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

Abdominal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186953
• Other study ID #: OPTUS
• Status: Completed
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: September 19, 2011
• Start date: June 2002
• Est. completion date: August 2004

Study information

• Verified date: September 2011
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 20 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Abdominal Neoplasms
• Neoplasms
• Pelvic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To learn the best dose of Optison™ ultrasound contrast agent that can be safely given to children with abdominal or pelvic tumors.		Unknown-study temporarily closed.	Yes
Primary	To learn the effects (good and bad) of using Optison during ultrasound.		Unknown-study temporarily closed.	Yes
Primary	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.		Unknown-study temporarily closed.	Yes

External Links

•   St. Jude Children's Research Hospital