Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jul 2026
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 25, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
June 30, 2026
June 1, 2026
3.8 years
February 25, 2026
June 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From infusion to 15 days post-infusion.
Secondary Outcomes (3)
Determine the efficacy of panitumumab-IRDye800 in identifying intracranial lesions compared to surrounding normal central nervous system tissue.
Within 14 days post-surgery
Determine the dosage of the study drug infusion to maximize the tumor-to- background ratio.
Within 14 days post-surgery
Determine the optimal timing of the study drug infusion to maximize the tumor-to- background ratio.
Within 14 days post-surgery
Study Arms (2)
Study Arm - 50 mg pan800
EXPERIMENTALParticipants 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.
Study Arm - 100 mg pan800
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Had a myocardial infarction, cerebrovascular accident, or uncontrolled chronic heart failure within 6 months prior to enrollment.
- History of infusion reactions to any monoclonal antibody therapies.
- Women who are currently pregnant or breastfeeding.
- Participants presenting with a baseline QTcF interval \> than 480 milliseconds.
- Magnesium or phosphorus lower than normal institutional values, and subject is symptomatic.
- Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- Patients with severe renal disease or anuria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eben Rosenthallead
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-0004, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Morone, MD
Vanderbilt University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Barry and Amy Baker Professor and Chair
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 25, 2026
Study Start
July 1, 2026
Primary Completion (Estimated)
May 1, 2030
Study Completion (Estimated)
June 1, 2031
Last Updated
June 30, 2026
Record last verified: 2026-06