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

Primary Purpose

Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
indocyanine green solution
diffuse optical imaging
robot-assisted laparoscopic surgery
therapeutic lymphadenectomy
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stage IIA Prostate Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (ICG, diffuse optical imaging, surgery)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 9, 2014
Last Updated
February 19, 2018
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02119858
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 25, 2014 (undefined)
Primary Completion Date
February 7, 2018 (Actual)
Study Completion Date
February 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (ICG, diffuse optical imaging, surgery)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
indocyanine green solution
Other Intervention Name(s)
IC-GREEN, ICG solution
Intervention Description
Given transperineally
Intervention Type
Other
Intervention Name(s)
diffuse optical imaging
Other Intervention Name(s)
diffuse optical spectroscopy, diffuse optical tomography, DOI, near infrared optical tomography
Intervention Description
Undergo near infrared fluorescence imaging
Intervention Type
Procedure
Intervention Name(s)
robot-assisted laparoscopic surgery
Intervention Description
Undergo robot-assisted laparoscopic radical prostatectomy
Intervention Type
Procedure
Intervention Name(s)
therapeutic lymphadenectomy
Intervention Description
Undergo lymphadenectomy
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
At the time of surgery
Secondary Outcome Measure Information:
Title
Quality of fluorescence as detected by near-infrared technology on the da Vinci Surgical System of lymphatic tissue at varying safe doses of ICG
Description
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.
Time Frame
At the time of surgery
Title
Lymph node yield
Description
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.
Time Frame
At the time of surgery
Title
Number of positive lymph nodes (nodes that contain cancer on final pathology)
Description
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.
Time Frame
At the time of surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertram Yuh
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

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

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