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

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.

Interventions

• Panitumumab-IRDye800 · DRUG

  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.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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:

  1. Chemistry Panel - Potassium, BUN (or urea), and Creatinine
  2. CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count
  3. 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.

Exclusion Criteria:

* 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

Sites (1)

• Vanderbilt University Medical Center, Nashville, Tennessee · RECRUITING