Determination of a Safe Dose of Optison in Pediatric Patients With Solid Tumors
This study has been completed.
Sponsor:
St. Jude Children's Research Hospital
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00186953
First received: September 12, 2005
Last updated: September 19, 2011
Last verified: September 2011
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Purpose
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."
| Condition | Intervention | Phase |
|---|---|---|
|
Abdominal Neoplasms Pelvic Neoplasms |
Drug: Optison |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients |
Resource links provided by NLM:
Further study details as provided by St. Jude Children's Research Hospital:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 14 |
| Study Start Date: | June 2002 |
| Study Completion Date: | August 2004 |
| Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1 |
Drug: Optison
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. |
Eligibility| Ages Eligible for Study: | 2 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186953
Locations
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States, 38105 | |
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
| Principal Investigator: | Mary E. McCarville, M.D. | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00186953 History of Changes |
| Other Study ID Numbers: | OPTUS |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 19, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by St. Jude Children's Research Hospital:
|
Ultrasound Abdominal tumors Pelvic tumors |
Additional relevant MeSH terms:
|
Abdominal Neoplasms Neoplasms Pelvic Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 16, 2013