Clinical trial NCT02119858: Diffuse Optical Imaging With Indocyanine Green Solution in Imaging Pelvic Lymph Nodes in Patients With Stage II Prostate Cancer Undergoing Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-04-22
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

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
timeFrame: 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
timeFrame: At the time of surgery
measure: Lymph node yield
timeFrame: At the time of surgery
measure: Number of positive lymph nodes (nodes that contain cancer on final pathology)
timeFrame: At the time of surgery
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Bertram Yuh
role: PRINCIPAL_INVESTIGATOR
References: