This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of prostate tumors and metastatic lymph nodes. By correlating the ICG fluorescence patterns with pathologically confirmed tumor and nodal status, it would be possible to use fluorescence navigation system in helping prostate biopsy and lymph node dissection in the future.
The investigators will conduct an in vivo and in vitro pilot study in order to evaluate the diagnostic performance of fluorescence in the detection of prostate cancer and metastatic lymph nodes. All the patients included in this study will receive a radical prostatectomy after intravenous injection of 0.4 mg/Kg of ICG. ICG will be administered immediately after the patient is anesthetized. The fluorescence analysis will be performed intraoperatively by laparoscopic imaging and after surgery by hand-held imaging. The prostate or lymph nodes specimen with or without fluorescence signal will be sent to the Department of Pathology for pathological analysis. The histopathological procedure will be performed without knowledge of fluorescence analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
50
The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
Guangzhou, Guangdong, China
RECRUITINGsensitivity and specificity of the ICG-based fluorescence to detect prostate cancer
sensitivity (true positive) and specificity (true negative) of the ICG-based fluorescence to detect prostate cancer in vivo and in vitro compared to histological analysis
Time frame: 1 week post-surgery
sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes
sensitivity (true positive) and specificity (true negative) of the ICG-based fluorescence to detect metastatic lymph nodes in vivo and in vitro compared to histological analysis
Time frame: 1 week post-surgery
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