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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2004-08-31

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."

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Detailed Description

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Conditions

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Abdominal Neoplasms Pelvic Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

Optison

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No