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Glowing dye could light up hidden lymph nodes in prostate cancer surgery

NCT ID NCT02119858

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether a dye called indocyanine green, viewed with near-infrared imaging, can help surgeons spot pelvic lymph nodes during robot-assisted prostate removal in men with stage II prostate cancer. The dye is injected into the prostate, and the imaging system is used during surgery to see if the lymph nodes light up. The goal is to improve the accuracy of lymph node removal, which may lead to better cancer staging and treatment planning.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
indocyanine green solution (a dye) used with near-infrared imaging during robot-assisted prostate surgery
What this could lead to
If it works, this could make lymph node removal during prostate cancer surgery more accurate, potentially improving staging and treatment decisions.
What could go wrong
This is a small early-phase trial, so results may not apply broadly. The dye or imaging might not clearly improve detection, and surgery carries standard risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Start date

Aug 2014

Finished

Feb 2018

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

More trials for these conditions

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