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

September 9, 2005
June 1, 2011
January 2005
May 2007   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00162045 on ClinicalTrials.gov Archive Site
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 ]
A determiniation 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
Not Provided
Not Provided
 
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Kawasaki Disease
Drug: Technetium Tc99m Sestamibi
Rest and/or stress SPECT imaging study
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
79
June 2007
May 2007   (final data collection date for primary outcome measure)

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).
Both
4 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Taiwan
 
NCT00162045
DuP 843-201
No
Qi Zhu, MD Senior Medical Director, Lantheus Medical Imaging
Lantheus Medical Imaging
Not Provided
Study Director: Qi Zhu, MD Lantheus Medical Imaging
Lantheus Medical Imaging
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP