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

ClinicalTrials.gov ID NCT00186953
Sponsor St. Jude Children's Research Hospital
Information provided by St. Jude Children's Research Hospital (Responsible Party)
Last Update Posted 2011-09-20
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Study Overview

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."

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Official Title
Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients
Conditions
Abdominal Neoplasms
Pelvic Neoplasms
Intervention / Treatment
  • Drug: Optison
  • Drug: Optison
Other Study ID Numbers
  • OPTUS
Study Start
2002-06
Primary Completion (Actual)
2004-08
Study Completion (Actual)
2004-08
Enrollment (Actual)
14
Study Type
Interventional
Phase
Phase 1

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
United States
Tennessee Locations
Memphis, Tennessee, United States, 38105

St. Jude Children's Research Hospital
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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
Description

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.
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Ages Eligible for Study
2 Years to 20 Years (ChildAdult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Other: 1 Intervention/Treatment 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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
St. Jude Children's Research Hospital
Investigators
  • Principal Investigator:Mary E. McCarville, M.D.,St. Jude Children's Research Hospital

Publications

From PubMed

These publications come from PubMed, a public database of scientific and medical articles. This list is automatically created by ClinicalTrials.gov Identifier (NCT Number), and these articles may or may not be about the study.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2005-09-12
First Submitted that Met QC Criteria
2005-09-12
First Posted (Estimated)
2005-09-16
Study Record Updates
Last Update Submitted that met QC Criteria
2011-09-19
Last Update Posted (Estimated)
2011-09-20
Last Verified
2011-09

More Information

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Keywords Provided by St. Jude Children's Research Hospital
Additional Relevant MeSH Terms