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

NARecruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

November 8, 2023

Primary Completion Date

November 30, 2024

Study Completion Date

November 30, 2025

Conditions
Testicular Germ Cell Tumor
Interventions
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).

Trial Locations (1)

197758

RECRUITING

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

All Listed Sponsors
lead

N.N. Petrov National Medical Research Center of Oncology

OTHER