NCT02509598

A Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping

A Prospective, Open-Label, Multicenter Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cardinal Health 414, LLC · Industry
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

Open label, non-randomized, multi-center, within-subject comparative study to evaluate the tolerability and the diagnostic utility of Lymphoseek with optional comparison to VBD in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from neonatal through 17 years.

Conditions

• Rhabdomyosarcoma
• Melanoma

Interventions

Type	Name	Description
DRUG	Tc99m tilmanocept	A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery
DRUG	Vital Blue Dye (optional)	A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care).
PROCEDURE	Lymph Node Mapping	Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Timeline

• Start date: 2015-08-01
• Primary completion: 2019-03-06
• Completion: 2019-03-06
• First posted: 2015-07-28
• Last updated: 2024-06-28
• Results posted: 2024-06-28

Locations

6 sites across 1 country: United States