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

Kawasaki Disease Clinical Trial

Official title:

A Phase I-II, Open-Label, Multicenter Trial to Determine the Dosimetry and Safety of Technetium Tc99m Sestamibi in Pediatric Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162045
• Other study ID #: DuP 843-201
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 9, 2005
• Last updated: June 1, 2011
• Start date: January 2005
• Est. completion date: June 2007

Study information

• Verified date: June 2011
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 16 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

Drug:
• Technetium Tc99m Sestamibi
Rest and/or stress SPECT imaging study

Locations

Country	Name	City	State
Canada	Local Institution	Vancouver	British Columbia
Taiwan	Local Institution	Changhua
Taiwan	Local Institution	Taichung
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago Children's Hospital	Chicago	Illinois
United States	Local Institution	Honolulu	Hawaii
United States	Jackson Memorial Hospital	Miami	Florida
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital and Regional Medical Center	Seattle	Washington
United States	Children's Hospital of Wisconsin	Wauwatosa	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Lantheus Medical Imaging

Countries where clinical trial is conducted

United States,  Canada,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes