Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lumicell, Inc.
• Collaborator: National Cancer Institute (NCI)

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)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.