NCT02840617

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

A Pilot and Feasibility Study of Indocyanine Green-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Indocyanine Green (ICG)

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-12-01
• First posted: 2016-07-21
• Last updated: 2016-07-21

Locations

1 site across 1 country: China