NCT02119858

Diffuse Optical Imaging With Indocyanine Green Solution in Imaging Pelvic Lymph Nodes in Patients With Stage II Prostate Cancer Undergoing Surgery

A Prospective Investigation of Near Infrared Fluorescence Imaging of Pelvic Lymph Nodes Using Indocyanine Green on the da Vinci Surgical System During Radical Prostatectomy and Pelvic Lymphadenectomy for Localized Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies diffuse optical imaging with indocyanine green solution in imaging pelvic lymph nodes in patients with stage II prostate cancer undergoing surgery. Indocyanine green solution is a special dye that can help doctors see the lymph nodes and blood vessels during surgery when visualized under diffuse optical imaging. Indocyanine green solution may improve the ability to detect lymph nodes and may lead to improved accuracy of lymph node removal.

Detailed description

PRIMARY OBJECTIVES: I. To determine the ability of indocyanine green (indocyanine green solution) (ICG) to highlight pelvic lymphatic tissue with fluorescence during robot assisted radical prostatectomy using near infrared fluorescence (diffuse optical imaging). SECONDARY OBJECTIVES: I. To evaluate the ability of this technique to improve lymph node yield, providing a potential therapeutic benefit to these patients by removing additional lymph nodes that may otherwise have been missed. OUTLINE: Patients receive indocyanine green transperineally and undergo diffuse optical imaging during robot-assisted laparoscopic radical prostatectomy with bilateral lymph node dissection using the da Vinci Robotic Surgical System. After completion of study treatment, patients are followed up for 1-2 weeks.

Conditions

• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Interventions

Type	Name	Description
DRUG	indocyanine green solution	Given transperineally
OTHER	diffuse optical imaging	Undergo near infrared fluorescence imaging
PROCEDURE	robot-assisted laparoscopic surgery	Undergo robot-assisted laparoscopic radical prostatectomy
PROCEDURE	therapeutic lymphadenectomy	Undergo lymphadenectomy

Timeline

• Start date: 2014-07-25
• Primary completion: 2018-02-07
• Completion: 2018-02-07
• First posted: 2014-04-22
• Last updated: 2018-02-22

Locations

1 site across 1 country: United States