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Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Lumicell, Inc.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Lumicell, Inc.
ClinicalTrials.gov Identifier:
NCT02584244
First received: October 16, 2015
Last updated: December 31, 2016
Last verified: December 2016
  Purpose
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 2.6 Imaging Device.

Condition Intervention
Colorectal Cancer Pancreatic Cancer Esophageal Cancer Drug: LUM015 Device: LUM 2.6 Imaging Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers

Resource links provided by NLM:


Further study details as provided by Lumicell, Inc.:

Primary Outcome Measures:
  • Determine optimal dose of LUM015 to be used according to tissue type based on optimal LUM015 activity in normal versus tumor tissue. [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • Assess toxicity in patients with gastrointestinal cancers by monitoring adverse events, including clinically significant abnormalities in CBC and serum chemistry tests from injection until first post-operative visit [ Time Frame: 2 weeks ]
  • Determine initial efficacy of LUM015 in labeling gastrointestinal cancers for molecular imaging by comparing imaging results with pathology. [ Time Frame: 1 day ]

Estimated Enrollment: 21
Study Start Date: May 2016
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LUM Imaging System
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 12 patients will be recruited at the dose level that produces optimal LUM015 activity. Patients will undergo their planned surgical resection 2-6 hours after LUM015 injection. All surgical specimens will be sent to the pathology suite for imaging with the LUM 2.6 Imaging Device and routine diagnostic assessment.
Drug: LUM015 Device: LUM 2.6 Imaging Device

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 2.6 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 in an office visit and undergo routine preoperative testing within four weeks of their planned surgery. During the pre-surgery visit a complete history and physical examination and standard of care pre-operative laboratory studies (including ECG) will be performed. On the day of their planned surgery, LUM015 will be administered by bolus intravenous injection 2-6 hours prior to surgery in the preoperative area. The patient will be monitored for adverse events until discharged from the hospital. Follow up of subjects will continue until their first post-operative visit.

Patients will undergo their planned surgical resection 2-6 hours after LUM015 is administered. All the surgical specimens (whether containing normal tissue or tumor tissue) will be sent to the pathology suite for imaging with the LUM 2.6 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, the patient 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have histologically or cytologically confirmed esophageal, colorectal or pancreatic adenocarcinoma (inclusive of high grade dysplasia) 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.
  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
    • 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 anaphylactic reaction attributed to any contrast agent or drugs containing polyethylene glycol (PEG).
  6. Pregnant women or lactating women
  7. Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception upon entering the study.
  8. HIV-positive individuals on combination antiretroviral therapy.
  9. Any subject for whom the investigator feels participation is not in the best interest of the subject.
  10. Subjects previously treated with systemic therapies to treat cancer, such as neo-adjuvant chemotherapy or hormonal therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02584244

Contacts
Contact: Jorge Ferrer, Ph.D 617-571-0592 jmferrr@lumicell.com
Contact: Lori Gilmartin lgilmartin@lumicell.com

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Andrew Chan, MD, Ph.D         
Sponsors and Collaborators
Lumicell, Inc.
National Cancer Institute (NCI)
Investigators
Principal Investigator: Andrew T Chan, M.D., Ph.D Massachusetts General Hospital
  More Information

Responsible Party: Lumicell, Inc.
ClinicalTrials.gov Identifier: NCT02584244     History of Changes
Other Study ID Numbers: LUM-015/2.6-002
P50CA127003 ( U.S. NIH Grant/Contract )
Study First Received: October 16, 2015
Last Updated: December 31, 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Head and Neck Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on July 21, 2017