Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEben Rosenthal

About this trial

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.

Eligibility criteria

Qualifiers

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.

Chemistry Panel - Potassium, BUN (or urea), and Creatinine

CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Panitumumab-IRDye800

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Eben Rosenthal

Lead sponsor

Vanderbilt-Ingram Cancer Center

Sponsor institution