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A Pilot and Feasibility Study of Indocyanine Green-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
Guangzhou, Guangdong, China
Start Date
March 1, 2016
Primary Completion Date
December 1, 2018
Last Updated
July 21, 2016
50
ESTIMATED participants
Indocyanine Green (ICG)
DRUG
Lead Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
NCT04550494
NCT06842498
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05691465