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

Phase 1

Completed

• Conditions: Abdominal Neoplasms; Pelvic Neoplasms
• Interventions: Drug: Optison

• Registration Number: NCT00186953
• Lead Sponsor: St. Jude Children's Research Hospital

Brief 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."

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2004-08
• Study Completion: 2004-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-19
• Last Update Posted: 2011-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Age: 2-20 years old
• Subject has a known or suspected solid soft tissue tumor in the abdomen or pelvis.
• Subject is scheduled for other imaging or is already scheduled for an ultrasound or has already had adequate imaging performed at an outside institution.
• Subject is able to lie still for the exam without sedation.

Exclusion Criteria

• Known or suspected hypersensitivity to albumin, blood or blood products.
• History of open heart surgery, cyanotic congenital heart disease or an axygen saturation of less than 96% as determined by pulse oximetry.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Optison	-

Primary Outcome Measures

Name	Time	Method
To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.	Unknown-study temporarily closed.
To learn the effects (good and bad) of using Optison during ultrasound.	Unknown-study temporarily closed.
To learn if using Optison™ during ultrasound can show the size and location of a tumor, how the tumor is responding to chemotherapy, and whether it has moved into surrounding tissue.	Unknown-study temporarily closed.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States