Panitumumab-IRDye800
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
- Plain-language title
- Panitumumab-IRDye800 Glowing Dye to Help Spot Brain Tumors During SurgeryGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 16 October 2026