A Phase 1/2 interventional study of Technetium Tc99m Sestamibi in Kawasaki Disease, sponsored by Lantheus Medical Imaging. Completed at 10 sites in 3 countries. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2011-06-02.
Sponsored by Lantheus Medical Imaging · Phase 1/2, Interventional, and Diagnostic
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.
64 studies on the registry are indexed under Mucocutaneous Lymph Node Syndrome; 18 are open to participants now.
This study's enrollment of 79 is above the median of 45 across 35 interventional studies indexed under Mucocutaneous Lymph Node Syndrome.
Browse Mucocutaneous Lymph Node Syndrome studies →Lantheus Medical Imaging is the lead sponsor of 30 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rest and/or stress SPECT imaging study
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
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mucocutaneous Lymph Node Syndrome→
Lantheus Medical Imaging