Skip to main content
OpenTrials
Completed

NCT Number: NCT00186953

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

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."

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Abdominal Neoplasms Neoplasms Neoplasms by Site Pelvic Neoplasms

Age range

2 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optison

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.

Primary outcomes

  1. To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.

    Time frame: Unknown-study temporarily closed.

  2. To learn the effects (good and bad) of using Optison during ultrasound.

    Time frame: Unknown-study temporarily closed.

  3. 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.

    Time frame: Unknown-study temporarily closed.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Sep 16, 2005
Registry last updated
Sep 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.