search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Indocyanine Green (ICG)
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring ICG, prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • The department of Ultrasound, the third affiliated hospital of Sun Yat-son UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG injection group

Arm Description

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.

Outcomes

Primary Outcome Measures

sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer
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

sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes
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

Full Information

First Posted
July 5, 2016
Last Updated
July 18, 2016
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
search

1. Study Identification

Unique Protocol Identification Number
NCT02840617
Brief Title
ICG-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
Official Title
A Pilot and Feasibility Study of Indocyanine Green-based Fluorescence Imaging in Localization of Prostate Cancer and Metastatic Lymph Nodes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
ICG, prostate cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICG injection group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green (ICG)
Other Intervention Name(s)
ICG
Primary Outcome Measure Information:
Title
sensitivity and specificity of the ICG-based fluorescence to detect prostate cancer
Description
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
Time Frame
1 week post-surgery
Secondary Outcome Measure Information:
Title
sensitivity and specificity of the ICG-based fluorescence imaging to detect metastatic lymph nodes
Description
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
Time Frame
1 week post-surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rongqin Zheng RQ Zheng, doctor
Phone
0086-02085252010
Email
zhengrq@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huichao Zhou HC Zhou, doctor
Phone
0086-02085252010
Email
zhcgrace@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongqin Zheng RQ Zheng, doctor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
The department of Ultrasound, the third affiliated hospital of Sun Yat-son University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongqin RQ Zheng, doctor
Phone
0086-02085252010
Email
zssyzrq@163.com
First Name & Middle Initial & Last Name & Degree
Hui-chao HC Zhou, doctor
Phone
0086-02085252374
Email
zhcgrace@163.com
First Name & Middle Initial & Last Name & Degree
Rongqin RQ Zheng, doctor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23957947
Citation
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. Erratum In: Eur Urol. 2015 Mar;67(3):e64.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs