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A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00162045
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:
Lantheus Medical Imaging

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kawasaki Disease Drug: Technetium Tc99m Sestamibi Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects
Study Start Date : January 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • Drug: Technetium Tc99m Sestamibi
    Rest and/or stress SPECT imaging study

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162045


Locations
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United States, Florida
Jackson Memorial Hospital
Miami, Florida, United States, 33136
United States, Hawaii
Local Institution
Honolulu, Hawaii, United States, 96810
United States, Illinois
University of Chicago Children's Hospital
Chicago, Illinois, United States, 60637
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
United States, Wisconsin
Children's Hospital of Wisconsin
Wauwatosa, Wisconsin, United States, 29425
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V6H 3V4
Taiwan
Local Institution
Changhua, Taiwan
Local Institution
Taichung, Taiwan
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
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Study Director: Qi Zhu, MD Lantheus Medical Imaging
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Qi Zhu, MD Senior Medical Director, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162045    
Other Study ID Numbers: DuP 843-201
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
 Skin Diseases, Vascular
Skin Diseases
Technetium Tc 99m Sestamibi
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action