NCT00186953

Determination of a Safe Dose of Optison in Pediatric Patients With Solid Tumors

Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves to create pictures, allowing doctors and other medical professionals to "see" inside the body. Researchers are studying a contrast agent (like a dye) called Optison™. St. Jude Children's Research Hospital researchers want to learn the best and safest dose of this ultrasound "dye."

Conditions

• Abdominal Neoplasms
• Pelvic Neoplasms

Interventions

Type	Name	Description
DRUG	Optison	Intervention description: Based on recommendation by the FDA, we began with a dose of 0.125ml/m\^2 and escalated at 0.15 ml/m\^2 increments, to 0.275 ml/m\^2 and 0.425ml/m\^2 and 0.500ml/m\^2. We will now continue to escalate the dose of Optison at 0.300ml/m\^2 increments to a maximum single dose of 4ml or a total cumulative dose of 8.7 ml as recommended by the manufacturer.

Timeline

• Start date: 2002-06-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2005-09-16
• Last updated: 2011-09-20

Locations

1 site across 1 country: United States