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

NCT ID: NCT02840617

Last Updated: 2016-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Brief Summary

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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

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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

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Indocyanine Green (ICG)

Intervention Type DRUG

Interventions

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Indocyanine Green (ICG)

Intervention Type DRUG

Other Intervention Names

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ICG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Rongqin Zheng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rongqin Zheng RQ Zheng, doctor

Role: STUDY_CHAIR

Third Affiliated Hospital, Sun Yat-Sen University

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Rongqin Zheng RQ Zheng, doctor

Role: CONTACT

0086-02085252010

Huichao Zhou HC Zhou, doctor

Role: CONTACT

0086-02085252010

Facility Contacts

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Rongqin RQ Zheng, doctor

Role: primary

0086-02085252010

Hui-chao HC Zhou, doctor

Role: backup

0086-02085252374

References

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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.

Reference Type BACKGROUND
PMID: 23957947 (View on PubMed)

Other Identifiers

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sysu160511

Identifier Type: -

Identifier Source: org_study_id

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