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

NCT00186953 | Completed Phase 1

• 1 other identifier: OPTUS
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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."

Conditions

Abdominal Neoplasms; Pelvic Neoplasms

Keywords

Ultrasound; Abdominal tumors; Pelvic tumors

Outcome Measures

Primary Outcomes (3)

• 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.

• To learn the effects (good and bad) of using Optison during ultrasound.

  Unknown-study temporarily closed.

• 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.

Study Arms (1)

1

OTHER

Drug: Optison

Interventions

Optison DRUG

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.

1

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

• Anderson LN, Maguire JL, Lebovic G, Hanley AJ, Hamilton J, Adeli K, McCrindle BW, Borkhoff CM, Parkin PC, Birken CS; Applied Research Group for Kids! (TARGet Kids!) Collaboration. Duration of Fasting, Serum Lipids, and Metabolic Profile in Early Childhood. J Pediatr. 2017 Jan;180:47-52.e1. doi: 10.1016/j.jpeds.2016.09.005. Epub 2016 Oct 11.

  PMID: 27742126 DERIVED

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Abdominal Neoplasms; Pelvic Neoplasms

Interventions

FS 069

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Mary E. McCarville, M.D.

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2002
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: September 20, 2011

Record last verified: 2011-09

Locations

US (1)