Study on Panitumumab-IRDye800 for Diagnosing Malignant Brain Tumors During Surgery

Sponsor: Eben Rosenthal

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03510208

Provider View

This clinical trial is testing a new method using Panitumumab-IRDye800 to help surgeons see malignant brain tumors more clearly during surgery. The study aims to find the best dose and check for any side effects.

Patient Parameters

Program Overview

This study is exploring the use of Panitumumab-IRDye800, a special imaging agent, to help surgeons better identify malignant brain tumors during surgery. The agent attaches to tumor cells, making them glow under a special camera, which may help distinguish tumor cells from normal brain tissue and detect small tumors that are hard to see with current imaging techniques. The trial is in two phases: Phase I focuses on finding the safest dose, and Phase II evaluates how well the agent works in identifying tumors.

Description

The main goal of this study is to ensure the safety of Panitumumab-IRDye800 and understand how it behaves in the body when used as an imaging tool during brain tumor surgery. Researchers also want to see how effective it is in helping surgeons identify malignant brain tumors compared to normal brain tissue. They are investigating whether an initial dose of Panitumumab is needed to achieve the best contrast between tumor and normal tissue and determining the best timing for surgery to maximize this contrast. The study is conducted in two parts: an initial phase to find the safest dose, followed by a second phase to test its effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Patients with suspected brain tumors who are scheduled for surgical removal as part of their standard treatment.
  • Patients who have had chemotherapy, radiation, or a biopsy and are considered suitable for surgery.
  • Must have a platelet count of at least 75,000/mm³.

Exclusion Criteria

  • Have taken an experimental drug within 30 days before the first dose of Panitumumab-IRDye800.
  • Have had a heart attack, stroke, uncontrolled heart failure, significant liver disease, or unstable chest pain within the last 6 months.
  • Have a history of allergic reactions to monoclonal antibody treatments.
  • Are pregnant or breastfeeding.
  • Have an abnormal heart rhythm as shown on an ECG.
  • Have high thyroid-stimulating hormone levels.
  • Have low magnesium, potassium, or calcium levels.
  • Have other lab results that would prevent safe surgery, as determined by the surgeon.
  • Are taking certain heart rhythm medications.
  • Have a history of lung diseases like interstitial pneumonitis or pulmonary fibrosis.
  • Are not suitable candidates for optimal tumor removal based on tumor location or other factors.

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