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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 Optisonâ„¢. St. Jude Children's Research Hospital researchers want to learn the best and safest dose of this ultrasound "dye."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optison | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To learn the best dose of Optisonâ„¢ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors. | Unknown-study temporarily closed. | |
| To learn the effects (good and bad) of using Optison during ultrasound. | Unknown-study temporarily closed. | |
| 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. | Unknown-study temporarily closed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary E. McCarville, M.D. | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27742126 | Derived | Anderson 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. |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| D010386 | Pelvic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C099458 | FS 069 |
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