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Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients


Phase 1
2 Years
20 Years
Not Enrolling
Both
Abdominal Neoplasms, Pelvic Neoplasms

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Trial Information

Determination of Optimal Dose and Safety Profile of Optison Ultrasound Contrast Agent in Pediatric Solid Tumor Patients


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.

Outcome Time Frame:

Unknown-study temporarily closed.

Safety Issue:

Yes

Principal Investigator

Mary E. McCarville, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Food and Drug Administration

Study ID:

OPTUS

NCT ID:

NCT00186953

Start Date:

June 2002

Completion Date:

August 2004

Related Keywords:

  • Abdominal Neoplasms
  • Pelvic Neoplasms
  • Ultrasound
  • Abdominal tumors
  • Pelvic tumors
  • Abdominal Neoplasms
  • Neoplasms
  • Pelvic Neoplasms

Name

Location
St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794