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

Study Overview
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Brief Summary
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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.

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

Conditions
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Abdominal Neoplasms, Pelvic Neoplasms

Intervention / Treatment
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* Drug: Optison


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br> | Drug: Optison<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Abdominal tumors, Pelvic tumors