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

Sponsor

St. Jude Children's Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00186953

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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."

Condition or Disease	Intervention/Treatment	Phase
Abdominal Neoplasms Pelvic Neoplasms	Drug: Optison	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jun 1, 2002

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Aug 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Other: 1	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.

Arm

Intervention/Treatment

Other: 1

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.

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.