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Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03834272
Recruitment Status : Recruiting
First Posted : February 7, 2019
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Lumicell, Inc.

Tracking Information
First Submitted Date  ICMJE February 4, 2019
First Posted Date  ICMJE February 7, 2019
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE March 18, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
Initial efficacy of LUM015 in labeling peritoneal surface malignancies by molecular imaging by comparing imaging results with pathology [ Time Frame: 1 Day ]
Correlate the fluorescence levels in tumor tissue imaging to the dose of LUM015 injected.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03834272 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2019)
Number of patients with reported adverse events [ Time Frame: up to 5 weeks post surgery ]
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of the LUM Imaging System for Peritoneal Surface Malignancies
Official Title  ICMJE Feasibility of the LUM Imaging System for Detection of Peritoneal Surface Malignancies
Brief Summary This single-site, feasibility study to assess the initial safety and efficacy of the LUM Imaging System for in vivo imaging of metastases to the peritoneum from primary gastrointestinal cancer, ovarian cancer and mesothelioma. This feasibility study consists of two parts: (a) a dose escalation phase to select the optimal dose followed by (b) enrollment of additional patients to develop the tumor detection algorithm.
Detailed Description

This study is being conducted to see if LUM015 can be safely given to human patients before surgery at a dose that allows the removed tumor tissue to be identified when imaged by the LUM imaging device.

The first 6 subjects will receive an intravenous injection of LUM015 intraoperatively with a dose of either 1.0 mg/kg or 1.5 mg/kg. The first three subjects will receive a dose of 1.0 mg/kg and if there are no adverse events the next three subject will receive the increased dose of 1.5 mg/kg. LUM015 will be given through a vein in the arm.

When the final dose of LUM015 has been determined, 12 additional subjects will be given that final dose.

The sequence of events during the surgical procedure will vary based on the standard of care used by the surgeon. Study treatment ends when the surgery is completed. All patients will continue their enrollment in the study until their first follow-up visit and they will continue to be followed until the medical team determines no further surgical intervention is required. Patients with adverse events that are determined to be possibly related to the LUM Imaging System will be followed until resolution or stabilization of the adverse event.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Dose Escalation
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Peritoneal Metastases
Intervention  ICMJE Combination Product: LUM Imaging System
Patients will be injected with one of 2 study doses of LUM015 and tissue will be imaged in vivo and ex vivo with the LUM imaging device.
Study Arms  ICMJE
  • Experimental: 1st Tier Dose Level- LUM Imaging System
    3 patients will be administered a single dose of LUM015 at 1.0 mg/kg.Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue.
    Intervention: Combination Product: LUM Imaging System
  • Experimental: 2nd Tier Dose Level- LUM Imaging System
    3 patients will be administered a single dose of LUM015 at 1.5 mg/kg.Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue.
    Intervention: Combination Product: LUM Imaging System
  • Experimental: 3rd Tier Dose Level- LUM Imaging System
    12 patients will receive LUM015 at the dose and timepoint selected based on the analysis of the data
    Intervention: Combination Product: LUM Imaging System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2019)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must have histologically or cytologically confirmed metastases to the peritoneum from gastrointestinal cancer, ovarian cancer or mesothelioma prior to surgery.
  • Subjects must be scheduled for surgical resection.
  • 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 otherwise healthy except for the diagnosis of cancer, as per the criteria listed below.
  • Subjects must have normal organ and marrow function as defined as:

    • Leukocytes > 3,000/mcL
    • Absolute neutrophil count > 1,500/mcL
    • Platelets > 100,000/mcL
    • total bilirubin within normal institutional limits
    • 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.
  • Subjects with ECOG performance status of 0 or 1.

Exclusion Criteria:

  • Subjects who are pregnant or nursing at the time of diagnosis.
  • Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015.
  • Subjects who have taken an investigational drug within 30 days of enrollment.
  • Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents.
  • Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 100 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 any oral or intravenous contrast agents.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements.
  • HIV-positive individuals on combination antiretroviral therapy are ineligible.
  • Any subject for whom the investigator feels participation is not in the best interest of the subject.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jorge Ferrer, Ph.D. 617-4041040 jmferrer@lumicell.com
Contact: Kate Smith, MPH, CCRP 7815918378 ext 7815918378 kate@lumicell.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03834272
Other Study ID Numbers  ICMJE CLP-00010
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Lumicell, Inc.
Study Sponsor  ICMJE Lumicell, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James C Cusack, MD Massachusetts General Hospital
PRS Account Lumicell, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP