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

NCT00186953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2011-09-20

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Mary E. McCarville, M.D. · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Primary Completion
2004-08-31
Completion
2004-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00186953 on ClinicalTrials.gov