Tumor-Lymph Node Mapping

Not Applicable

Not yet recruiting

• Conditions: Pediatric Solid Tumors; Rhabdomyosarcoma; Sarcoma; Germ Cell Tumor

• Registration Number: NCT07054944
• Lead Sponsor: University of Rochester

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-08
• Last Update Posted: 2025-07-08
• Study Start: 2025-07-30
• Primary Completion: 2028-07-30
• Study Completion: 2028-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence	Baseline	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.