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

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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