Tumor-Lymph Node Mapping

NCT07054944 | Recruiting DMC FDA Drug FDA Device

• 1 other identifier: STUDY00010277
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhabdomyosarcoma; Sarcoma; Pediatric Solid Tumors; Germ Cell Tumor

Keywords

PEDIATRIC CANCER

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Indocyanine Green (ICG) and KARL STORZ ICG Imaging System

Diagnostic Test: ICG (Indocyanine Green)

Interventions

ICG (Indocyanine Green) DIAGNOSTIC_TEST

Lymphatic mapping

Indocyanine Green (ICG) and KARL STORZ ICG Imaging System

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Rhabdomyosarcoma; Sarcoma; Neoplasms, Germ Cell and Embryonal; Neoplasms

Condition Hierarchy (Ancestors)

Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Central Study Contacts

Abdelhafeez Abdelhafeez, MD

CONTACT

Abdelhafeez_Abdelhafeez@URMC.Rochester.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Surgery, Pediatric Surgery (SMD)

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 8, 2025
• Study Start: April 13, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)