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Feasibility Study of LUM Imaging System for Gastrointestinal Cancers

This study is testing a new way to help doctors see gastrointestinal (GI) cancers, including colorectal, pancreatic, and esophageal cancers, during surgery. It uses a drug called LUM015 and a device called LUM 2.6 Imaging Device. The goal is to see if LUM015, given before surgery, can make cancer cells glow so they are easier to spot with the imaging device. You could be eligible if you are 18 or older, have a confirmed diagnosis of esophageal, colorectal, or pancreatic adenocarcinoma (a type of cancer), and are scheduled for surgery to remove your tumor. The main goal is to see how well the glowing from LUM015 matches the actual cancer found by pathologists (doctors who study tissues) after surgery. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 66 participants. It is testing a drug (LUM015) and a device (LUM 2.6 Imaging Device).
What's involved
You would have a pre-operative visit for a physical exam and lab tests. On the day of your planned surgery, LUM015 would be given by IV injection 2-6 hours before your tumor is removed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, correlating LUM015 fluorescence with pathology results, is measured at 1 day.

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NCT02584244

Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

Recruiting
PHASE1Ages 18+InterventionalDiagnostic
Lumicell, Inc.
~66 participants
Updated 2026-01-16 on ClinicalTrials.gov
What's tested:LUM015LUM 2.6 Imaging Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Correlate LUM015 fluorescence in gastrointestinal cancers (pancreatic, esophageal, and colorectal) with pathology results
Measured over 1 day

Conditions

Colorectal Cancer
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer

Explore related trials

Colorectal CarcinomaEsophageal CarcinomaGastric CarcinomaPancreatic Carcinoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Andrew T Chan, M.D., Ph.D · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Jorge Ferrer, Ph.D
[email protected]
617-571-0592
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Leukocytes \>/= 3,000/mcL
Absolute neutrophil count \>/= 1,500/mcL
Platelets \>/= 100,000/mcL
total bilirubin within normal institutional limits (except in cases of malignant biliary obstruction)
AST (SGOT)/ALT (SGPT) \</= 2.5 X institutional upper limit of normal (\</= 5 x ULN in cases of malignant biliary obstruction)
Creatinine within normal institutional limits or creatinine clearance \>/= 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal. 8. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) starting the day entering the study, and for 60 days after injection of the imaging agent. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 9. Subjects with ECOG performance status of 0 or 1.

What this trial measures

  • Correlate LUM015 fluorescence in gastrointestinal cancers (pancreatic, esophageal, and colorectal) with pathology results1 day