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

NCT ID: NCT00162045

Last Updated: 2011-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-06-30

Brief Summary

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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

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Conditions

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Kawasaki Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Technetium Tc99m Sestamibi

Rest and/or stress SPECT imaging study

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

4 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lantheus Medical Imaging

INDUSTRY

Sponsor Role lead

Responsible Party

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Lantheus Medical Imaging

Principal Investigators

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Qi Zhu, MD

Role: STUDY_DIRECTOR

Lantheus Medical Imaging

Locations

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Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Local Institution

Honolulu, Hawaii, United States

Site Status

University of Chicago Children's Hospital

Chicago, Illinois, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Children's Hospital and Regional Medical Center

Seattle, Washington, United States

Site Status

Children's Hospital of Wisconsin

Wauwatosa, Wisconsin, United States

Site Status

Local Institution

Vancouver, British Columbia, Canada

Site Status

Local Institution

Changhua, , Taiwan

Site Status

Local Institution

Taichung, , Taiwan

Site Status

Countries

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United States Canada Taiwan

References

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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.

Reference Type DERIVED
PMID: 25858045 (View on PubMed)

Other Identifiers

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DuP 843-201

Identifier Type: -

Identifier Source: org_study_id

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