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New treatment option for Meningioma
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?
Panitumumab-IRDye800 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for meningioma.
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
- 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.
- 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. These may include people status post...
- Subject age ≥ 18 years.
- Adequate hematologic and end-organ function appropriate for surgery and panitumumab infusion as determined by routine preoperative evaluation or...
- Chemistry Panel - Potassium, BUN (or urea), and Creatinine
- CBC with differential - WBC, including ANC, hemoglobin, hematocrit, and platelet count
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. These may include people status post chemotherapy and/or radiation or people who have undergone diagnostic biopsy...
- 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...
- 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's taking place
- 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 - 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?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.