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

Lantheus Medical Imaging7 sites in 2 countries79 target enrollmentJanuary 2005

ConditionsKawasaki Disease

DrugsTechnetium Tc99m Sestamibi

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Kawasaki Disease
Sponsor: Lantheus Medical Imaging
Enrollment: 79
Locations: 7
Primary Endpoint: 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
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

June 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Lantheus Medical Imaging

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).

Outcomes

Primary Outcomes

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 Outcomes

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)