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

Primary Purpose

Kawasaki Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Technetium Tc99m Sestamibi
Sponsored by
Lantheus Medical Imaging
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kawasaki Disease

Eligibility Criteria

4 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Jackson Memorial Hospital
  • Local Institution
  • University of Chicago Children's Hospital
  • Children's Hospital of Philadelphia
  • Medical University of South Carolina
  • Children's Hospital and Regional Medical Center
  • Children's Hospital of Wisconsin
  • Local Institution
  • Local Institution
  • Local Institution

Outcomes

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

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

Full Information

First Posted
September 9, 2005
Last Updated
June 1, 2011
Sponsor
Lantheus Medical Imaging
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1. Study Identification

Unique Protocol Identification Number
NCT00162045
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lantheus Medical Imaging

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kawasaki Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Technetium Tc99m Sestamibi
Intervention Description
Rest and/or stress SPECT imaging study
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi Zhu, MD
Organizational Affiliation
Lantheus Medical Imaging
Official's Role
Study Director
Facility Information:
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Local Institution
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96810
Country
United States
Facility Name
University of Chicago Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Children's Hospital and Regional Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
Local Institution
City
Changhua
Country
Taiwan
Facility Name
Local Institution
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25858045
Citation
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.
Results Reference
derived

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

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