A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
NCT ID: NCT00162045
Last Updated: 2011-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
79 participants
INTERVENTIONAL
2005-01-31
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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Technetium Tc99m Sestamibi
Rest and/or stress SPECT imaging study
Eligibility Criteria
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Inclusion Criteria
* 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 known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).
4 Years
16 Years
ALL
No
Sponsors
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Lantheus Medical Imaging
INDUSTRY
Responsible Party
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Lantheus Medical Imaging
Principal Investigators
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Qi Zhu, MD
Role: STUDY_DIRECTOR
Lantheus Medical Imaging
Locations
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Jackson Memorial Hospital
Miami, Florida, United States
Local Institution
Honolulu, Hawaii, United States
University of Chicago Children's Hospital
Chicago, Illinois, United States
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
Countries
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References
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Azarbar S, Salardini A, Dahdah N, Lazewatsky J, Sparks R, Portman M, Crane PD, Lee ML, Zhu Q. A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of 99mTc-Sestamibi in Pediatric Subjects. J Nucl Med. 2015 May;56(5):728-36. doi: 10.2967/jnumed.114.146795. Epub 2015 Apr 9.
Other Identifiers
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DuP 843-201
Identifier Type: -
Identifier Source: org_study_id
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