Tumor-Lymph Node Mapping
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICG (Indocyanine Green).
- Who it may be relevant to
- Registry conditions: Pediatric Solid Tumors, Rhabdomyosarcoma, Sarcoma, Germ Cell Tumor. Basic parameters: 1 months — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
FEASIBILITY AND SAFETY OF INDOCYANINE GREEN (ICG) GUIDED SENTINEL LYMPH NODE MAPPING FOR PEDIATRIC SOLID TUMORS - T-LyM (Tumor-Lymph Node Mapping)
Overview
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.
Interventions
- Diagnostic test ICG (Indocyanine Green)
Lymphatic mapping
Primary outcome measures
- Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence [Time frame: Baseline]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- University of Rochester Medical Center — Rochester
Identifiers
NCT: NCT07054944 · STUDY00010277