Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.
Study Overview
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."
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Intervention: Optison (Drug)
Outcomes
Primary Outcomes
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.
To learn the effects (good and bad) of using Optison during ultrasound.
Time Frame: Unknown-study temporarily closed.
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.
Secondary Outcomes
No secondary outcomes reported