Study on Using Panitumumab-IRDye800 to Detect Brain Tumors in Children During Surgery

Sponsor: Stanford University

Sponsor score: 40

ClinicalTrials ID:NCT04085887

Provider View

This clinical trial is testing the safety of a special dye, Panitumumab-IRDye800, in children undergoing brain surgery to remove suspected tumors. The study also aims to find the best dose and see if the dye helps identify remaining tumor tissue during surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety of using Panitumumab-IRDye800, a special dye, in children who are having brain surgery to remove suspected tumors. The study will also determine the best dose of the dye and check if it helps surgeons see any remaining tumor tissue during the operation.

Description

In this study, children who are having brain surgery to remove suspected tumors will receive an infusion of Panitumumab-IRDye800, a special dye, 1 to 5 days before their surgery. The dye is designed to help surgeons see the tumor more clearly during the operation. During the surgery, special imaging devices will be used to visualize the tumor and any remaining cancerous tissue. After the tumor is removed, the tissue will be examined using imaging devices that do not damage the tissue. These devices help ensure that all cancerous tissue is identified and removed. The children will be monitored for 30 days after receiving the dye, with follow-up visits on the day of surgery, and on days 15 and 30 after surgery.

Eligibility Criteria

Inclusion Criteria

  • Children and young adults aged 6 months to 25 years with suspected brain tumors who are scheduled for surgical removal as part of their standard care.
  • Patients who have had chemotherapy, radiation, or a biopsy and are considered suitable for surgery by their surgeon.
  • Surgery must be part of the patient's planned standard care.
  • Patients must have a life expectancy of more than 12 weeks.

Exclusion Criteria

  • Have taken an experimental drug within 30 days before receiving Panitumumab-IRDye800.
  • Have had a heart attack, stroke, severe heart failure, significant liver disease, or unstable chest pain within 6 months before joining the study.
  • Have a history of allergic reactions to similar treatments.
  • Are pregnant or breastfeeding.
  • Have certain heart rhythm issues as shown on an ECG test.
  • Have low levels of magnesium, potassium, or calcium in the blood.
  • Have high levels of creatinine in the blood, indicating kidney issues.
  • Have other lab results that the surgeon believes would make surgery unsafe.
  • Are taking certain heart medications.
  • Have a history of lung diseases like pneumonitis or pulmonary fibrosis.
  • Are not suitable for surgery due to the tumor's location or other factors.

Locations

FACILITYZIPCITYSTATE
Stanford Cancer Center94304StanfordCalifornia

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.