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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00162045
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:
Lantheus Medical Imaging

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date June 2, 2011
Study Start Date  ICMJE January 2005
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2011)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
Official Title  ICMJE 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Kawasaki Disease
Intervention  ICMJE Drug: Technetium Tc99m Sestamibi
Rest and/or stress SPECT imaging study
Study Arms  ICMJE Not Provided
Publications * Azarbar S, Salardini A, Dahdah N, Lazewatsky J, Sparks R, Portman M, Crane PD, Lee ML, Zhu Q. A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of 99mTc-Sestamibi in Pediatric Subjects. J Nucl Med. 2015 May;56(5):728-36. doi: 10.2967/jnumed.114.146795. Epub 2015 Apr 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 1, 2011)
79
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
24
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date May 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00162045
Other Study ID Numbers  ICMJE DuP 843-201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qi Zhu, MD Senior Medical Director, Lantheus Medical Imaging
Study Sponsor  ICMJE Lantheus Medical Imaging
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Qi Zhu, MD Lantheus Medical Imaging
PRS Account Lantheus Medical Imaging
Verification Date June 2011

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