Status:
TERMINATED
Feasibility of the LUM Imaging System for Detection of Prostate Cancer
Lead Sponsor:
Lumicell, Inc.
Conditions:
Prostate Cancer
Neoplasm, Residual
Eligibility:
MALE
40+ years
Phase:
PHASE1
PHASE2
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 devi...
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 devi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2021
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03441464
Start Date
March 20 2019
End Date
February 11 2021
Last Update
February 25 2022
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10044