Using LUM Imaging System to detect gastrointestinal cancers

Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

This study is testing a new imaging tool called LUM015 to see if it can help doctors find colorectal, pancreatic, and esophageal cancers more easily during surgery for patients who have these types of tumors.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Lumicell, Inc. (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT02584244 on ClinicalTrials.gov

What this trial studies

This feasibility study aims to evaluate the safety and efficacy of LUM015, a novel imaging probe, for detecting colorectal, pancreatic, and esophageal cancers during surgical procedures. Patients with confirmed adenocarcinoma who are scheduled for tumor resection will receive LUM015 via intravenous injection prior to surgery. The study will assess the effectiveness of the LUM Imaging System in visualizing tumors ex vivo, potentially improving surgical outcomes. Participants will undergo routine preoperative evaluations to confirm eligibility.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with confirmed colorectal, pancreatic, or esophageal adenocarcinoma scheduled for surgical resection.

Not a fit: Patients with cancers other than colorectal, pancreatic, or esophageal adenocarcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the accuracy of cancer detection during surgery, leading to better patient outcomes.

How similar studies have performed: Other studies utilizing advanced imaging techniques for cancer detection have shown promising results, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

1. 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.
2. Subjects may have previously received pre-operative radiation therapy and neoadjuvant chemotherapy.
3. Age of 18 years or older.
4. Subjects must be able and willing to follow study procedures and instructions.
5. Subjects must have received and signed an informed consent form.
6. Subjects must be sufficiently healthy to undergo surgery or an endoscopic procedure.
7. 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.
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.

Exclusion Criteria:

1. Subjects who have taken an investigational drug within 30 days of enrollment.
2. Subjects with QTc interval \> 480ms.
3. Subjects who have not recovered from adverse events due to pharmaceutical or diagnostic agents administered more than 4 weeks earlier.
4. 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
5. History of allergic reaction attributed to drugs containing polyethylene glycol (PEG)
6. History of allergic reaction to oral or intravenous contrast agents.
7. Pregnant women or lactating women
8. Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception upon entering the study.
9. HIV-positive individuals on combination antiretroviral therapy.
10. Any subject for whom the investigator feels participation is not in the best interest of the subject.

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Andrew T Chan, M.D., Ph.D — Massachusetts General Hospital
• Study coordinator: Jorge Ferrer, Ph.D

Conditions: Colorectal Cancer, Pancreatic Cancer, Esophageal Cancer, Gastric Cancer