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Technetium Tc99m Sestamibi

Phase 1

Kawasaki Disease | Small molecule | Other |Lantheus Holdings, Inc.|Last Updated: Jun 2, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00162045A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric SubjectsPHASE1 COMPLETED 79 — — Jan 1, 2005Jun 1, 2007Jun 2, 201110 United States, Canada +1
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Study Endpoints
Primary Endpoints
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 Endpoints
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
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC
Interventions
NameTypeDescription
Technetium Tc99m SestamibiDRUGRest and/or stress SPECT imaging study
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Eligibility Criteria
Age Range4 Years — 16 Years
SexALL
Healthy VolunteersNo
Study Sites10

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 Cr...

Countries:United StatesCanadaTaiwan
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