Study on Panitumumab-IRDye800 for Patients with Pancreatic Cancer Undergoing Surgery

Sponsor: Eben Rosenthal

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03384238

Provider View

This clinical trial is testing a new imaging agent, Panitumumab-IRDye800, to see if it can help surgeons better identify pancreatic cancer cells during surgery. The study aims to find the best dose and assess the safety of this approach.

Patient Parameters

Program Overview

This study is exploring the use of Panitumumab-IRDye800, a combination of a drug and a special dye, to help surgeons see pancreatic cancer cells more clearly during surgery. The dye makes the cancer cells glow under a special camera, potentially making it easier to distinguish them from normal tissue. The trial will determine the best dose and check for any side effects in patients undergoing surgery for pancreatic cancer.

Description

The main goal of this study is to find the best dose of Panitumumab-IRDye800 that helps identify pancreatic cancer cells compared to normal tissue. Researchers will also check if the dye can help detect cancer that has spread, affected lymph nodes, or leftover cancer that isn't visible with regular light.

The study is divided into two phases. In the first phase, different doses of Panitumumab-IRDye800 will be tested to find the optimal amount. In the second phase, the focus will be on how well the dye works in surgery.

Participants will receive an initial dose of Panitumumab through an IV, followed by Panitumumab-IRDye800. Surgery will take place 2-5 days later, using special imaging systems to see the dye. After treatment, patients will have follow-up visits at 15 and 30 days to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Suspected or confirmed pancreatic cancer diagnosis.
  • Scheduled for surgery to remove pancreatic cancer with the goal of curing it.
  • Expected to live more than 12 weeks.
  • Good overall health, able to carry out normal activities with some effort.
  • Sufficient levels of hemoglobin, platelets, magnesium, potassium, and calcium in the blood.
  • Normal thyroid function as indicated by specific blood tests.

Exclusion Criteria

  • Have taken an experimental drug within 30 days before starting the study treatment.
  • Have had a heart attack, stroke, severe heart failure, or unstable chest pain in the past 6 months.
  • Have had allergic reactions to Panitumumab or similar treatments.
  • Are pregnant or breastfeeding.
  • Have certain heart rhythm issues as shown by an ECG.
  • Have lab results that suggest surgery would not be safe.
  • Are taking specific heart medications that could interfere with the study treatment.

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