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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
79
Rest and/or stress SPECT imaging study
Jackson Memorial Hospital
Miami, Florida, United States
Local Institution
Honolulu, Hawaii, United States
University of Chicago Children's Hospital
Chicago, Illinois, United States
Determination of the absorbed radiation dose of Sestamibi in subjects will be evaluated at the end of the study through measurements of PK (blood and urine) up to 8 hours, dosimetry for 8 hours and image biodistribution for up to 8 hours
Time frame: Following administration of Technetium Tc99m Sestamibi
A determination of the safety of Sestamibi will be evaluated at the end of the study through adverse and serious adverse events reported and evaluating vital signs, ECGs, physical exams and laboratory tests for each subject
Time frame: Following administration of Technetium Tc99m Sestamibi
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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