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Sentinel Node Identification Using Gamma and Near-Infrared Imaging in TesticulAr MaLignancies (SIGNAL)

25 sierpnia 2026 zaktualizowane przez: N.N. Petrov National Medical Research Center of Oncology

Sentinel Node Identification Using Gamma Detection and Near-Infrared Fluorescence in Testicular Malignancies

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 procedure allows the disease stage to be determined more accurately by establishing whether cancer cells are present in the retroperitoneal lymph nodes. In some patients, surgery may potentially provide effective disease control without the need for subsequent radiotherapy or chemotherapy.

However, currently available imaging methods, including computed tomography (CT), cannot always accurately determine whether individual retroperitoneal lymph nodes contain cancer cells. Studies have shown that in some patients undergoing RPLND for suspected lymph node involvement, no cancer cells are subsequently found in the removed lymph nodes. Therefore, there is a need to develop more accurate methods for identifying the lymph nodes that are most likely to be the first sites of cancer spread.

This study investigates a method for identifying sentinel lymph nodes. Sentinel lymph nodes are the lymph nodes that first receive lymphatic drainage from the area of the primary tumor and may therefore be the first lymph nodes to which cancer cells spread.

In this study, two complementary methods will be used to identify sentinel lymph nodes. The first involves the administration of a small amount of a radiopharmaceutical containing technetium-99m (Tc-99m), followed by single-photon emission computed tomography combined with computed tomography (SPECT/CT). During surgery, these lymph nodes will also be identified using a special gamma-detection device.

The second method involves the use of indocyanine green (ICG), a fluorescent dye that allows the surgeon to visualize lymphatic drainage pathways and lymph nodes during surgery using near-infrared fluorescence imaging.

The combination of these two methods may allow more accurate identification of sentinel lymph nodes and provide a better understanding of lymphatic drainage from testicular tumors.

Participants are being invited to participate because the characteristics of their disease meet the eligibility criteria for this study.

The main purpose of the study is to determine how accurately and reliably sentinel lymph nodes can be identified in patients with testicular seminoma using a combination of radionuclide and fluorescence-guided techniques.

The information obtained from this study may help to develop a more individualized approach to the surgical treatment of patients with seminoma. In the future, accurate identification of sentinel lymph nodes may make it possible to reduce the extent of surgery in selected patients, potentially decreasing surgical trauma and the risk of postoperative complications. At the same time, accurate detection of cancer involvement in lymph nodes may help identify patients who require additional anticancer treatment, such as systemic chemotherapy.

It is important to understand that the approach being evaluated is investigational, and its advantages over currently established approaches have not yet been conclusively demonstrated. Therefore, participation in this study cannot guarantee any additional direct medical benefit to participants. However, the information obtained from participants may contribute to improving the diagnosis and treatment of patients with testicular seminoma in the future.

Participation in this study is entirely voluntary. Before making decision, participants will have the opportunity to discuss the purpose of the study, the study procedures, possible benefits and risks, and alternative treatment options with their doctor. Their decision not to participate, or to withdraw from the study at a later time, will not affect their right to receive appropriate medical care.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

60

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Rosja
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Rosja, 197758
        • Rekrutacyjny
        • FSBI "N.N. Petrov NMRC of oncology" MH of Russian Federation
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Alexander Nosov, PhD, Professor
        • Pod-śledczy:
          • Pavel Gorlin

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

## 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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
Standard-of-Care Group (Control Group)
Patients in the control group will undergo standard diagnostic and therapeutic management according to current clinical practice. Following radical inguinal orchiectomy and histopathological assessment, each patient's case will be reviewed by a multidisciplinary tumor board. Subsequent management, including active surveillance, systemic chemotherapy, radiotherapy, or other treatment when indicated, will be determined according to the pathological findings, clinical stage, and applicable clinical guidelines.
Procedura: Standard treatment: orchiectomy followed by drug therapy and, if necessary, retroperitoneal lymphadenectomy

Participants assigned to the control group will receive standard-of-care treatment in accordance with current clinical guidelines and institutional practice. Patients will initially undergo radical inguinal orchiectomy with subsequent pathology examination. Following confirmation of the diagnosis and assessment of the pathological and clinical stage, each patient's case will be reviewed by a tumor board to determine the appropriate further treatment strategy (observation, chemotherapy or surgery).

