Tumor-Lymph Node Mapping

N/ANot Yet RecruitingNCT07054944

University of Rochester10 enrolled

Overview

The purpose of this study is to assess the feasibility and safety of ICG-guided intraoperative lymphography for detecting sentinel lymph nodes (SLN) in pediatric patients with solid tumors who require retroperitoneal lymph node dissection/sampling. This trial is a single-site cross-sectional study. The injection of ICG directly into lymphatics draining the primary tumor will take place at the time of operation after the patient is under anesthesia.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pediatric Solid Tumors Rhabdomyosarcoma Sarcoma Germ Cell Tumor

Interventions

ICG (Indocyanine Green)DIAGNOSTIC_TEST

Lymphatic mapping

Eligibility

Sex: ALLMin age: 1 MonthMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Any pediatric patient (under the age of 18 years) being treated at the University of Rochester Medical Center, Department of Surgery. * Diagnosed with pediatric solid tumor * Scheduled to undergo lymph node sampling as part of their clinical management. Exclusion Criteria: * Subjects with a history of iodide allergies. * Inability or unwillingness of research participant or parent/legal guardian to give written informed consent. * Currently pregnant. * Infants under 650 grams. * Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence

Success is defined as the intraoperative identification of at least one fluorescent sentinel lymph node (SLN) after indocyanine green (ICG) injection using an Iridium system optimized for near-infrared detection. Visualization of the SLN indicates uptake of ICG within the lymphatic basin.

Time frame: Baseline

Central Contacts

Abdelhafeez Abdelhafeez, MD

CONTACT

Abdelhafeez_Abdelhafeez@URMC.Rochester.edu

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.