Tumor-Lymph Node Mapping

NCT ID: NCT07054944

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-30
• Study Completion Date: 2028-07-30

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

Pediatric Solid Tumors; Rhabdomyosarcoma; Sarcoma; Germ Cell Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Indocyanine Green (ICG) and KARL STORZ ICG Imaging System

Group Type: EXPERIMENTAL

ICG (Indocyanine Green)

Intervention Type: DIAGNOSTIC_TEST

Lymphatic mapping

Interventions

ICG (Indocyanine Green)

Lymphatic mapping

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Hafeez Abdel

Associate Professor - Department of Surgery, Pediatric Surgery (SMD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

STUDY00010277

Identifier Type: -

Identifier Source: org_study_id