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
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
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
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
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
To learn the best dose of Optisonâ¢ 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 Optisonâ¢ 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.
Minimum age: 2 Years.
Maximum age: 20 Years.
- 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.
- 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
St. Jude Children's Research Hospital
Starting date: June 2002
Ending date: December 2010
Last updated: May 27, 2008