Germ Cell Tumor, Pediatric Solid Tumors, Rhabdomyosarcoma, Sarcoma
Conditions
Keywords
PEDIATRIC CANCER
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.
Interventions
DIAGNOSTIC_TESTICG (Indocyanine Green)
Lymphatic mapping
Sponsors
University of Rochester
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients with Successful Sentinel Lymph Node (SLN) Detection Using ICG Fluorescence | Baseline | 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. |
Countries
United States
Contacts
CONTACTAbdelhafeez Abdelhafeez, MD
Outcome results
None listed