Clinical trial · Interventional
A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers
Non-inferiority Study of Intra-operative Indocyanine Green Fluorescent Dye Versus Technetium Lymphoscintigraphy for Sentinel Lymph Node Biopsy in Pediatric Malignancies
NCT02910726CI-TRIAL-00061253completedPhase 2 / Phase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Patients With Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| indocyanine green (ICG) | Drug | — | UNRESOLVED |
| Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentinel Lymph Node Biopsy
- description
- This is a single-center clinical trial to evaluate non-inferiority of ICG-guided SLN biopsy compared with the gold standard TcL-guided SLN biopsy in pediatric patients with solid tumors. Each patient will undergo TcL, consistent with the standard of care, but the surgeon will be blinded to the results preoperatively. Intraoperatively, ICG injection and transdermal lymphography will be used to identify the draining nodal basin and the position of the sentinel nodes. ICG transdermal lymphography will be considered successful if SLNs can be visualized on near-infrared imaging. After the transdermal lymphography results have been recorded, the surgeon will be unblinded to the TcL mapping.
- interventionNames
- Procedure: Sentinel Lymph Node Biopsy
- Drug: indocyanine green (ICG)
Primary outcomes (1)
- measure
- % of Patients in Whom a Sentinel Lymph Node is Identified
- timeFrame
- 1 year
- description
- These percentages will be compared using a non-inferiority comparison for matched pair data.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.