Study on Using Panitumumab-IRDye800 to Detect Lung Cancer During Surgery

Sponsor: Eben Rosenthal

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03582124

Provider View

This clinical trial is testing a new method to help surgeons see lung cancer more clearly during surgery using a special dye combined with a drug called panitumumab. The study aims to find the best dose and timing for this combination to make cancer cells more visible.

Patient Parameters

Program Overview

This study is exploring the use of a new imaging agent, panitumumab-IRDye800, to help detect lung cancer during surgery. Panitumumab is a drug that targets cancer cells, and IRDye800 is a special dye that can be seen with a camera. Together, they may help surgeons see cancer cells more clearly compared to normal tissue. The study will determine the best dose and timing for using this combination and will also assess its safety and effectiveness in making cancer cells visible during surgery.

Description

The main goal of this study is to find the best dose and timing for using panitumumab-IRDye800 to identify lung cancer during surgery. Researchers will compare how well the cancer stands out from normal tissue using this method. They will also check if this imaging agent is safe for patients undergoing lung cancer surgery.

In this study, participants will receive an infusion of panitumumab-IRDye800 through an IV over 60 minutes. This will happen on the first day of the study. After receiving the infusion, participants will undergo surgery within 1 to 5 days, during which the special dye will help surgeons see the cancer more clearly using near-infrared (NIR) imaging.

After the treatment, participants will be monitored for up to 30 days to ensure their safety and to evaluate the effectiveness of the imaging agent.

Eligibility Criteria

Inclusion Criteria

  • Have a lung nodule or mass that may be cancerous, whether or not confirmed by biopsy.
  • Scheduled for surgery to remove a lung nodule or mass for diagnosis or treatment of lung cancer.
  • Have a performance status that allows for daily activities with some effort.
  • Hemoglobin level of at least 9 gm/dL.
  • White blood cell count greater than 3000/mm³.
  • Platelet count of at least 100,000/mm³.
  • Serum creatinine level no more than 1.5 times the normal upper limit.

Exclusion Criteria

  • Have taken an investigational 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 low magnesium or potassium levels.
  • Are taking certain heart rhythm medications.
  • Have a history of lung conditions like interstitial pneumonitis or pulmonary fibrosis.
  • Are prisoners, institutionalized, or unable to give consent.

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