Tumor-Lymph Node Mapping (T-LyM)

University of Rochester

Status and phase

Not yet enrolling

Phase 1

Conditions

Germ Cell Tumor

Sarcoma

Rhabdomyosarcoma

Pediatric Solid Tumors

Treatments

Diagnostic Test: ICG (Indocyanine Green)

Study type

Interventional

Funder types

Other

Identifiers

NCT07054944

STUDY00010277

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

1 month to 17 years old

Volunteers

No Healthy Volunteers

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.