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Can a glowing dye and a gamma probe spare testicular cancer patients from chemo?

NCT ID NCT07777887

Disease control Sponsor: N.N. Petrov National Medical Research Center of Oncology Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 20, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This trial tests whether combining two imaging techniques—a radioactive tracer and a fluorescent dye—can better identify sentinel lymph nodes in men with testicular seminoma. The goal is to see if this approach can accurately show whether cancer has spread, potentially allowing some patients to avoid chemotherapy or radiation and their long-term side effects. The study involves men with early-stage testicular tumors who are undergoing standard surgery, and it compares the new detection method to usual care.

What this could mean

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

Active substance
A combination of a radiopharmaceutical (technetium-99m) and a fluorescent dye (indocyanine green) used to identify sentinel lymph nodes during surgery.
What this could lead to
If successful, this approach could allow more precise, less invasive surgery for testicular cancer, potentially sparing some patients from chemotherapy or radiation and reducing long-term side effects.
What could go wrong
This is an early-stage, investigational technique. It may not reliably identify all affected lymph nodes, and its benefits over standard care are not yet proven. There are also risks from the surgical procedure and the injected substances.

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.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2029

An estimate. End dates often move.

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.

Who is studied

\## Study Population Description The study population will consist of \*\*adult male patients (≥18 years of age) with a primary testicular tumor suspicious for a testicular germ cell tumor (TGCT)\*\* who are candidates for radical inguinal orchiectomy (orchifuniculectomy). Eligible patients will have a primary testicular tumor with a maximum diameter of \*\*≤5 cm\*\*, no evidence of distant metastatic disease (\*\*cM0\*\*), and limited or no radiologically detectable retroperitoneal lymph node involvement. The study will include patients with \*\*cN0 disease and eligible serum tumor marker levels\*\*, as well as selected patients with \*\*cN1-cN2 disease\*\* and limited retroperitoneal lymph node involvement, in accordance with the predefined eligibility criteria. Patients with distant metastatic disease, advanced retroperitoneal lymph node involvement, S2-S3 serum tumor marker levels, previous specific anticancer treatment for a testicular germ cell tumor, or contraindications.

Ages

18 to 60 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: * Presence of a primary testicular tumor suspicious for a testicular germ cell tumor (TGCT) and considered an indication for radical inguinal orchiectomy (orchifuniculectomy); * Male gender; * Maximum diameter of the primary testicular tumor (cT) ≤5 cm; * One of the following clinical nodal and serum tumor marker criteria: * \- cN0 disease with serum tumor markers corresponding to S1 category: alpha-fetoprotein (AFP) 0-5.8 IU/mL and β-human chorionic gonadotropin (β-hCG) \>2.5 and \<1,000 IU/mL; or * -cN1-cN2 disease, with no more than two radiologically suspicious retroperitoneal lymph nodes, and serum tumor markers corresponding to S0-S1 category; * No evidence of distant metastatic disease (cM0). * Patient refusal to undergo adjuvant anticancer treatment (chemotherapy or radiotherapy) following radical inguinal orchiectomy, or unwillingness/inability to undergo close active surveillance. * Ability to understand the study requirements and provision of written voluntary informed consent prior to participation in the study. Exclusion Criteria: * Maximum diameter of the primary testicular tumor (cT) \>5 cm; * Presence of distant metastatic disease (cM1); * Serum tumor marker levels corresponding to S2-S3 category. * Clinical stage cN1 with ≥2 retroperitoneal lymph nodes suspicious for metastatic involvement; * Clinical stage cN3 disease; * Any previous specific anticancer treatment for a testicular germ cell tumor, including systemic chemotherapy, radiotherapy, or prior retroperitoneal surgery for testicular cancer; * Presence of any contraindication to minimally invasive surgery, administration of indocyanine green (ICG), or administration of the technetium-99m (Tc-99m)-labelled radiopharmaceutical used for sentinel lymph node mapping.

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Conditions

The condition(s) this trial relates to.

Neoplasms, Germ Cell and Embryonal seminoma testicular germ cell tumor

As listed by the trial registrant

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

Germ cell tumor of testis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation

    RECRUITING

    Saint Petersburg, Sankt-Peterburg, 197758, Russia

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