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

NCT ID: NCT02119858

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-25
• Study Completion Date: 2018-02-07

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.

Conditions

Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (ICG, diffuse optical imaging, surgery)

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.

Group Type: EXPERIMENTAL

indocyanine green solution

Intervention Type: DRUG

Given transperineally

diffuse optical imaging

Intervention Type: OTHER

Undergo near infrared fluorescence imaging

robot-assisted laparoscopic surgery

Intervention Type: PROCEDURE

Undergo robot-assisted laparoscopic radical prostatectomy

therapeutic lymphadenectomy

Intervention Type: PROCEDURE

Undergo lymphadenectomy

Interventions

indocyanine green solution

Given transperineally

Intervention Type: DRUG

diffuse optical imaging

Undergo near infrared fluorescence imaging

Intervention Type: OTHER

robot-assisted laparoscopic surgery

Undergo robot-assisted laparoscopic radical prostatectomy

Intervention Type: PROCEDURE

therapeutic lymphadenectomy

Undergo lymphadenectomy

Intervention Type: PROCEDURE

Other Intervention Names

IC-GREEN; ICG solution; diffuse optical spectroscopy; diffuse optical tomography; DOI; near infrared optical tomography

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertram Yuh

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2014-00711

Identifier Type: REGISTRY

Identifier Source: secondary_id

14015

Identifier Type: OTHER

Identifier Source: secondary_id

14015

Identifier Type: -

Identifier Source: org_study_id