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

NCT02119858 | Completed Phase 1 DMC

• 2 other identifiers: 14015NCI-2014-00711
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of fluorescence as detected by near-infrared technology on the da Vinci Surgical System of lymphatic tissue at varying safe doses of ICG

  At the time of surgery

• Lymph node yield

  At the time of surgery

• Number of positive lymph nodes (nodes that contain cancer on final pathology)

  At the time of surgery

Study Arms (1)

Diagnostic (ICG, diffuse optical imaging, surgery)

EXPERIMENTAL

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.

Drug: indocyanine green solution; Other: diffuse optical imaging; Procedure: robot-assisted laparoscopic surgery; Procedure: therapeutic lymphadenectomy

Interventions

indocyanine green solution DRUG

Given transperineally

Also known as: IC-GREEN, ICG solution

Diagnostic (ICG, diffuse optical imaging, surgery)

diffuse optical imaging OTHER

Undergo near infrared fluorescence imaging

Also known as: diffuse optical spectroscopy, diffuse optical tomography, DOI, near infrared optical tomography

Diagnostic (ICG, diffuse optical imaging, surgery)

robot-assisted laparoscopic surgery PROCEDURE

Undergo robot-assisted laparoscopic radical prostatectomy

Diagnostic (ICG, diffuse optical imaging, surgery)

therapeutic lymphadenectomy PROCEDURE

Undergo lymphadenectomy

Diagnostic (ICG, diffuse optical imaging, surgery)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bertram Yuh

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 22, 2014
• Study Start: July 25, 2014
• Primary Completion: February 7, 2018
• Study Completion: February 7, 2018
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

US (1)