Status:
COMPLETED
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
Lead Sponsor:
Lantheus Medical Imaging
Conditions:
Kawasaki Disease
Eligibility:
All Genders
4-16 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Have a terminal illness where expected survival is ≤6 months
- Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00162045
Start Date
January 1 2005
End Date
June 1 2007
Last Update
June 2 2011
Active Locations (10)
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1
Jackson Memorial Hospital
Miami, Florida, United States, 33136
2
Local Institution
Honolulu, Hawaii, United States, 96810
3
University of Chicago Children's Hospital
Chicago, Illinois, United States, 60637
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104