Tumor-Lymph Node Mapping (T-LyM)

FEASIBILITY AND SAFETY OF INDOCYANINE GREEN (ICG) GUIDED SENTINEL LYMPH NODE MAPPING FOR PEDIATRIC SOLID TUMORS - T-LyM (Tumor-Lymph Node Mapping)

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 Overview

• Status: Recruiting
• Conditions: Sarcoma; Rhabdomyosarcoma; Germ Cell Tumor; Pediatric Solid Tumors
• Intervention / Treatment: Diagnostic test: ICG (Indocyanine Green)

• Study Type: Observational
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Abdelhafeez Abdelhafeez, MD; Email: Abdelhafeez_Abdelhafeez@URMC.Rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
      • Contact: Abdelhafeez Abdelhafeez; Email: Abdelhafeez_Abdelhafeez@URMC.Rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged 1 month to 17 years with diagnosed solid tumors who are receiving care at the University of Rochester Medical Center (URMC), Department of Surgery. Eligible participants are those scheduled to undergo lymph node sampling as part of standard clinical management. Participants will be identified through pediatric oncology, pediatric surgery, and tumor board evaluations.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Indocyanine Green (ICG) and KARL STORZ ICG Imaging System	Diagnostic test: ICG (Indocyanine Green); Lymphatic mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of SLN Biopsy as Measured by Concordance Between SLN Pathology and Nodal Basin Pathology	Accuracy is assessed by comparing the pathology results of the SLN and the retroperitoneal lymph node basin dissection. True positives and true negatives are defined as SLN and nodal basin showing matching tumor status (both positive or both negative). Discordant finding is defined as tumor basin positive for tumor while SLN is negative for tumor. Discordant findings are considered false negatives. A tumor positive SLN in a tumor negative nodal basin is not considered discordant or false positive because sentinel may be the first and only tumor involved lymph node within the nodal basin.	During surgery (Day 0), based on intraoperative and postoperative pathology reports finalized within 7 days

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Estimated): April 13, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: July 2, 2025
• First Posted (Actual): July 8, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PEDIATRIC CANCER
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Neoplasms, Muscle Tissue; Myosarcoma; Neoplasms; Sarcoma; Neoplasms, Germ Cell and Embryonal; Rhabdomyosarcoma
• Other Study ID Numbers: STUDY00010277

Drug and device information, study documents

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