Mapping tumor lymph node drainage in children
FEASIBILITY AND SAFETY OF INDOCYANINE GREEN (ICG) GUIDED SENTINEL LYMPH NODE MAPPING FOR PEDIATRIC SOLID TUMORS - T-LyM (Tumor-Lymph Node Mapping)
This will try using a safe fluorescent dye (indocyanine green) during surgery to find sentinel lymph nodes in children with solid tumors who need retroperitoneal lymph node sampling.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 1 Month to 17 Years |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT07054944 on ClinicalTrials.gov |
What this trial studies
This single-site, observational cross-sectional study will inject indocyanine green (ICG) into lymphatics draining the primary tumor while the child is under anesthesia and undergoing planned surgery. Surgeons will use intraoperative fluorescence imaging to visualize and locate sentinel lymph nodes in the retroperitoneal basin. The study focuses on feasibility and safety outcomes, including the rate of sentinel node identification and any ICG-related adverse events. No additional procedures beyond the planned lymph node sampling and the ICG injection are required.
Who should consider this trial
Good fit: Children under 18 years with a pediatric solid tumor who are scheduled for retroperitoneal lymph node dissection or sampling at the University of Rochester and who do not have iodide allergy are ideal candidates.
Not a fit: Patients with prior extensive surgery that alters lymphatic drainage, those with iodide allergies, very small infants under 650 grams, pregnant patients, or those not undergoing lymph node sampling are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could help surgeons identify sentinel lymph nodes more accurately and potentially reduce the extent of lymph node surgery and its side effects.
How similar studies have performed: ICG-guided sentinel node mapping has been successful in adult cancers and some pediatric settings, but its use for retroperitoneal nodes in pediatric solid tumors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, New York
- University of Rochester Medical Center — Rochester, New York, United States (Recruiting)
Study contacts
- Study coordinator: Abdelhafeez Abdelhafeez, MD
- Email: Abdelhafeez_Abdelhafeez@URMC.Rochester.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.