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| Descriptive Information Fields | |||||
| Brief Title † | Determination of a Safe Dose of Optison in Pediatric Patients With Solid Tumors | ||||
| Official Title † | Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients | ||||
| 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." |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Diagnostic, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study | ||||
| Primary Outcome Measure † | 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. ] [ Designated as safety issue: Yes ] To learn the effects (good and bad) of using Optison during ultrasound. [ Time Frame: Unknown-study temporarily closed. ] [ Designated as safety issue: Yes ] 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. ] [ Designated as safety issue: Yes ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Abdominal Neoplasms Pelvic Neoplasms |
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| Intervention † | Drug: Optison | ||||
| MEDLINE PMIDs | |||||
| Links | St. Jude Children's Research Hospital ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 132 | ||||
| Start Date † | June 2002 | ||||
| Completion Date | December 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 2 Years to 20 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00186953 | ||||
| Organization ID | OPTUS | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | St. Jude Children's Research Hospital | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | St. Jude Children's Research Hospital | ||||
| Verification Date | November 2008 | ||||
| First Received Date † | September 12, 2005 | ||||
| Last Updated Date | November 25, 2008 | ||||