Using a dye to help find lymph nodes in children with solid tumors
Official title: Feasibility and Safety of Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
Run by St. Jude Children's Research Hospital · NCT05645523 · Data updated 2026-11-12
This study is testing a special dye to see if it can help doctors find lymph nodes in children with solid tumors during surgery, making it easier to plan their treatment.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | Any age to 20 Years |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Status | Recruiting |
| Started | October 24, 2023 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 30, 2026 |
| Trial ID | NCT05645523 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children and young adults under 21 years with suspected Wilms tumor or para-testicular rhabdomyosarcoma requiring lymph node dissection.
✕Probably not a fit
Patients with a history of iodide allergies or extensive prior surgery affecting lymphatic drainage may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety and effectiveness of Indocyanine Green (ICG) dye in guiding surgeons during the removal of lymph nodes in pediatric patients with visceral solid tumors. The dye helps identify lymph nodes that may be affected by cancer, allowing for better staging and treatment planning. Participants will receive the dye during surgery, and the procedure will be documented through images and videos. After surgery, patients will be monitored for any adverse effects related to the dye for up to 24 hours.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and cancer staging for pediatric patients with solid tumors.
How similar studies have gone: Other studies using ICG for sentinel lymph node mapping have shown promising results, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient under the age of 21 years with visceral pediatric solid tumor suspected to be Wilms tumor or para-testicular rhabdomyosarcoma requiring retroperitoneal lymph node dissection. Exclusion Criteria: * Subjects with a history of iodide allergies. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. * Pregnant female. * Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage.
Where it's running
-
Lurie Children's Hospital
Chicago, Illinois, United States Recruiting -
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States Recruiting -
St. Jude Children's Research Hospital
Memphis, Tennessee, United States Recruiting
Study contacts
- Principal investigator: Andrew Davidoff, MD — St. Jude Children's Research Hospital
- Study coordinator: Andrew Davidoff, MD
- Email: referralinfo@stjude.org
- Phone: 888-226-4343
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.