Panitumumab-IRDye800 for guiding brain tumor surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study tests a fluorescent imaging agent, panitumumab-IRDye800, given as a single IV dose 1–5 days before brain tumor surgery. During surgery, researchers use near-infrared fluorescence to help distinguish tumor tissue from normal brain. Safety is monitored after infusion and through postoperative follow-up, while patients continue standard care for their intracranial lesions.

Why it matters

Who can join: the full rules

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

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Peter Morone, MD — Vanderbilt University Medical Center
• Study coordinator: Makenna Brown
• Email: makenna.l.brown@vumc.org
• Phone: 615-421-4370

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.