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NCT Number: NCT07054944

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.

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Key information

Conditions

Pediatric Solid Tumors Germ Cell Tumor Myosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Muscle Tissue Rhabdomyosarcoma Sarcoma

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location status: Recruiting

Location contact

Abdelhafeez Abdelhafeez

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ICG (Indocyanine Green)

Diagnostic Test

Lymphatic mapping

Primary outcomes

  1. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abdelhafeez Abdelhafeez, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Acronym: T-LyM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 8, 2025
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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