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

July 18, 2016 updated by: Rongqin Zheng, Third Affiliated Hospital, Sun Yat-Sen University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Huichao Zhou HC Zhou, doctor
  • Phone Number: 0086-02085252010
  • Email: zhcgrace@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
        • Contact:
          • Rongqin RQ Zheng, doctor
          • Phone Number: 0086-02085252010
          • Email: zssyzrq@163.com
        • Contact:
          • Hui-chao HC Zhou, doctor
          • Phone Number: 0086-02085252374
          • Email: zhcgrace@163.com
        • Principal Investigator:
          • Rongqin RQ Zheng, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Indocyanine Green (ICG)
Other Names:
  • ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Chair: Rongqin Zheng RQ Zheng, doctor, Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 5, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sysu160511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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