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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

St. Jude Children's Research Hospital

ClinicalTrials.gov Identifier:

NCT00186953

First received: September 12, 2005

Last updated: September 19, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

September 19, 2011

Start Date ^ICMJE

June 2002

Primary Completion Date

August 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. ] [ Designated as safety issue: Yes ]
To learn the effects (good and bad) of using Optison during ultrasound. [ Time Frame: Unknown-study temporarily closed. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.
To learn the effects (good and bad) of using Optison during ultrasound.
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.

Change History

Complete list of historical versions of study NCT00186953 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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."

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Abdominal Neoplasms
Pelvic Neoplasms

Intervention ^ICMJE

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.

Study Arm (s)

Intervention: Drug: Optison

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2004

Primary Completion Date

August 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

2 Years to 20 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00186953

Other Study ID Numbers ^ICMJE

OPTUS

Has Data Monitoring Committee

Responsible Party

St. Jude Children's Research Hospital

Study Sponsor ^ICMJE

St. Jude Children's Research Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mary E. McCarville, M.D.

St. Jude Children's Research Hospital

Information Provided By

St. Jude Children's Research Hospital

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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