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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

November 25, 2008

Start Date ^ICMJE

June 2002

Estimated Primary Completion Date

December 2010 (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

Original Secondary Outcome Measures ^ICMJE

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study

Condition ^ICMJE

Abdominal Neoplasms
Pelvic Neoplasms

Intervention ^ICMJE

Drug: Optison

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

132

Estimated Completion Date

December 2010

Estimated Primary Completion Date

December 2010 (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 ID ^ICMJE

NCT00186953

Responsible Party

Mary E. McCarville, M.D., St. Jude Children's Research Hospital

Study ID Numbers ^ICMJE

OPTUS

Study Sponsor ^ICMJE

St. Jude Children's Research Hospital

Collaborators ^ICMJE

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

November 2008

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