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

PHASE2CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

March 6, 2019

Study Completion Date

March 6, 2019

Conditions
RhabdomyosarcomaMelanoma
Interventions
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

Trial Locations (6)

15224

Children's Hospital of Pittsburgh, Pittsburgh

32207

Nemours Children's Specialty Care, Jacksonville

32827

Nemours Children's Hopsital, Orlando

43205

Nationwide Children's Hospital, Columbus

45229

Children's Hospital Medical Center, Cincinnati

77030

The University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
lead

Cardinal Health 414, LLC

INDUSTRY

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 | Biotech Hunter | Biotech Hunter