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

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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

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


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

Genetics Home Reference related topics: Kawasaki disease

Drug Information available for: Technetium Tc-99m Technetium Tc 99m sestamibi

Genetic and Rare Diseases Information Center resources: Kawasaki Disease

U.S. FDA Resources

Arms and Interventions

Intervention Details:

Drug: Technetium Tc99m Sestamibi
Rest and/or stress SPECT imaging study

Outcome Measures

Primary Outcome Measures :

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 :

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

Information from the National Library of Medicine

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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

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


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


Study Director:	Qi Zhu, MD	Lantheus Medical Imaging

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Qi Zhu, MD Senior Medical Director, Lantheus Medical Imaging
ClinicalTrials.gov Identifier:	NCT00162045 History of Changes
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:


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

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