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

June 1, 2011 updated by: Lantheus Medical Imaging

A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Local Institution
  • Taiwan
      • Changhua, Taiwan
        • Local Institution
      • Taichung, Taiwan
        • Local Institution
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
    • Hawaii
      • Honolulu, Hawaii, United States, 96810
        • Local Institution
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Washington
      • Seattle, Washington, United States, 98105
        • Children's Hospital and Regional Medical Center
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 29425
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Following administration of Technetium Tc99m Sestamibi

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Following administration of Technetium Tc99m Sestamibi

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lantheus Medical Imaging

Investigators

  • Study Director: Qi Zhu, MD, Lantheus Medical Imaging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 13, 2005

Study Record Updates

Last Update Posted (Estimate)

June 2, 2011

Last Update Submitted That Met QC Criteria

June 1, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DuP 843-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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