Study on the Feasibility of Using the LUM Imaging System to Detect Gastrointestinal Cancers

Sponsor: Lumicell, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02584244

Provider View

This study is testing a new imaging system called LUM to see if it can safely and effectively help detect colorectal, pancreatic, and esophageal cancers during surgery. The study involves using a special imaging agent, LUM015, to highlight cancerous tissues.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new imaging agent, LUM015, which is given through an IV before surgery to help detect colorectal, pancreatic, and esophageal cancers. The LUM Imaging System is used to see if it can identify cancerous tissues during surgery. Patients with these types of cancers who are scheduled for surgery will receive the imaging agent before their procedure. The study will monitor patients for any side effects and assess how well the imaging system works in identifying cancerous tissues.

Description

This study is exploring a new method to help surgeons detect cancerous tissues during surgery for colorectal, pancreatic, and esophageal cancers. The method involves using an imaging agent called LUM015, which is given through an IV before surgery. This agent helps highlight cancerous tissues when viewed with the LUM Imaging System.

Patients participating in the study will have already been diagnosed with one of these cancers and will be scheduled for surgery to remove their tumors. Before surgery, patients will have a routine check-up and necessary tests to ensure they are eligible for the study. On the day of surgery, LUM015 will be administered a few hours before the procedure. The timing of the injection varies slightly depending on the type of cancer being treated.

During surgery, the removed tissues will be examined using the LUM Imaging System to see if the imaging agent helps identify cancerous areas. These tissues will also undergo standard pathology tests to confirm the presence of cancer. Patients will be monitored for any side effects from the imaging agent while they are in the hospital and during their first follow-up visit after surgery.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of colorectal, pancreatic, or esophageal cancer and be scheduled for surgery to remove the tumor.
  • Can be at any stage of cancer.
  • May have received radiation or chemotherapy before surgery.
  • Must be 18 years or older.
  • Must be willing to follow study procedures and instructions.
  • Must sign an informed consent form.
  • Must be healthy enough to undergo surgery or an endoscopic procedure.
  • Must have normal blood and organ function as determined by specific tests.
  • Women of childbearing age must agree to use effective birth control during the study and for 60 days after receiving the imaging agent.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Have taken an investigational drug within 30 days before joining the study.
  • Have a heart rhythm issue with a QTc interval greater than 480ms.
  • Have not recovered from side effects of previous treatments given more than 4 weeks ago.
  • Have uncontrolled high blood pressure.
  • Have a history of allergic reactions to drugs containing polyethylene glycol (PEG) or contrast agents.
  • Are pregnant or breastfeeding.
  • Are sexually active and not willing to use effective birth control.
  • Are HIV-positive and on antiretroviral therapy.
  • Any other reason the investigator believes participation is not in the best interest of the patient.

Get This Program In Your Inbox

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