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

This study has been completed.
Sponsor:
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00162045
First received: September 9, 2005
Last updated: June 1, 2011
Last verified: June 2011
  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: Technetium Tc99m Sestamibi
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 [ Time Frame: Following administration of Technetium Tc99m Sestamibi ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Enrollment: 79
Study Start Date: January 2005
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Technetium Tc99m Sestamibi
    Rest and/or stress SPECT imaging study
  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
Changhua, Taiwan
Local Institution
Taichung, Taiwan
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Qi Zhu, MD Lantheus Medical Imaging
  More Information

No publications provided

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
Study First Received: September 9, 2005
Last Updated: June 1, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014