NCT07493447 Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
| NCT ID | NCT07493447 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Eben Rosenthal |
| Condition | Meningioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-07 |
| Primary Completion | 2030-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-07 with a primary completion date of 2030-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Peter Morone, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT07493447 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Meningioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07493447 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07493447 currently recruiting?
Yes, NCT07493447 is actively recruiting participants. Contact the research team at makenna.l.brown@vumc.org for enrollment information.
Where is the NCT07493447 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT07493447 clinical trial?
NCT07493447 is sponsored by Eben Rosenthal. The principal investigator is Peter Morone, MD at Vanderbilt University Medical Center. The trial plans to enroll 30 participants.