Clinical trial · Interventional
Determination of a Safe Dose of Optison in Pediatric Patients With Solid Tumors
Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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."
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Neoplasms | — | UNRESOLVED | — |
| Pelvic Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Optison | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- 1
- interventionNames
- Drug: Optison
Primary outcomes (3)
- measure
- To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.
- timeFrame
- Unknown-study temporarily closed.
- measure
- To learn the effects (good and bad) of using Optison during ultrasound.
- timeFrame
- Unknown-study temporarily closed.
- measure
- 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.
- timeFrame
- Unknown-study temporarily closed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDAnderson LN, Maguire JL, Lebovic G, Hanley AJ, Hamilton J, Adeli K, McCrindle BW, Borkhoff CM, Parkin PC, Birken CS; Applied Research Group for Kids! (TARGet Kids!) Collaboration. Duration of Fasting, Serum Lipids, and Metabolic Profile in Early Childhood. J Pediatr. 2017 Jan;180:47-52.e1. doi: 10.1016/j.jpeds.2016.09.005. Epub 2016 Oct 11. PMID 27742126