Technetium Tc-99m sestamibi

Overview

Technetium Tc-99m sestamibi (commonly sestamibi) is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands, hence the name sesta (6) MIBI.. Following intravenous injection of the drug, Technetium Tc-99m sestamibi is taken up by the myocardium, parathyroid, and/or breast tissue. The mechanism by which sestamibi localizes to these tissues has not been established. Single photon emission computed tomography (SPECT) is then performed to detect the gamma ray emmitted by the decay of Technetium-99m to Technetium-99. Currently available within a preparation kit for injection, Technetium Tc 99m Sestamibi is indicated for: 1) detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects); and 2) evaluating myocardial function and developing information for use in patient management decisions.

Indication

Technetium Tc 99m Sestamibi is indicated for: 1) detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects); and 2) evaluating myocardial function and developing information for use in patient management decisions.

Associated Conditions

Coronary Artery Disease (CAD)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparative Performance of Molecular Breast Imaging (MBI) to Magnetic Resonance Imaging (MRI) of the Breast in Identifying and Excluding Breast Carcinoma in Women at High Risk for Breast Cancer	2021/09/13	NCT05042687	Not Applicable	Recruiting	M.D. Anderson Cancer Center
99mTc Sestamibi Scans In Thyroglobulin Positive Scan Negative Differentiated Thyroid Cancer (DTC) Patients	2017/02/27	NCT03065218	Phase 4	Terminated	Medstar Health Research Institute
Stress and Rest Myocardial Tomoscintigraphies Using Mono- or Double-isotope Protocol With a Semiconductor Camera	2016/08/16	NCT02869126	Not Applicable	Completed	Central Hospital, Nancy, France
DCE-MRI and MBI in Assessing Tumor Response to Chemotherapy in Patients With Triple Negative Breast Cancer	2016/04/20	NCT02744053	Early Phase 1	Active, not recruiting	M.D. Anderson Cancer Center
Tc99m Sestamibi Molecular Breast Imaging	2014/12/24	NCT02324387	Not Applicable	Active, not recruiting	M.D. Anderson Cancer Center
Low Dose Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts	2013/08/19	NCT01925170	Not Applicable	Completed	Mayo Clinic
Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts	2008/02/21	NCT00620373	Not Applicable	Completed	Mayo Clinic
A Trial to Determine Radiation Exposure to Organs and Assess the Safety of CARDIOLITE® in Pediatric Subjects	2005/09/13	NCT00162045	Phase 1	Completed	Lantheus Medical Imaging
Post-PCI:Cardiac Imaging in Patients With Diabetes to Detect Coronary Artery Blockages Previously Opened by Angioplasty	2005/09/13	NCT00162357	Phase 4	Completed	Lantheus Medical Imaging
A Study of Stress Heart Imaging in Patients With Diabetes at Risk for Coronary Disease.	2005/09/13	NCT00162344	Phase 4	Completed	Lantheus Medical Imaging

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
TECHNETIUM TC 99M SESTAMIBI	Jubilant Draximage (USA) Inc.	45548-141	INTRAVENOUS	1 mg in 1 mL	8/13/2017
Kit for the Preparation of Technetium Tc99m Sestamibi	Sun Pharmaceutical Industries, Inc.	45567-0555	INTRAVENOUS	1 mg in 10 mL	3/31/2020
Kit for the Preparation of Technetium Tc99m Sestamibi	Cardinal Health 414, LLC	65857-500	PARENTERAL	1 mg in 5 mL	11/16/2017

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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