A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
NCT00162045 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2011-06-02
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.
Conditions
- Kawasaki Disease
Interventions
- DRUG
-
Technetium Tc99m Sestamibi
Rest and/or stress SPECT imaging study
Sponsors & Collaborators
-
Lantheus Medical Imaging
lead INDUSTRY
Principal Investigators
-
Qi Zhu, MD · Lantheus Medical Imaging
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 4 Years
- Max Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-01-31
- Primary Completion
- 2007-05-31
- Completion
- 2007-06-30
Countries
- United States
- Canada
- Taiwan
Study Locations
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