Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors

NCT06133699 | Unknown DMC

• 1 other identifier: 01112023-PITERLAND
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of sentinel lymph node biopsy in stage AI-IIA germ cell tumors (seminoma/nonseminoma). The main questions it aims to answer are:

• To evaluate relapse-free survival during the first two years after SLNB.
• To estimate the percentage of patients who did not require adjuvant treatment after primary endoscopic SLNB.
• Determine the microRNA expression profile in blood plasma, evaluate miRNAs as a potential prognostic and predictive factor in patients with testicular germ cell tumors.
• Assess the correlation between computed tomography and positive lymph nodes on examination. Participants will undergo:
• surgical treatment including orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye.
• 24 hours before the procedure, a radiopharmaceutical (RP) is injected into the spermatic cord, followed by SPECT to determine the regional sentinel lymph node(s).
• The level of microRNA will be examined before surgery and 10 days after surgery.

Conditions

Testicular Germ Cell Tumor

Keywords

testicular; Germ cell tumor; ICG; SLNB

Outcome Measures

Primary Outcomes (4)

• Relapse-free survival during the first two years after SLNB

  two years

• The percentage of patients who did not require adjuvant treatment after primary endoscopic SLNB

  two years

• Evaluation of miRNAs as a potential prognostic and prognostic factor in patients with testicular germ cell tumors.

  two years

• • Assess the correlation between computed tomography and positive lymph nodes on examination.

  two years

Secondary Outcomes (2)

• Сomplication rate

  two years

• All-cause mortality

  two years

Study Arms (1)

SLNB

EXPERIMENTAL

Procedure: Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye.; Diagnostic Test: Radiopharmaceutical administration (Technetium/methylene blue)

Interventions

Orchofuniculectomy with simultaneous laparoscopic biopsy of the sentinel lymph node using indocyanine green dye with/without methylene blue dye. PROCEDURE

Study participants will undergo orchofuniculectomy through an inguinal or laparoscopic approach. After completion of the orchofuniculectomy, indocyanine green (ICG) dye with or without methylene blue dye will be injected into the spermatic cord stump. Next step is detection with a gamma detector the sentinel lymph nodes and follow removing of one or more (up to 4) lymph nodes during laparoscopy. These lymph nodes will be sent for histological examination.

SLNB

Radiopharmaceutical administration (Technetium/methylene blue) DIAGNOSTIC_TEST

24 hours before surgery, a radiotracer (RP) will be injected into the spermatic cord followed by SPECT to identify the regional sentinel lymph node(s).

SLNB

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male person at least 18 years of age at the time of signing the informed consent form;
• Provisional diagnosis of testicular tumor with isolated retroperitoneal lymphadenopathy;
• Computed tomography data of the abdominal cavity and retroperitoneal space with axial visualization of lymphadenopathy (within 6 weeks before the planned date of surgical treatment): at least one lymph node larger than 1 cm.

You may not qualify if:

• Severe or uncontrolled concomitant chronic diseases or acute diseases;
• Any condition that, in the opinion of the physician, may limit compliance with the study;
• Poor general condition (ECOG \> 2, KPS \< 70);
• Refusal of the patient to comply with the study procedures or refusal of the patient to continue participating in the study;
• Development of diseases or conditions that prevent the patient's continued participation in the study;
• AFP level is higher than reference values and / or b-hCG \> 100 mIU/ml;
• Presence of a second malignant disease;
• History of systemic antitumor therapy and/or radiotherapy;
• Inadequate bone marrow, liver, kidney function: (Neutrophils \< 1.5 x 10\^9/l, Platelets \< 100 x 10\^9/l, ALT \> 3 x ULN, AST \> 3 x ULN, Total bilirubin \> 1.5 xULN, GFR \<35 ml/min)

Sponsors & Collaborators

• N.N. Petrov National Medical Research Center of Oncology: lead

Study Sites (1)

Federal State Budgetary Institute N.N. Petrov National Medical Research Center of Oncology Ministry of Health of the Russian Federation

Saint Petersburg, 197758, Russia

RECRUITING

MeSH Terms

Conditions

Testicular Germ Cell Tumor; Neoplasms, Germ Cell and Embryonal

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 15, 2023
• Study Start: November 8, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-11

Locations

RU (1)