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

A Prospective, Single-center, Clinical Trial to Evaluate the Efficacy of Sentinel Lymph Node Biopsy in Stage AI-IIA Germ Cell Tumors (Seminoma/Nonseminoma)(PITERLAND).

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.

Study Overview

• Status: Recruiting
• Conditions: Testicular Germ Cell Tumor
• Intervention / Treatment: 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)

Detailed Description

Research Design This study is a prospective, single-center, non-randomized study evaluating the role of primary endoscopic SLNB on progression-free survival in patients with stage I-II germ cell seminoma/non-seminoma tumor without adjuvant treatment. Additionally, the study will determine the prognostic value of miRNAs as a noninvasive marker in clinical practice.

This study plans to recruit 44 male patients with a preliminary diagnosis of testicular tumor.

Patients who meet the inclusion/exclusion criteria will undergo surgical treatment including orchofuniculectomy with a simultaneous assessment and biopsy of the sentinel retroperitoneal lymph node.

The first stage of treatment Pre-operative preparation At the preoperative stage, it is planned to perform 3D modeling of computed tomography slices to visualize tumor conglomerates and vascular topography. A map of lymph node dissection zones will also be compiled. The anatomical boundaries of lymph node dissection are the aorta, the inferior vena cava, the iliac vessels, their bifurcation zones, the renal and mesenteric vessels. Due to the distribution of lymph nodes into cohorts (from 1 to 9 in each case), further histological examination of the surgical material will assess the completeness of the performed lymph node dissection.

Radiopharmaceutical administration (Technetium/methylene blue) 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).

Orchofuniculectomy 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.

Second stage of treatment Laparoscopic access and port placement

Under general anesthesia, with the patient in the supine position with arms extended along the body and legs spread apart, after processing the surgical field, laparoscopic ports will be installed under sterile conditions as follows:

• In the pubic region, 1 cm below the navel, an optical trocar is installed according to the Hasson technique (pneumoperitoneum (P=14 mmHg).
• Installation of trocars in the right iliac region, in the left iliac region and above the pubic symphysis (5, 5 and 11 mm, respectively).

The patient is then placed in the Trendelenburg position. BSLU Next, in the operating room, the surgeon will use a gamma detector to determine the location of the sentinel lymph nodes, followed by removal of one or more (up to 4) lymph nodes from which the signal is received. These lymph nodes will be sent for histological examination.

The results of the work performed will present indicators of relapse-free survival after SLNB, as well as functional outcomes, such as postoperative complications, duration of hospital treatment, frequency of retrograde ejaculation in patients with stage IA-IIA testicular germ cell tumor. The data obtained will allow optimizing the selection of patients for surgical treatment, as well as identifying prognostic factors for the adjuvant stage of therapy.

Additionally, as part of the work, it is planned to study the expression profile of microRNAs in blood plasma, with subsequent assessment as a potential prognostic and predictive factor in patients with germ cell tumors. For this purpose, blood will be drawn from patients before surgery and 10 days after surgery.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Saint-Petersburg, Russian Federation, 197758
    • Recruiting
    • Federal State Budgetary Institute N.N. Petrov National Medical Research Center of Oncology Ministry of Health of the Russian Federation
    • Contact: Eldar Mamizhev, PhD (Med.), Oncologist; Phone Number: +79217696923; Email: mamijev@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SLNB

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Сomplication rate	two years
All-cause mortality	two years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ICG; Germ cell tumor; testicular; SLNB
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue; Radiopharmaceuticals
• Other Study ID Numbers: 01112023-PITERLAND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No