Phase 3
Completed N=6
A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers
Pediatric Patients With Solid Tumors
Source: ClinicalTrials.gov NCT02910726 ↗
Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: % of Patients in Whom a Sentinel Lymph Node is Identified
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study is being done in patients that have tumors to find out how well sentinel lymph nodes (SLNs) can be found with a special dye called indocyanine green (ICG).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % of Patients in Whom a Sentinel Lymph Node is Identified |
— | — |
Eligibility Criteria
Inclusion Criteria
- Patients <30 years old with an extracoelomic solid tumor, diagnosis confirmed at the enrolling institution, requiring SLN biopsy
- Women of childbearing potential must have a negative pregnancy test (urine or blood) pre-operatively as per the standard hospital policy. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant.
- Patients who are cleared for surgery
Exclusion Criteria
- History of reaction to ICG, iodides, or technetium radiocolloid
- Intracoelomic primary tumors or tumors expected to drain to an intracoelomic SLN
- Patients with extensive prior surgery at the primary site or nodal basin expected to affect the lymphatic drainage
- Patients unwilling or unable to sign informed consent
- Women who are pregnant or breast-feeding
Data sourced from ClinicalTrials.gov (NCT02910726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.