Meningioma study: Panitumumab-IRDye800
Official title Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
ClinicalTrials.gov ID: NCT07493447
What this study is testing
What is Panitumumab-IRDye800?
An investigational single‑dose intravenous imaging agent being studied for use in meningioma surgery. It is designed to bind to EGFR on tumor cells and emit near‑infrared fluorescence to help surgeons visualize the tumor during resection.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to determine whether the agent is safe to use and how well it highlights brain tumors during surgery.
- Who it's for
- Patients who have meningioma, glioblastoma, acoustic neuroma, brain cancer, or pituitary adenoma and are scheduled for surgical removal of the tumor.
- What's involved
- Participants will receive the imaging agent before surgery, and the surgeon will use special light to see the tumor during the operation.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people with intracranial lesions undergoing surgical removal as their standard of care will be eligible.
- Subject age ≥ 18 years.
- Chemistry Panel - Potassium, BUN (or urea), and Creatinine
- CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count
- Magnesium and Phosphorus
You likely can't join 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.
See the full eligibility criteria
- people with intracranial lesions undergoing surgical removal as their standard of care will be eligible.
- Subject age ≥ 18 years.
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.