Clinical trial · Observational
Tumor-Lymph Node Mapping
FEASIBILITY AND SAFETY OF INDOCYANINE GREEN (ICG) GUIDED SENTINEL LYMPH NODE MAPPING FOR PEDIATRIC SOLID TUMORS - T-LyM (Tumor-Lymph Node Mapping)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Pediatric Solid Tumors | Childhood Solid Neoplasm | CURATED_BROADER | 0.80 |
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG (Indocyanine Green) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Indocyanine Green (ICG) and KARL STORZ ICG Imaging System
- interventionNames
- Diagnostic Test: ICG (Indocyanine Green)
Primary outcomes (1)
- measure
- Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence
- timeFrame
- Baseline
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 17 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available