Depending on the clinical stage, pathological findings, prognostic factors, and tumor board decision, participants will receive standard care. Following systemic treatment, patients will undergo clinical and radiological response assessment. RPLND may be performed when clinically indicated based on residual retroperitoneal disease based on CT scans.
SLNB Group (Investigational Group)
Participants in the investigational group will undergo sentinel lymph node mapping using technetium-99m (Tc-99m) and indocyanine green (ICG). Preoperative lymphatic mapping will be performed using SPECT/CT following administration of the Tc-99m-labelled radiopharmaceutical. During minimally invasive surgery, sentinel lymph nodes will be identified using gamma detection and near-infrared fluorescence imaging following ICG administration. Identified sentinel lymph nodes will be removed and subjected to histopathological and immunohistochemical examination. Retroperitoneal lymph node dissection will be performed according to the study protocol and the patient's clinical stage. Radical inguinal orchiectomy will subsequently be performed, and all surgical specimens will undergo histopathological examination.
Procedura: sentinel lymph node mapping using technetium-99m (Tc-99m) and indocyanine green (ICG) with subsequent orchiectomy

Patients enrolled in the investigational group will undergo dual-tracer sentinel lymph node mapping and sentinel lymph node biopsy (SLNB) using a technetium-99m (Tc-99m)-labelled radiopharmaceutical and indocyanine green (ICG), followed by retroperitoneal lymph node dissection (RPLND) and radical inguinal orchiectomy.

Radiopharmaceutical Administration

Approximately 24 hours before surgery, patients will undergo administration of a Tc-99m-labelled colloidal radiopharmaceutical. Under ultrasound guidance using a high-frequency linear transducer, 0.2 mL of the radiopharmaceutical, with an activity of 740-860 MBq and a particle size of approximately 1,000 nm, will be injected beneath the tunica albuginea in the projection of the primary testicular tumor. The radiopharmaceutical will be prepared immediately before administration.

Preoperative SPECT/CT and Sentinel Lymph Node Mapping

Approximately 3 hours after radiopharmaceutical administration, radionuclide imaging of the lymphatic dr

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
3-year relapse-free survival
Ramy czasowe: 36 months
Relapse-free survival is defined as the time from the date of completion of the initial surgical treatment to the first documented disease relapse or death from any cause, whichever occurs first.
36 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
incidence of postoperative complications within 30 days after surgery
Ramy czasowe: 30 days
Postoperative complications will be recorded separately for the laparoscopic and robot-assisted surgical approaches. Complications will be classified according to the Clavien-Dindo classification, with major complications defined as Clavien-Dindo grade III or higher.
30 days
treatment de-escalation rate
Ramy czasowe: 52 weeks

The treatment de-escalation rate will be defined as the proportion of patients in the investigational group who, following primary minimally invasive sentinel lymph node biopsy (SLNB) and subsequent histopathological assessment, have no indication for adjuvant systemic anticancer therapy.

The indication for adjuvant systemic therapy will be determined based on the final pathological findings, disease stage, and multidisciplinary tumor board assessment in accordance with the applicable clinical guidelines.

The treatment de-escalation rate will be calculated as the number of patients who do not require adjuvant systemic anticancer therapy following the SLNB-based surgical treatment strategy divided by the total number of evaluable patients undergoing the investigational procedure.
52 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

N.N. Petrov National Medical Research Center of Oncology

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 kwietnia 2026

Zakończenie podstawowe (Szacowany)

1 kwietnia 2028

Ukończenie studiów (Szacowany)

1 kwietnia 2029

Daty rejestracji na studia

Pierwszy przesłany

17 sierpnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

20 sierpnia 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 sierpnia 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SIGNAL

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

De-identified individual participant data (IPD) may be shared upon reasonable request from qualified researchers, subject to approval by the study investigators and applicable institutional and ethical requirements. IPD will not be made publicly available due to patient confidentiality and data protection considerations. Any data sharing will be limited to information necessary to address the objectives of an approved research proposal.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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