Feasibility of the LUM Imaging System for Detection of Prostate Cancer

• ClinicalTrials.gov Identifier: NCT03441464
• Recruitment Status: Terminated
• First Posted: February 22, 2018
• Last Update Posted: February 25, 2022
• Sponsor: Lumicell, Inc.
• Information provided by (Responsible Party): Lumicell, Inc.

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer; Neoplasm, Residual	Combination Product: LUM Imaging System	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Dose escalation
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Feasibility of the LUM Imaging System for Detection of Prostate Cancer
• Actual Study Start Date: March 20, 2019
• Actual Primary Completion Date: February 11, 2021
• Actual Study Completion Date: February 11, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1st Tier Dose Level; 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.	Combination Product: LUM Imaging System; 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.
Experimental: 2nd Tier Dose Leel; 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.	Combination Product: LUM Imaging System; 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.
Experimental: 3rd Tier Dose Level; 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.	Combination Product: LUM Imaging System; 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.
No Intervention: Auto-fluorescence; 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

Outcome Measures

Primary Outcome Measures :

1. Determine initial efficacy of LUM015 in labeling prostate cancer by molecular imaging by comparing imaging results with pathology [ Time Frame: Day 1 ]
   Correlate the fluorescence levels in tumor tissue from ex-vivo specimen imaging to the dose of LUM015 injected.

Secondary Outcome Measures :

1. Number of patients with reported adverse 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Patients with established diagnosis of prostate cancer
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10044

Sponsors and Collaborators

Lumicell, Inc.

Investigators

• Principal Investigator: Ashutosh Tewari, MD; Icahn School of Medicine at Mount Sinai

More Information

• Responsible Party: Lumicell, Inc.
• ClinicalTrials.gov Identifier: NCT03441464
• Other Study ID Numbers: CL0005
• First Posted: February 22, 2018
• Last Update Posted: February 25, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Lumicell, Inc.:

Fluorescence; Prostate; Cancer detection

Additional relevant MeSH terms:

Prostatic Neoplasms; Neoplasm, Residual; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Neoplastic Processes; Pathologic Processes