A Study Comparing Green Fluorescent Dye and Radioactive Dye for Sentinel Lymph Node Biopsy in Pediatric Cancers

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pediatric Patients With Solid Tumors

Treatments: Drug: indocyanine green (ICG); Procedure: Sentinel Lymph Node Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT02910726

16-1003

Details and patient eligibility

About

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).

Enrollment: 6 patients

Sex: All

Ages: Under 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

6 participants in 1 patient group

Sentinel Lymph Node Biopsy

Experimental group

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.

Treatment:

Drug: indocyanine green (ICG)

Procedure: Sentinel Lymph Node Biopsy