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

Sun Yat-sen University

Status and phase: Unknown; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: Indocyanine Green (ICG)

Study type: Interventional

Funder types: Other

Identifiers

NCT02840617

sysu160511

Details and patient eligibility

About

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 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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

ICG injection group

Experimental group

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.

Treatment:

Drug: Indocyanine Green (ICG)