Kawasaki Disease
Conditions
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.
Interventions
Rest and/or stress SPECT imaging study
Sponsors
Lantheus Medical Imaging
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Have a terminal illness where expected survival is ≤6 months * Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | Following administration of Technetium Tc99m Sestamibi |
Secondary
| Measure | Time frame |
|---|---|
| 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 | Following administration of Technetium Tc99m Sestamibi |
Countries
Canada, Taiwan, United States
Outcome results
None listed