Stage IIA Prostate CancerPhase 1NCT02119858
Diffuse Optical Imaging With Indocyanine Green Solution in Imaging Pelvic Lymph Nodes in Patients With Stage II Prostate Cancer Undergoing Surgery
A Phase 1 study testing indocyanine green solution, diffuse optical imaging and robot-assisted laparoscopic surgery in people with Stage IIA Prostate Cancer and Stage IIB Prostate Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Stage IIA Prostate Cancer, Stage IIB Prostate Cancer
- What is being tested?
- indocyanine green solution, diffuse optical imaging and robot-assisted laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2014to 7 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- indocyanine green solution, diffuse optical imaging, robot-assisted laparoscopic surgery, therapeutic lymphadenectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
indocyanine green solutionDrug
Also called IC-GREEN, ICG solution
Given transperineally
diffuse optical imagingOther
Also called diffuse optical spectroscopy, diffuse optical tomography, DOI, near infrared optical tomography
Undergo near infrared fluorescence imaging
robot-assisted laparoscopic surgeryProcedure or surgery
Undergo robot-assisted laparoscopic radical prostatectomy
therapeutic lymphadenectomyProcedure or surgery
Undergo lymphadenectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: indocyanine green solution; Other: diffuse optical imaging; Procedure: robot-assisted laparoscopic surgery; Procedure: therapeutic lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: At the time of surgery
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.
Measured: At the time of surgery
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.
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study start22 Aug 2014
- Primary completion7 Feb 2018
- Study completion7 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIA Prostate CancerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bertram Yuh, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119858
- Sponsor's protocol ID
- 14015
- Other IDs
- NCI-2014-00711, 14015
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2014
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02119858
- Acronym / sponsor ID
- 14015
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Aug 2014
- Primary completion
- 7 Feb 2018 (actual)
- Study completion
- 7 Feb 2018 (actual)
- First posted
- 22 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (ICG, diffuse optical imaging, surgery) | Experimental | Drug: indocyanine green solution, Other: diffuse optical imaging, Procedure: robot-assisted laparoscopic surgery, Procedure: therapeutic lymphadenectomyPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stage 2, intermediate to high risk (per D'Amico criteria) localized prostate cancer with a prostate gland size =< 100 grams
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| indocyanine green solutionAlso: IC-GREEN, ICG solutionGiven transperineally | Drug | Diagnostic (ICG, diffuse optical imaging, surgery) |
| diffuse optical imagingAlso: diffuse optical spectroscopy, diffuse optical tomography, DOI, near infrared optical tomographyUndergo near infrared fluorescence imaging | Other | Diagnostic (ICG, diffuse optical imaging, surgery) |
| robot-assisted laparoscopic surgeryUndergo robot-assisted laparoscopic radical prostatectomy | Procedure or surgery | Diagnostic (ICG, diffuse optical imaging, surgery) |
| therapeutic lymphadenectomyUndergo lymphadenectomy | Procedure or surgery | Diagnostic (ICG, diffuse optical imaging, surgery) |
Primary outcome
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
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertram Yuh principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing indocyanine green solution, diffuse optical imaging and robot-assisted laparoscopic surgery in people with Stage IIA Prostate Cancer and Stage IIB Prostate Cancer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.