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

What Was Tested

In this not phased trial, researchers set out to test Methylene blue (non-peptide stack partner).

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.

It had 1 arm (groups): SLNB (experimental).

The registry classes the interventions as diagnostic test and procedure.

More on the Plan

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.

Who Took Part

Enrollment: 44 planned participants were the target.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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;.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: 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);.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-11-08 with completion listed for 2024-11-30.

It ran at 1 site in Russia.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Relapse-free survival during the first two years after SLNB (time frame: two years). The percentage of patients who did not require adjuvant treatment after primary endoscopic SLNB (time frame: two years). Evaluation of miRNAs as a potential prognostic and prognostic factor in patients with testicular germ cell tumors (time frame: two years).

It also tracked 2 secondary outcomes, for example Сomplication rate and All-cause mortality.

What This Means in Plain Language

Put simply, this is a not phased trial of Methylene blue (non-peptide stack partner) in 44 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.