Actively Recruiting
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
Led by Lumicell, Inc. · Updated on 2026-01-16
66
Participants Needed
1
Research Sites
556 weeks
Total Duration
On this page
Sponsors
L
Lumicell, Inc.
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of esophageal, colorectal, or pancreatic adenocarcinoma confirmed by biopsy before surgery
- Scheduled for surgical removal of the primary tumor, including endoscopic mucosal resection
- Age 18 years or older
- Able and willing to follow study procedures
- Signed informed consent form
- Healthy enough to undergo surgery or endoscopic procedure
- Normal organ and marrow function as defined by specific blood counts and liver and kidney tests
- Women of child-bearing potential agree to use effective contraception during study and for 60 days after imaging agent injection
- ECOG performance status of 0 or 1
- Previous pre-operative radiation or chemotherapy allowed
You will not qualify if you...
- Use of an investigational drug within 30 days before enrollment
- QTc interval greater than 480 ms
- Not recovered from adverse events caused by drugs or diagnostic agents more than 4 weeks earlier
- Uncontrolled hypertension with systolic blood pressure over 180 mm Hg or diastolic over 110 mm Hg
- History of allergic reaction to drugs containing polyethylene glycol (PEG)
- History of allergic reaction to oral or intravenous contrast agents
- Pregnant or breastfeeding women
- Sexually active individuals unwilling or unable to use medically acceptable contraception
- HIV-positive individuals on combination antiretroviral therapy
- Any condition that the investigator feels makes participation unsafe or not in the participant's best interest
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
J
Jorge Ferrer, Ph.D
CONTACT
K
Kate Smith, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
6
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