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

Overview

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.

Full Title of Study: “A Pilot and Feasibility Study of Indocyanine Green-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2018

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.

Interventions

  • Drug: Indocyanine Green (ICG)

Arms, Groups and Cohorts

  • Experimental: ICG injection group
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer
    • Time Frame: 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 Measures

  • sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Third Affiliated Hospital, Sun Yat-Sen University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rongqin Zheng, Professor – Third Affiliated Hospital, Sun Yat-Sen University
  • Overall Official(s)
    • Rongqin Zheng RQ Zheng, doctor, Study Chair, Third Affiliated Hospital, Sun Yat-Sen University
  • Overall Contact(s)
    • Rongqin Zheng RQ Zheng, doctor, 0086-02085252010, zhengrq@mail.sysu.edu.cn

References

Greco F, Cadeddu JA, Gill IS, Kaouk JH, Remzi M, Thompson RH, van Leeuwen FW, van der Poel HG, Fornara P, Rassweiler J. Current perspectives in the use of molecular imaging to target surgical treatments for genitourinary cancers. Eur Urol. 2014 May;65(5):947-64. doi: 10.1016/j.eururo.2013.07.033. Epub 2013 Aug 7. Review. Erratum in: Eur Urol. 2015 Mar;67(3):e64.

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