ICG-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes

Phase 1

• Conditions: Prostate Cancer
• Interventions: Drug: Indocyanine Green (ICG)

• Registration Number: NCT02840617
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-03
• Status Verified: 2016-07
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-07-18
• Last Update Submitted: 2016-07-18
• Study First Posted: 2016-07-21
• Last Update Posted: 2016-07-21
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Histologically confirmed prostate cancer;
• Able to accept total prostatectomy;
• Patient has given its informed consent.

Exclusion Criteria

• Allergic to ICG or iodine;
• High-grade hepatic insufficiency
• refuse attending the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICG injection group	Indocyanine Green (ICG)	ICG will be intravenously administered over a 10 second period immediately after the patient was anesthetized. The fluorescence will be performed during and after the surgery, respectively.

Primary Outcome Measures

Name	Time	Method
sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer	1 week post-surgery	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

Secondary Outcome Measures

Name	Time	Method
sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes	1 week post-surgery	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

Trial Locations

Locations (1)

The department of Ultrasound, the third affiliated hospital of Sun Yat-son University; 🇨🇳 Guangzhou, Guangdong, China