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

Primary Purpose

Abdominal Neoplasms, Pelvic Neoplasms

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Optison

About this trial

This is an interventional diagnostic trial for Abdominal Neoplasms focused on measuring Ultrasound, Abdominal tumors, Pelvic tumors

Eligibility Criteria

2 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

St. Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00186953

First Posted

September 12, 2005

Last Updated

September 19, 2011

Sponsor

St. Jude Children's Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00186953

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

June 2002 (undefined)

Primary Completion Date

August 2004 (Actual)

Study Completion Date

August 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Jude Children's Research Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Neoplasms, Pelvic Neoplasms

Keywords

Ultrasound, Abdominal tumors, Pelvic tumors

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Optison

Intervention Description

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 Measure Information:

Title

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.

Title

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

Time Frame

Unknown-study temporarily closed.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary E. McCarville, M.D.

Organizational Affiliation

St. Jude Children's Research Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Jude Children's Research Hospital

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27742126

Citation

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.

Results Reference

derived

Links:

URL

http://www.stjude.org

Description

St. Jude Children's Research Hospital

Learn more about this trial

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

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