RECRUITING

Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

Conditions

Colorectal Cancer Pancreatic Cancer Esophageal Cancer Gastric Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

Quick Facts

Study Start:2016-08-04

Study Completion:2025-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02584244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Jorge Ferrer, Ph.D

CONTACT

617-571-0592

jmferrr@lumicell.com

Kate Smith, MPH

CONTACT

781-218-3268

kate@lumicell.com

Principal Investigator

Andrew T Chan, M.D., Ph.D

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Lumicell, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-08-04

Study Completion Date2025-04

Study Record Updates

Study Start Date2016-08-04

Study Completion Date2025-04

Terms related to this study

Additional Relevant MeSH Terms

Colorectal Cancer
Pancreatic Cancer
Esophageal Cancer
Gastric Cancer