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

Sponsor:	St. Jude Children's Research Hospital
Information provided by:	St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:	NCT00186953

Purpose

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."

Condition	Intervention	Phase
Abdominal Neoplasms Pelvic Neoplasms	Drug: Optison	Phase I

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ultrasound

U.S. FDA Resources

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	132
Study Start Date:	June 2002
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1	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.

Eligibility

Ages Eligible for Study:	2 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00186953

Locations

United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105

Sponsors and Collaborators

St. Jude Children's Research Hospital

Investigators

Principal Investigator:

Mary E. McCarville, M.D.

St. Jude Children's Research Hospital

More Information

Additional Information:

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

No publications provided

Responsible Party:	St. Jude Children's Research Hospital ( Mary E. McCarville, M.D. )
Study ID Numbers:	OPTUS
Study First Received:	September 12, 2005
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00186953 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by St. Jude Children's Research Hospital:

Ultrasound
Abdominal tumors
Pelvic tumors

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Abdominal Neoplasms
Pelvic Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009