Sentinel Node Identification in Testicular Cancer Using Gamma and Near-Infrared Imaging

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational effort explores the use of gamma detection and near-infrared imaging to identify sentinel lymph nodes in patients with suspected testicular germ cell tumors. Participants undergo standard orchiectomy with additional sentinel node mapping using Technetium-99m and indocyanine green, followed by assessment to determine nodal status. The goal is to improve staging accuracy and potentially allow less extensive treatment while preserving long-term health. The study focuses on adults with small primary tumors and no distant metastasis, enrolled at a single Russian oncology center.

Why it matters

Who can join: the full rules

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.

Where it's running

• FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation
  Saint Petersburg, Sankt-Peterburg, Russia Recruiting

Study contacts

• Study coordinator: Mariya Berkut, PhD
• Email: berkutv91@gmail.com
• Phone: + 7 9312870497

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.