Feasibility of the LUM Imaging System for Detection of Prostate Cancer

NCT03441464 | Terminated Phase 1 FDA Drug FDA Device

• 1 other identifier: CL0005
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Neoplasm, Residual

Keywords

Fluorescence; Prostate; Cancer detection

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (1)

• Number of patients with reported adverse events

  Up to 14 days post surgery

Study Arms (4)

1st Tier Dose Level

EXPERIMENTAL

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

2nd Tier Dose Leel

EXPERIMENTAL

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

3rd Tier Dose Level

EXPERIMENTAL

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

Auto-fluorescence

NO INTERVENTION

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

Interventions

LUM Imaging System COMBINATION_PRODUCT

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.

1st Tier Dose Level; 2nd Tier Dose Leel; 3rd Tier Dose Level

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Patients with established diagnosis of prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lumicell, Inc.: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10044, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasm, Residual

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ashutosh Tewari, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 22, 2018
• Study Start: March 20, 2019
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)