Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT02119858
Status:
COMPLETED
Last Update Posted:
2018-02-22
First Post:
2014-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diffuse Optical Imaging With Indocyanine Green Solution in Imaging Pelvic Lymph Nodes in Patients With Stage II Prostate Cancer Undergoing Surgery
Sponsor:
City of Hope Medical Center
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: