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LUM Imaging System for Gastrointestinal Cancer

Phase 1 & 2
Recruiting
Led By Andrew T Chan, M.D., Ph.D
Research Sponsored by Lumicell, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have histologically or cytologically confirmed esophageal, colorectal or pancreatic adenocarcinoma on a biopsy prior to surgery and must be scheduled for surgical resection
Subjects must have normal organ and marrow function as defined
Must not have
HIV-positive individuals on combination antiretroviral therapy
Subjects with uncontrolled hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer-detecting system that uses far-red imaging. The goal is to see if it's safe and effective in detecting colorectal, pancreatic, and esophageal adenocarcinomas.

Who is the study for?
This trial is for adults over 18 with confirmed gastrointestinal cancers (esophageal, colorectal, or pancreatic) who are scheduled for surgery. They must have normal organ function and blood counts, be able to follow study procedures, and not be pregnant. Participants should use contraception during the study.
What is being tested?
The LUM Imaging System's safety and effectiveness in identifying cancerous tissue during surgery is being tested. It involves a drug called LUM015 used with an imaging device to highlight tumors in the digestive tract.
What are the potential side effects?
Potential side effects aren't specified here but generally could include reactions at the injection site of LUM015, issues related to contrast agents like allergic reactions or kidney problems from dye used in imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed diagnosis of esophageal, colorectal, or pancreatic cancer and am scheduled for surgery.
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My organs and bone marrow are functioning normally.
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I am fully active or can carry out light work.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV-positive and on combination antiretroviral therapy.
Select...
My blood pressure is not controlled by medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Group I: Patients with esophageal cancerExperimental Treatment2 Interventions
The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Group II: Patients with early stage gastric cancer or precancerous lesionsExperimental Treatment2 Interventions
The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Group III: Patients with colorectal cancerExperimental Treatment2 Interventions
The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Group IV: Pancreatic cancer patients receiving neoadjuvant chemotherapyExperimental Treatment2 Interventions
The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Group V: Pancreatic cancer patients not receiving neoadjuvant chemoExperimental Treatment2 Interventions
The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Group VI: Gastric cancer patients who have received neoadjuvant therapyExperimental Treatment2 Interventions
The first 3 patients will be injected at a dose of 0.5 mg/kg. If no or minimal activity is observed and no serious adverse events occur, the subsequent three patients will be injected with the second tier dose level of 1.0 mg/kg. If no or minimal activity is observed in in the second tier dosing group, and no serious adverse events occur, the following three patients will have the third tier dose of 1.5 mg/kg administered. An additional 2 patients will be recruited at the dose level that produces optimal LUM015 activity. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LUM015
2012
Completed Phase 2
~80
LUM 2.6 Imaging Device
2015
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Lumicell, Inc.Lead Sponsor
8 Previous Clinical Trials
873 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,972 Total Patients Enrolled
Andrew T Chan, M.D., Ph.DPrincipal InvestigatorMassachusetts General Hospital

Media Library

LUM015 Clinical Trial Eligibility Overview. Trial Name: NCT02584244 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Pancreatic cancer patients not receiving neoadjuvant chemo, Patients with colorectal cancer, Patients with esophageal cancer, Pancreatic cancer patients receiving neoadjuvant chemotherapy, Gastric cancer patients who have received neoadjuvant therapy, Patients with early stage gastric cancer or precancerous lesions
Colorectal Cancer Clinical Trial 2023: LUM015 Highlights & Side Effects. Trial Name: NCT02584244 — Phase 1 & 2
LUM015 2023 Treatment Timeline for Medical Study. Trial Name: NCT02584244 — Phase 1 & 2
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