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Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

Primary Purpose

Colorectal Cancer, Pancreatic Cancer, Esophageal Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LUM015
LUM 2.6 Imaging Device
Sponsored by
Lumicell, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Patients with colorectal cancer

Patients with esophageal cancer

Pancreatic cancer patients receiving neoadjuvant chemotherapy

Pancreatic cancer patients not receiving neoadjuvant chemo

Gastric cancer patients who have received neoadjuvant therapy

Patients with early stage gastric cancer or precancerous lesions

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Correlate LUM015 fluorescence in gastrointestinal cancers (pancreatic, esophageal, and colorectal) with pathology results

Secondary Outcome Measures

Number of safety events in humans with colorectal, pancreatic, and esophageal cancer.

Full Information

First Posted
October 16, 2015
Last Updated
May 8, 2023
Sponsor
Lumicell, Inc.
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02584244
Brief Title
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
Official Title
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2016 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumicell, Inc.
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
The overall goal of this feasibility study is to assess the initial safety and efficacy of a novel, intravenously administered cathepsin activatable imaging probe, LUM015, in ex vivo far-red imaging of colorectal, pancreatic, and esophageal cancers (adenocarcinoma) using the LUM Imaging Device. All subjects will have an established diagnosis of colorectal, pancreatic, or esophageal adenocarcinoma and are scheduled for resection of their primary tumors. Patients will be seen by their surgeon or endoscopist in an office visit and undergo routine preoperative testing within eight weeks of their planned procedure. During the pre-procedure visit a complete history and physical examination and standard of care pre-operative laboratory studies (including ECG) will be performed. These laboratory values and results of the history and physical will be used to confirm eligibility. For some patients, a pre-procedure visit is not required as part of standard treatment. Those patients may have a study-specific screening and pre-procedure laboratory tests at their local medical center. On the day of their planned surgery, LUM015 will be administered by bolus intravenous injection. For colorectal and esophageal cases, LUM015 will be administered 2-6 hours prior to tumor resection. For pancreatic cases, given the variability in predicting the time to tumor resection relative to surgical start time, injection will occur 1 hour prior to planned surgical start time. Patients will be monitored for adverse events until discharged from the hospital. Follow up of subjects will continue until their first post-operative visit. All surgical specimens (whether containing normal tissue or tumor tissue) will be sent to the pathology suite for imaging with the LUM Imaging Device and routine diagnostic assessment. Imaged areas showing high fluorescence will be marked to guide pathology evaluation and determine whether the area contains tumor. Samples of imaged areas showing low fluorescence signal will also be evaluated by pathology to determine whether the area only contains normal tissue. After imaging, part of this tissue will be fresh frozen for correlative studies. The patients are expected to be admitted to the hospital for the surgical procedure and remain in the hospital post-surgery as indicated and required by the surgeon per standard of care treatment. While in the hospital, patients will be assessed for adverse events. Laboratory studies will also be performed during this time as a part of routine post-surgical care and to assess for any imaging agent related adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Pancreatic Cancer, Esophageal Cancer, Gastric Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Six groups enrolling up to 11 patients each. Groups are patients with colorectal cancer, patients with esophageal cancer, patients with pancreatic cancer receiving neoadjuvant chemotherapy, patients with pancreatic cancer not receiving neoadjuvant chemotherapy, gastric cancer patients who have received neoadjuvant therapy, and patients with early stage gastric cancer or precancerous lesions
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with colorectal cancer
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients with esophageal cancer
Arm Type
Experimental
Arm Description
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.
Arm Title
Pancreatic cancer patients receiving neoadjuvant chemotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Pancreatic cancer patients not receiving neoadjuvant chemo
Arm Type
Experimental
Arm Description
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.
Arm Title
Gastric cancer patients who have received neoadjuvant therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Patients with early stage gastric cancer or precancerous lesions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LUM015
Intervention Type
Device
Intervention Name(s)
LUM 2.6 Imaging Device
Primary Outcome Measure Information:
Title
Correlate LUM015 fluorescence in gastrointestinal cancers (pancreatic, esophageal, and colorectal) with pathology results
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of safety events in humans with colorectal, pancreatic, and esophageal cancer.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Ferrer, Ph.D
Phone
617-571-0592
Email
jmferrr@lumicell.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kate Smith, MPH
Phone
781-218-3268
Email
kate@lumicell.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew T Chan, M.D., Ph.D
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Chan, MD, Ph.D

12. IPD Sharing Statement

Learn more about this trial

Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

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