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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

December 9, 2008

Start Date ^†

January 2005

Current 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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00162045 on ClinicalTrials.gov Archive Site

Current 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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official Title ^†

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

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.

Detailed Description

Study Phase

Phase I, Phase II

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^†

Kawasaki Disease

Intervention ^†

Drug: Sestamibi

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility 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).

Gender

Both

Ages

4 Years to 16 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Canada, Taiwan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00162045

Responsible Party

Qi Zhu, MD Senior Medical Director, Lantheus Medical Imaging

Secondary IDs ^††

Study Sponsor ^†

Lantheus Medical Imaging

Collaborators ^††

Investigators ^†

Study Director:

Qi Zhu, MD

Lantheus Medical Imaging

Information Provided By

Lantheus Medical Imaging

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.