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

Phase 1

Completed

• Conditions: Kawasaki Disease

• Registration Number: NCT00162045
• Lead Sponsor: Lantheus Medical Imaging

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Primary Completion: 2007-05
• Study Completion: 2007-06
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-01
• Last Update Posted: 2011-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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.

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Exclusion Criteria

• Have a terminal illness where expected survival is ≤6 months
• Have known clinically significant laboratory abnormalities (creatine, liver enzymes, platelet count).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	Following administration of Technetium Tc99m Sestamibi

Secondary Outcome Measures

Name	Time	Method
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	Following administration of Technetium Tc99m Sestamibi

Trial Locations

Locations (7)

Local Institution; 🇨🇳 Taichung, Taiwan

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Children's Hospital and Regional Medical Center; 🇺🇸 Seattle, Washington, United States

Children's Hospital of Wisconsin; 🇺🇸 Wauwatosa, Wisconsin, United States

University of Chicago Children's Hospital; 🇺🇸 Chicago, Illinois, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States