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

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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.
    


Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

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

 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

Condition

Kawasaki Disease

Intervention

Technetium Tc99m Sestamibi


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

Drug

Estimated Enrollment

79

Start Date

January 2005

Completion Date

June 2007

Primary Completion Date

May 2007

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

All

Ages

4 Years - 16 Years

Accepts Healthy Volunteers

No

Contacts

Qi Zhu, MD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT00162045

Organization ID

DuP 843-201



Study Sponsor

Lantheus Medical Imaging


Study Sponsor

Qi Zhu, MD, Study Director, Lantheus Medical Imaging


Verification Date

June 2011