RecruitingPhase 1Phase 2NCT02584244
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
Sponsor
Lumicell, Inc.
Enrollment
66 participants
Start Date
Aug 4, 2016
Study Type
INTERVENTIONAL
Conditions
Summary
The overall goal of this feasibility study is to assess the initial safety and efficacy of LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging System.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study is testing a new imaging system (the LUM Imaging System) that may help surgeons better see the edges of gastrointestinal cancers during surgery by using a special light-activated dye, potentially improving how completely tumors are removed.
**You may be eligible if...**
- You are 18 years of age or older
- You have been confirmed by biopsy to have esophageal, colorectal, or pancreatic cancer (including high-grade precancerous changes)
- You are scheduled for surgical removal of the tumor (including endoscopic procedures)
- You are in generally good health with adequate blood counts and kidney/liver function
- You are willing and able to follow study procedures and have signed the consent form
- You may have previously received pre-surgical radiation or chemotherapy
**You may NOT be eligible if...**
- You have taken an experimental drug within the past 30 days
- You are pregnant or breastfeeding
- You have uncontrolled high blood pressure
- You have a history of allergies to PEG (polyethylene glycol) or IV contrast agents
- You are HIV-positive and on antiretroviral therapy
- You are sexually active and unwilling to use contraception
- Your heart's electrical activity (QTc interval) is abnormally prolonged
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGLUM015
DEVICELUM 2.6 Imaging Device
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02584244
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