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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study is ongoing, but not recruiting participants.

Study NCT00186953. Last updated on November 25, 2008. Information provided by St. Jude Children's Research Hospital

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

Condition ^†

Abdominal Neoplasms
Pelvic Neoplasms

Intervention ^†

Drug: Optison

MEDLINE PMIDs

Links

St. Jude Children's Research Hospital This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

132

Start Date ^†

June 2002

Completion Date

December 2010

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00186953

Organization ID

OPTUS

Secondary IDs ^††

Study Sponsor ^†

St. Jude Children's Research Hospital

Collaborators ^††

Investigators ^†

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

First Received Date ^†

September 12, 2005

Last Updated Date

November 25, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.