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Determination of a Safe Dose of Optison in Pediatric Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00186953
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : September 20, 2011
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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."

Condition or disease Intervention/treatment Phase
Abdominal Neoplasms Pelvic Neoplasms Drug: Optison Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients
Study Start Date : June 2002
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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. ]
  2. To learn the effects (good and bad) of using Optison during ultrasound. [ Time Frame: Unknown-study temporarily closed. ]
  3. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00186953

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United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
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Principal Investigator: Mary E. McCarville, M.D. St. Jude Children's Research Hospital

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: St. Jude Children's Research Hospital Identifier: NCT00186953     History of Changes
Other Study ID Numbers: OPTUS
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: September 2011
Keywords provided by St. Jude Children's Research Hospital:
Abdominal tumors
Pelvic tumors
Additional relevant MeSH terms:
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Abdominal Neoplasms
Pelvic Neoplasms
Neoplasms by Site