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Trial record 4 of 23 for:    Recruiting, Enrolling by invitation Studies | Interventional Studies | Glioma | United States | Start date from 04/01/2019 to 07/31/2019

Feasibility of the LUM Imaging System for Detection of Cancer to the Brain

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ClinicalTrials.gov Identifier: NCT03717142
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Lumicell, Inc.

Tracking Information
First Submitted Date  ICMJE October 22, 2018
First Posted Date  ICMJE October 24, 2018
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE May 3, 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
Correlation of fluorescence levels in normal and tumor tissue by dose of LUM015 [ Time Frame: Day 1 ]
Correlate the fluorescence levels in normal and tumor tissue from specimen imaging to the dose of LUM015 injected, or if not injected. Determine initial efficacy of LUM015 in labeling primary and metastatic cancer in the Brain by molecular imaging compared with imaging results in pathology.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
Determine initial efficacy of LUM015 in labeling primary and metastatic cancer in the Brain by molecular imaging compared with imaging results in pathology [ Time Frame: Day 1 ]
Correlate the fluorescence levels in normal and tumor tissue from specimen imaging to the dose of LUM015 injected, or if not injected.
Change History Complete list of historical versions of study NCT03717142 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
Number of reported safety events [ Time Frame: up to 14 days 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
 (submitted: October 22, 2018)
Collect safety data of LUM015 in subjects [ Time Frame: up to 14 days post surgery ]
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity
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 Detection of Cancer to the Brain
Official Title  ICMJE Feasibility of the LUM Imaging System for In Vivo and Ex Vivo Detection of Cancer in Subjects With Low Grade Gliomas, Glioblastomas, and Cancer Metastases to the Brain
Brief Summary The overall objective of this study is to assess the safety and efficacy of the LUM Imaging System in imaging primary and metastatic cancer in the brain. This includes selecting a dose to determine the initial efficacy of LUM015 for the molecular imaging of low-grade gliomas, glioblastomas and cancer masses that have metastasized to the brain.
Detailed Description

The primary objective of this feasibility study is to identify an effective dose of LUM015 for imaging low grade gliomas, glioblastomas and cancer metastases to the brain. The optimal dose will be used for future studies. Both normal brain tissue and tumor tissue will be imaged and analyzed using the LUM Imaging device. The LUM Imaging System is a combination product consisting of the LUM Imaging Device and the imaging agent LUM015.

Subjects with a possible diagnosis of low grade glioma, glioblastoma and metastases to the brain, and scheduled for surgical resection, will be screened, recruited. On day of scheduled surgery, the subject will be administered with LUM015 4 ± 2 hours prior to using LUM Imaging System during surgery. LUM015 will be administered via peripheral intravenous (IV) injection as a single dose between 1.0 - 3.0 mg/kg.

Before the tumor mass is resected, the LUM Imaging Device will be used to scan images of distinct areas of grossly normal appearing brain tissue and, separately, images of distinct areas of grossly appearing tumor. Following tumor mass resection, the tumor bed is scanned to record in vivo images. The resected tissue will also be imaged ex vivo.

All subjects will continue to be monitored until hospital discharge and followed through their first standard of care post-surgical visit. Subjects with adverse events that are determined to be possibly related to the investigational product will continue to 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
  • Low Grade Glioma of Brain
  • Glioblastoma
  • Metastasis to Brain
Intervention  ICMJE Combination Product: LUM Imaging System
Patients will be injected with one of 3 study doses of LUM015, or have no LUM015 intervention, and tissue will be imaged in vivo and ex vivo with the LUM imaging device.
Study Arms  ICMJE
  • No Intervention: Auto-fluorescence
    No LUM015 injection will be given to three (3) patients, in each indication, to measure baseline tissue fluorescence. Imaging with the LUM imaging device will be performed in vivo and ex vivo on surgical tissue.
  • Experimental: 1st Tier Dose Level
    3 patients, in each indication, 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
    3 patients, in each indication, will be administered a single dose of LUM015 at 2.0 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: 3rd Tier Dose Level
    After an interim analysis, the dosing for the 3 patients, in each indication, will be administered a single dose of LUM015 of no greater than 3.0 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
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: October 22, 2018)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has radiologic imaging with a presumed diagnosis of low grade gliomas, glioblastoma/ grade III glioma or cancer metastases to the brain and must be scheduled for surgical resection
  • Male or female subjects 18 years of age or older
  • Subjects must have normal liver, kidney, and bone marrow function as defined below:

    • Leukocytes > 3,000/mcL
    • Platelets > 100,000/mcL
    • total bilirubin within normal institutional limits
    • AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal
    • Creatinine ≤ 1.5 mg/dL 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
  • Subjects with ECOG performance status of 0 or 1

Exclusion Criteria:

  • Subjects previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy.
  • Subjects with a known current condition of substance addiction.
  • Subjects who have taken an investigational drug within 30 days of enrollment or those who have not recovered from adverse events due to pharmaceutical or diagnostic agents.
  • 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 stable within these ranges 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.
  • Subjects who are pregnant or nursing.
  • 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 are ineligible because of the potential for pharmacokinetic interactions with LUM015.
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. 6174041040 jmferrer@lumicell.com
Contact: Kate Smith, MPH 617-404-1033 kate@lumicell.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03717142
Other Study ID Numbers  ICMJE CL0004
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
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Lumicell, Inc.
Study Sponsor  ICMJE Lumicell, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: E. Antonio Chiocca, MD, PhD Brigham and Women's 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