Using a dye to help find lymph nodes in children with solid tumors
Feasibility and Safety of Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
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 |
| Enrollment | 25 (estimated) |
| Ages | N/A to 20 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT05645523 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and young adults under 21 years with suspected Wilms tumor or para-testicular rhabdomyosarcoma requiring lymph node dissection.
Not a fit: Patients with a history of iodide allergies or extensive prior surgery affecting lymphatic drainage may not benefit from this study.
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 performed: Other studies using ICG for sentinel lymph node mapping have shown promising results, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Chicago, Illinois and 2 other locations
- 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
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.