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

Information source: St. Jude Children's Research Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Abdominal Neoplasms; Pelvic Neoplasms

Intervention: Optison (Drug)

Phase: Phase 1

Status: Suspended

Sponsored by: St. Jude Children's Research Hospital

Official(s) and/or principal investigator(s):
Mary E. McCarville, M.D., Principal Investigator, Affiliation: St. Jude Children's Research Hospital

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."

Clinical Details

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

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

Primary outcome:

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.

Eligibility

Minimum age: 2 Years. Maximum age: 20 Years. Gender(s): Both.

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.

Locations and Contacts

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

St. Jude Children's Research Hospital

Starting date: June 2002
Ending date: December 2010
Last updated: May 27, 2008

Page last updated: June 20, 2008

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