Overview

This trial is active, not recruiting.

Conditions stage iia prostate cancer, stage iib prostate cancer
Treatments indocyanine green solution, diffuse optical imaging, robot-assisted laparoscopic surgery, therapeutic lymphadenectomy
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date July 2014
End date January 2017
Trial size 20 participants
Trial identifier NCT02119858, 14015, NCI-2014-00711

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(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.
indocyanine green solution IC-GREEN
Given transperineally
diffuse optical imaging diffuse optical spectroscopy
Undergo near infrared fluorescence imaging
robot-assisted laparoscopic surgery
Undergo robot-assisted laparoscopic radical prostatectomy
therapeutic lymphadenectomy
Undergo lymphadenectomy

Primary Outcomes

Measure
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
time frame: At the time of surgery

Secondary Outcomes

Measure
Quality of fluorescence as detected by near-infrared technology on the da Vinci Surgical System of lymphatic tissue at varying safe doses of ICG
time frame: At the time of surgery
Lymph node yield
time frame: At the time of surgery
Number of positive lymph nodes (nodes that contain cancer on final pathology)
time frame: At the time of surgery

Eligibility Criteria

Male participants from 18 years up to 80 years old.

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

Additional Information

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
Principal investigator Bertram Yuh
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.