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โ† Trials
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Sentinel Node Identification Using Gamma and Near-Infrared Imaging in TesticulAr MaLignancies

Recruitingn/aAges 18 Years - 60 YearsMaleN.N. Petrov National Medical Research Center of Oโ€ฆ
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In plain words

What the trial is, and whether it could suit you

Testicular seminoma is a malignant tumor with a very high probability of cure. Current treatment approaches provide excellent long-term cancer outcomes. However, some standard treatments, including radiotherapy and platinum-based chemotherapy, may cause side effects both during treatment and many years after its completion. In the long term, these treatments may be associated with an increased risk of cardiovascular disease, metabolic disorders, and secondary malignancies. Because most patients with seminoma are successfully cured and have a long life expectancy, an important goal of modern cancer treatment is not only to achieve effective cancer control, but also to reduce the potential long-term adverse effects of treatment. One possible treatment approach is minimally invasive retroperitoneal lymph node dissection (RPLND), performed using laparoscopic or robot-assisted surgery. This

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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) โ‰ค5 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 ฮฒ-human chorionic gonadotropin (ฮฒ-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 โ‰ฅ2 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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What it tests

  • Standard treatment: orchiectomy followed by drug therapy and, if necessary, retroperitoneal lymphadenectomy
  • sentinel lymph node mapping using technetium-99m (Tc-99m) and indocyanine green (ICG) with subsequent orchiectomy
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Where

1 site
FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation
Saint Petersburg, Russia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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