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

This study has been completed.

First Received: September 9, 2005 Last Updated: December 9, 2008 History of Changes

Sponsored by:	Lantheus Medical Imaging
Information provided by:	Lantheus Medical Imaging
ClinicalTrials.gov Identifier:	NCT00162045

Purpose

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	Intervention	Phase
Kawasaki Disease	Drug: Sestamibi	Phase I Phase II

MedlinePlus related topics: Kawasaki Disease Radiation Therapy

Drug Information available for: Technetium Tc 99m sestamibi

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects

Further study details as provided by Lantheus Medical Imaging:

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

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

Estimated Enrollment:	24
Study Start Date:	January 2005

Eligibility

Ages Eligible for Study:	4 Years to 16 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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
Taichung, Taiwan
Local Institution
Changhua, Taiwan

Sponsors and Collaborators

Lantheus Medical Imaging

Investigators

Study Director:

Qi Zhu, MD

Lantheus Medical Imaging

More Information

No publications provided

Responsible Party:	Lantheus Medical Imaging ( Qi Zhu, MD Senior Medical Director )
Study ID Numbers:	DuP 843-201
Study First Received:	September 9, 2005
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00162045 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Mucocutaneous Lymph Node Syndrome
Lymphatic Diseases
Vasculitis

Skin Diseases
Vascular Diseases
Kawasaki Syndrome

Additional relevant MeSH terms:

Mucocutaneous Lymph Node Syndrome
Lymphatic Diseases
Skin Diseases, Vascular
Vasculitis

Skin Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 06, 2009