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Feasibility of the LUM Imaging System for Detection of Prostate Cancer

Primary Purpose

Prostate Cancer, Neoplasm, Residual

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

About this trial

This is an interventional device feasibility trial for Prostate Cancer focused on measuring Fluorescence, Prostate, Cancer detection

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with clinically localized or locally advanced prostate cancer and scheduled for radical prostatectomy
  • Age 40 years or older
  • Able and willing to follow study procedures and instructions
  • Received and signed informed consent form
  • Otherwise healthy except for diagnosis of cancer
  • Normal organ and marrow function as defined below:

    • Hemoglobin 13.9 - 16.3 g/dL
    • Leukocytes 4500 - 11,000 uL
    • Platelets 150,000 - 450,000 uL
    • Total bilirubin within normal institutional limits
    • AST (SGOT)/ALT (SGPT) within normal institutional limits
    • Creatinine within normal institutional limits or creatinine clearance within normal institutional limits
  • ECOG performance status of 0 or 1

Exclusion Criteria:

  • Known current substance addiction
  • Have taken an investigational drug within 30 days of enrollment
  • Received methylene blue prior to tissue excision
  • QT Interval > 480ms
  • Have not recovered from an adverse event due to pharmaceutical or diagnostic agent
  • Uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 100 mm Hg; 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
  • Sexually active subjects unwilling/unable to use medically acceptable forms of contraception during study participation
  • HIV-positive subjects on combination antiretroviral therapy
  • Investigator feels subject's participation is not in the best interest of the subject
  • Previously treated with local or systemic therapies to treat prostate cancer

Sites / Locations

  • Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

1st Tier Dose Level

2nd Tier Dose Leel

3rd Tier Dose Level

Auto-fluorescence

Arm Description

3 patients administered single dose of LUM015 at 0.5 mg/kg. Imaging with the LUM imaging device will be performed ex vivo on resected tissue.

3 patients administered single dose of LUM015 at 1.0 mg/kg. Imaging with the LUM imaging device will be performed ex vivo on resected tissue.

After evaluation of the fluorescence signal observed with the LUM imaging device in the three other cohorts,the subsequent 3 patients will receive a dose of 0.5-1.5 mg/kg.

No LUM015 injection will be given to three (3) patients to measure baseline tissue fluorescence. The tissue will still be imaged ex-vivo using the LUM Imaging Device

Outcomes

Primary Outcome Measures

Determine initial efficacy of LUM015 in labeling prostate cancer by molecular imaging by comparing imaging results with pathology
Correlate the fluorescence levels in tumor tissue from ex-vivo specimen imaging to the dose of LUM015 injected.

Secondary Outcome Measures

Number of patients with reported adverse events
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.

Full Information

First Posted
February 1, 2018
Last Updated
February 8, 2022
Sponsor
Lumicell, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03441464
Brief Title
Feasibility of the LUM Imaging System for Detection of Prostate Cancer
Official Title
Feasibility of the LUM Imaging System for Detection of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis indicated a change in study design to collect in vivo data
Study Start Date
March 20, 2019 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
February 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lumicell, Inc.

