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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02840617
• Other study ID #: sysu160511
• Status: Recruiting
• Phase: Phase 1
• First received: July 5, 2016
• Last updated: July 18, 2016
• Start date: March 2016

Study information

• Verified date: July 2016
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Rongqin Zheng RQ Zheng, doctor
• Phone: 0086-02085252010
• Email: zhengrq[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Indocyanine Green (ICG)

Locations

Country	Name	City	State
China	The department of Ultrasound, the third affiliated hospital of Sun Yat-son University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 week post-surgery	No
Secondary	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	1 week post-surgery	No