Tumor-Lymph Node Mapping

NCT07054944 — Not yet recruiting, 10 participants, University of Rochester

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

Registry	NCT07054944, acronym T-LyM
Status	Not yet recruiting
Study type	Observational
Enrollment	10 (Estimated)
Sponsor	University of Rochester (Other)
Conditions	Pediatric Solid Tumors, Rhabdomyosarcoma, Sarcoma, Germ Cell Tumor
Interventions	ICG (Indocyanine Green) (Diagnostic test)
Dates	start 2026-12-13 (estimated), primary completion 2028-07-30 (estimated), completion 2028-07-30 (estimated), first posted 2025-07-08, last updated 2026-08-26
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Indocyanine Green (ICG) and KARL STORZ ICG Imaging System		Diagnostic Test: ICG (Indocyanine Green)

ICG (Indocyanine Green) (Diagnostic test): Lymphatic mapping

+Outcome measures

Primary outcomes

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.

Other outcomes

Accuracy of SLN Biopsy as Measured by Concordance Between SLN Pathology and Nodal Basin Pathology [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.

+Eligibility

Sex: All, ages: 1 Month to 17 Years

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)

Facility	City	Country	Status
University of Rochester Medical Center	Rochester, New York	United States