A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects

Completed · Phase 1/Phase 2

Conditions studied: Kawasaki Disease

In brief

The purpose of this Phase I-II multicenter clinical trial is to establish dosimetry and safety profiles for CARDIOLITE® (Technetium Tc99m Sestamibi) in pediatric subjects.

Key facts

Study ID

NCT00162045

Run by

Lantheus Medical Imaging

People needed

79

Starts

2005-01-01

Expected to finish

2007-06-01

Last updated by the study team

2011-06-02

Who can join

Age: 4 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have been scheduled to undergo a clinically indicated rest or stress CARDIOLITE® MPI scan.
• Be able to comply with imaging requirements permitting completion of rest or stress CARDIOLITE® whole-body scans and SPECT imaging procedures without the use of sedation.

You may not qualify if…

• Have a terminal illness where expected survival is ≤6 months
• Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).

Where it is running

• Jackson Memorial Hospital — Miami, Florida, United States
• Local Institution — Honolulu, Hawaii, United States
• University of Chicago Children's Hospital — Chicago, Illinois, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Children's Hospital and Regional Medical Center — Seattle, Washington, United States
• Children's Hospital of Wisconsin — Wauwatosa, Wisconsin, United States
• Local Institution — Vancouver, British Columbia, Canada
• Local Institution — Changhua, Taiwan
• Local Institution — Taichung, Taiwan

Full record on ClinicalTrials.gov

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