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Technetium Tc99m Sestamibi

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

Technetium Tc99m Sestamibi · 1 trial · 1 indication

Phase 1 1
NCT00162045A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric SubjectsKawasaki Disease
COMPLETED79 Analytics
PHASE1COMPLETED
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects
Kawasaki DiseaseUnlock trial analytics

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 to 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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Frequently asked questions about Technetium Tc99m Sestamibi

What is Technetium Tc99m Sestamibi used for in Kawasaki Disease?

Technetium Tc99m Sestamibi is a small molecule radiopharmaceutical being studied for use in Kawasaki Disease. It is an investigational diagnostic agent intended to assess cardiac involvement in pediatric patients with this condition. The drug is currently in Phase 1 clinical development, meaning it is still being evaluated for safety and dosing.

What does Technetium Tc99m Sestamibi target?

Technetium Tc99m Sestamibi is a radiotracer that accumulates in myocardial tissue, allowing imaging of blood flow to the heart. In Kawasaki Disease, it is used to evaluate potential coronary artery abnormalities. The drug's mechanism relies on its uptake by cardiac cells, which can be visualized using nuclear imaging techniques.

Who makes Technetium Tc99m Sestamibi?

Technetium Tc99m Sestamibi is developed by Lantheus Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LNTH. The company is conducting clinical research to evaluate the drug's safety and efficacy in pediatric patients with Kawasaki Disease.

What phase is Technetium Tc99m Sestamibi in?

Technetium Tc99m Sestamibi is in Phase 1 clinical development for Kawasaki Disease. It is an investigational drug, meaning it has not been approved by regulatory authorities for this indication. The Phase 1 trial is complete, and the drug remains under investigation for potential future use.

What clinical trials is Technetium Tc99m Sestamibi in?

Technetium Tc99m Sestamibi has one completed clinical trial, NCT00162045, titled 'A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects.' This Phase 1 study enrolled 79 participants with Kawasaki Disease across the United States, Canada, and Taiwan.

Is Technetium Tc99m Sestamibi the same as CARDIOLITE?

Yes, Technetium Tc99m Sestamibi is the same as CARDIOLITE, as indicated by the clinical trial title referencing CARDIOLITE®. The drug is also known by this brand name, which may be used interchangeably in research and clinical contexts.