Tumor-Lymph Node Mapping (T-LyM)

August 24, 2026 updated by: Hafeez Abdel, University of Rochester

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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.
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
Time Frame: During surgery (Day 0), based on intraoperative and postoperative pathology reports finalized within 7 days
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

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 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)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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