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
No

5. Study Description

Brief Summary
The primary objective of this feasibility study is to determine if administration of LUM015 will result in positive fluorescence of tumor tissue from ex vivo specimen imaging with the LUM Imaging device from patients undergoing radical prostatectomy for prostate cancer. Both normal tissue and tumor tissue will be imaged and analyzed. The LUM Imaging System is a portable combination product consisting of an imaging device and an imaging agent (LUM015). Patients with an established diagnosis of prostate cancer and who are eligible for radical prostatectomy will be screened. Eligible patients will be enrolled and on the day of their planned surgery, LUM015 will be administered 2-6 hours prior to surgery. Patients will undergo radical prostatectomy 2-6 hours after LUM015 administration. All surgical specimens will be imaged with the LUM imaging device and have routine diagnostic assessment. Patients will be monitored for adverse events from time of injection through the first standard of care post-surgical follow-up visit.
Detailed Description
The primary objective of this feasibility study is to determine if administration of LUM015 will result in positive fluorescence of tumor tissue from ex vivo specimen imaging with the LUM Imaging device from patients undergoing radical prostatectomy for prostate cancer. Both normal tissue and tumor tissue will be imaged and analyzed. The LUM Imaging System is a portable combination product consisting of an imaging device and an imaging agent (LUM015). Patients with an established diagnosis of adenocarcinoma of the prostate and who are eligible for radical prostatectomy will be screened. Patients will be seen by their surgeon in an office visit and undergo routine preoperative testing within 8 weeks of their planned procedure. After obtaining informed consent and confirming eligibility, patients will be enrolled and on the day of their planned surgery, LUM015 will be administered by bolus intravenous injection 2-6 hours prior to surgery. This injection is the only procedure that will be performed on patients outside of their routine care (standard of care). LUM015 will be administered in a single dose between 0.5 -1.5 mg/kg in up to 9 patients. An additional 3 patients will not be injected with LUM015, but their specimens will undergo LUM imaging. Patients will undergo radical prostatectomy 2-6 hours after LUM015 administration. All surgical specimens will be sent to the pathology suite for imaging with the LUM imaging device and routine diagnostic assessment. Imaging will be performed on the resected specimens. Alternatively, specimens can also be imaged in the operating room. Imaged areas showing high fluorescence will be marked with ink 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. Additional resection will not be performed if a positive surgical margin is detected by imaging. Patients are expected to be admitted to the hospital for the surgical procedure and will remain in the hospital post-surgery per standard of care treatment. Laboratory studies will be performed to assess for any imaging agent related adverse events prior to hospital discharge and at the standard of care post-surgical follow-up visit. Patients will be followed through their first standard of care post-surgical visit. Additionally, patients will be monitored for adverse events from time of injection through the first standard of care post-surgical visit. Patients with adverse events that are possibly related to LUM015 will be followed until resolution or stabilization of the adverse event.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Neoplasm, Residual
Keywords
Fluorescence, Prostate, Cancer detection

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Dose escalation
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1st Tier Dose Level
Arm Type
Experimental
Arm Description
3 patients administered single dose of LUM015 at 0.5 mg/kg. Imaging with the LUM imaging device will be performed ex vivo on resected tissue.
Arm Title
2nd Tier Dose Leel
Arm Type
Experimental
Arm Description
3 patients administered single dose of LUM015 at 1.0 mg/kg. Imaging with the LUM imaging device will be performed ex vivo on resected tissue.
Arm Title
3rd Tier Dose Level
Arm Type
Experimental
Arm Description
After evaluation of the fluorescence signal observed with the LUM imaging device in the three other cohorts,the subsequent 3 patients will receive a dose of 0.5-1.5 mg/kg.
Arm Title
Auto-fluorescence
Arm Type
No Intervention
Arm Description
No LUM015 injection will be given to three (3) patients to measure baseline tissue fluorescence. The tissue will still be imaged ex-vivo using the LUM Imaging Device
Intervention Type
Combination Product
Intervention Name(s)
LUM Imaging System
Intervention Description
Patients will be injected with one of 3 study doses of LUM015, or have no LUM015 intervention, and resected tissue will be imaged ex vivo with the LUM imaging device.
Primary Outcome Measure Information:
Title
Determine initial efficacy of LUM015 in labeling prostate cancer by molecular imaging by comparing imaging results with pathology
Description
Correlate the fluorescence levels in tumor tissue from ex-vivo specimen imaging to the dose of LUM015 injected.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of patients with reported adverse events
Description
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
Time Frame
Up to 14 days post surgery

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Patients with established diagnosis of prostate cancer
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with clinically localized or locally advanced prostate cancer and scheduled for radical prostatectomy Age 40 years or older Able and willing to follow study procedures and instructions Received and signed informed consent form Otherwise healthy except for diagnosis of cancer Normal organ and marrow function as defined below: Hemoglobin 13.9 - 16.3 g/dL Leukocytes 4500 - 11,000 uL Platelets 150,000 - 450,000 uL Total bilirubin within normal institutional limits AST (SGOT)/ALT (SGPT) within normal institutional limits Creatinine within normal institutional limits or creatinine clearance within normal institutional limits ECOG performance status of 0 or 1 Exclusion Criteria: Known current substance addiction Have taken an investigational drug within 30 days of enrollment Received methylene blue prior to tissue excision QT Interval > 480ms Have not recovered from an adverse event due to pharmaceutical or diagnostic agent Uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 100 mm Hg; 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 Sexually active subjects unwilling/unable to use medically acceptable forms of contraception during study participation HIV-positive subjects on combination antiretroviral therapy Investigator feels subject's participation is not in the best interest of the subject Previously treated with local or systemic therapies to treat prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashutosh Tewari, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10044
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of the LUM Imaging System for Detection of Prostate Cancer

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