Feasibility of the LUM Imaging System for Detection of Prostate Cancer
Prostate Cancer, Neoplasm, Residual
About this trial
This is an interventional device feasibility trial for Prostate Cancer focused on measuring Fluorescence, Prostate, Cancer detection
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
Sites / Locations
- Icahn School of Medicine at Mount Sinai
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
No Intervention
1st Tier Dose Level
2nd Tier Dose Leel
3rd Tier Dose Level
Auto-fluorescence
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