NCT02584244 · Lumicell, Inc.
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
What this study is about
The overall goal of this feasibility study is to assess the initial safety and effectiveness of LUM015 in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging System.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects must have histologically or cytologically confirmed esophageal, colorectal or pancreatic adenocarcinoma (inclusive of high grade dysplasia and cystic neoplasms) on a biopsy prior to surgery and must be scheduled for surgical resection, inclusive of endoscopic mucosal resection, of the primary tumor. Subjects at any cancer stage will be enrolled.
- Subjects may have previously received pre-operative radiation therapy and neoadjuvant chemotherapy.
- Age of 18 years or older.
- Subjects must be able and willing to follow study procedures and instructions.
- Subjects must have received and signed an informed consent form.
- Subjects must be sufficiently healthy to undergo surgery or an endoscopic procedure.
- Subjects must have normal organ and marrow function as defined below:
- 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.
- 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.
- Subjects with ECOG performance status of 0 or 1.
Exclusion criteria
- Subjects who have taken an investigational drug within 30 days of enrollment.
- Subjects with QTc interval \> 480ms.
- Subjects who have not recovered from adverse events due to pharmaceutical or diagnostic agents administered more than 4 weeks earlier.
- Subjects with uncontrolled hypertension defined as persistent systolic blood pressure \> 180 mm Hg, or diastolic blood pressure \> 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy
- History of allergic reaction attributed to drugs containing polyethylene glycol (PEG)
- History of allergic reaction to oral or intravenous contrast agents.
- Pregnant women or lactating women
- Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception upon entering the study.
- HIV-positive individuals on combination antiretroviral therapy.
- Any subject for whom the investigator feels participation is not in the best interest of the subject.
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 16, 2026 · Source of record for eligibility and locations