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

Stage IIB Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119858
• Other study ID #: 14015
• Secondary ID: NCI-2014-0071114
• Status: Completed
• Phase: Phase 1
• First received: April 9, 2014
• Last updated: February 19, 2018
• Start date: July 25, 2014
• Est. completion date: February 7, 2018

Study information

• Verified date: February 2018
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 7, 2018
• Est. primary completion date: February 7, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Stage 2, intermediate to high risk (per D'Amico criteria) localized prostate cancer with a prostate gland size =< 100 grams

• Intermediate risk: prostate specific antigen (PSA) between 10-20, Gleason grade 7, or clinical stage T2b

• High risk: PSA > 20 , Gleason grade >= 8, or clinical stage >= T2c

• Life expectancy of at least 10 years

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• The subject must be able to comply with the study procedures

• All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

• Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin > 1.5 x normal

• Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as serum glutamic oxaloacetic transaminase (SGOT) > 2 x normal

• Prior prostate surgery (i.e. transurethral resection of the prostate), or any prior abdominal or pelvic surgery, most specifically for surgeries that may have included any form of lymphadenectomy or anatomic changes

• History of androgen deprivation therapy, any prior chemotherapy, or any prior radiation therapy to the pelvis

• Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes

• Subject in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered

• Subject has any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure

• The presence of medical conditions contraindicating general anesthesia or standard surgical approaches

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Intervention

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
• therapeutic lymphadenectomy
Undergo lymphadenectomy

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative detection of fluorescence in pelvic lymphatic tissue by near-infrared imaging technology on the da Vinci Surgical System following direct injection of ICG into the prostate	The ability to image lymph nodes prior to dissection will be estimated using means and standard errors for all observations as well as stratified by dose level and other relevant patient characteristics.	At the time of surgery
Secondary	Quality of fluorescence as detected by near-infrared technology on the da Vinci Surgical System of lymphatic tissue at varying safe doses of ICG	Analyzed using means and standard errors for continuous data and generating frequencies and percentages for categorical data. The Kruskal Wallis test and chi-square test (or Fisher's exact test as appropriate) will be used to detect any apparent differences in continuous and categorical data, respectively.	At the time of surgery
Secondary	Lymph node yield	Analyzed using means and standard errors for continuous data and generating frequencies and percentages for categorical data. The Kruskal Wallis test and chi-square test (or Fisher's exact test as appropriate) will be used to detect any apparent differences in continuous and categorical data, respectively.	At the time of surgery
Secondary	Number of positive lymph nodes (nodes that contain cancer on final pathology)	Analyzed using means and standard errors for continuous data and generating frequencies and percentages for categorical data. The Kruskal Wallis test and chi-square test (or Fisher's exact test as appropriate) will be used to detect any apparent differences in continuous and categorical data, respectively.	At the time of surgery