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Last Updated: April 11, 2025

CLINICAL TRIALS PROFILE FOR TECHNETIUM TC-99M PYROPHOSPHATE KIT


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All Clinical Trials for TECHNETIUM TC-99M PYROPHOSPHATE KIT

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT03702829 ↗ 24 Month Open Label Study of the Tolerability and Efficacy of Inotersen in TTR Amyloid Cardiomyopathy Patients Active, not recruiting Brigham and Women's Hospital Phase 2 2019-02-28 Transthyretin is a protein produced in the liver that transports thyroid hormone and vitamin A. A single substitution of an amino acid in the structure of TTR can result in a relatively unstable protein, the breakdown products of which (predominantly monomers) aggregate abnormally and produce proteinaceous deposits in nerves and the heart. These deposits are known as amyloid and produce progressive nerve and heart damage. Amyloidosis due to a mutant TTR is usually an autosomal dominant and hence is a familial condition. Wild-type TTR is also capable of producing amyloid deposits which predominantly involves the heart (rather than the nervous system) resulting in a progressive decrease in cardiac function with increasing signs of heart failure. This study aims to determine whether subcutaneous injection of an antisense oligonucleotide drug, known as inotersen, that has been specifically designed to reduce production of the protein transthyretin by the liver, can slow or stop the progression of TTR amyloid cardiomyopathy as compared to historical controls, using advanced echocardiography and cardiac MRI. The study also aims to determine the tolerability and safety of this drug when administered over a 24-month period to patients with TTR amyloid cardiomyopathy.
NCT03040427 ↗ The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis Terminated Avid Radiopharmaceuticals Phase 4 2017-01-01 The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.
NCT03040427 ↗ The Role of F-18 Florbetapir in the Early Detection of Cardiac Amyloidosis Terminated The Cleveland Clinic Phase 4 2017-01-01 The investigators postulate that F-18 florbetapir will show improved detection of cardiac amyloidosis over conventional non-invasive imaging techniques, particularly in early disease.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for TECHNETIUM TC-99M PYROPHOSPHATE KIT

Condition Name

110-0.100.10.20.30.40.50.60.70.80.911.1AmyloidosisCardiac Amyloidosis[disabled in preview]
Condition Name for TECHNETIUM TC-99M PYROPHOSPHATE KIT
Intervention Trials
Amyloidosis 1
Cardiac Amyloidosis 1
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Condition MeSH

210-0.200.20.40.60.811.21.41.61.822.2AmyloidosisCardiomyopathies[disabled in preview]
Condition MeSH for TECHNETIUM TC-99M PYROPHOSPHATE KIT
Intervention Trials
Amyloidosis 2
Cardiomyopathies 1
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Clinical Trial Locations for TECHNETIUM TC-99M PYROPHOSPHATE KIT

Trials by Country

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Trials by Country for TECHNETIUM TC-99M PYROPHOSPHATE KIT
Location Trials
United States 2
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Trials by US State

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Trials by US State for TECHNETIUM TC-99M PYROPHOSPHATE KIT
Location Trials
Massachusetts 1
Ohio 1
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Clinical Trial Progress for TECHNETIUM TC-99M PYROPHOSPHATE KIT

Clinical Trial Phase

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4Phase 2[disabled in preview]
Clinical Trial Phase for TECHNETIUM TC-99M PYROPHOSPHATE KIT
Clinical Trial Phase Trials
Phase 4 1
Phase 2 1
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Clinical Trial Status

50.0%50.0%0-0.100.10.20.30.40.50.60.70.80.911.1Active, not recruitingTerminated[disabled in preview]
Clinical Trial Status for TECHNETIUM TC-99M PYROPHOSPHATE KIT
Clinical Trial Phase Trials
Active, not recruiting 1
Terminated 1
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Clinical Trial Sponsors for TECHNETIUM TC-99M PYROPHOSPHATE KIT

Sponsor Name

trials000001111111Brigham and Women's HospitalAvid RadiopharmaceuticalsThe Cleveland Clinic[disabled in preview]
Sponsor Name for TECHNETIUM TC-99M PYROPHOSPHATE KIT
Sponsor Trials
Brigham and Women's Hospital 1
Avid Radiopharmaceuticals 1
The Cleveland Clinic 1
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Sponsor Type

66.7%33.3%0-0.200.20.40.60.811.21.41.61.822.2OtherIndustry[disabled in preview]
Sponsor Type for TECHNETIUM TC-99M PYROPHOSPHATE KIT
Sponsor Trials
Other 2
Industry 1
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Technetium Tc-99m Pyrophosphate Kit: Clinical Trials, Market Analysis, and Projections

Introduction

Technetium Tc-99m Pyrophosphate Kit is a diagnostic radiopharmaceutical widely used in nuclear medicine for various imaging applications, including skeletal and cardiac imaging. Here, we will delve into the current clinical trials, market analysis, and future projections for this crucial medical tool.

Clinical Trials and Diagnostic Accuracy

Cardiac Amyloidosis Detection

Recent clinical trials have highlighted the efficacy of Technetium Tc-99m Pyrophosphate (Tc 99m PYP) in detecting transthyretin cardiac amyloidosis (ATTR cardiac amyloidosis). A multicenter study demonstrated that Tc 99m PYP cardiac imaging can detect ATTR cardiac amyloidosis with high sensitivity and specificity, differentiating it from other types of amyloidosis[4].

Myocardial Infarction Imaging

Tc 99m Pyrophosphate Injection is also used as an adjunct in the diagnosis of acute myocardial infarction. It has been shown to visualize the infarcted area from 24 hours to nine days after the onset of symptoms, with maximum localization at 48 to 72 hours. However, false negative images can occur if imaging is done too early or too late in the infarct's evolutionary phase[1].

Other Clinical Applications

The kit is also utilized for bone imaging to demonstrate areas of altered osteogenesis and for other diagnostic purposes such as detecting gastrointestinal bleeding and performing gated blood pool imaging[5].

Market Analysis

Current Market Size and Growth

The Technetium-99m market, which includes the Tc-99m Pyrophosphate Kit, was valued at approximately USD 4.95 billion in 2023. It is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.05% from 2024 to 2030, reaching nearly USD 6.54 billion by 2030[2].

Market Segmentation

The market is segmented by application, with cardiovascular imaging holding the largest share due to its critical role in myocardial perfusion imaging. Other significant segments include bone scans, respiratory imaging, and tumor imaging. North America, particularly the United States and Canada, dominates the global market due to advanced healthcare infrastructure and high prevalence of chronic diseases[2].

Regional Demand

Emerging markets such as China are also seeing increased demand for Tc-99m-based Single Photon Emission Computed Tomography (SPECT) imaging, driven by the development of healthcare infrastructure and the need for reliable and cost-effective diagnostic tools[2].

Market Drivers and Opportunities

Advancements in Radiopharmaceuticals

The development of new Tc-99m-based radiopharmaceuticals with improved specificity and sensitivity is a key driver of market growth. These advancements enable more accurate diagnosis and targeted imaging of various diseases, including cancer, cardiovascular disease, and neurological disorders[2].

Increasing Diagnostic Procedures

The growing number of diagnostic procedures using Tc-99m, particularly in cardiovascular imaging, fuels the market growth. Tc-99m is used in more than 80% of all nuclear medicine procedures in the United States, highlighting its widespread adoption[2].

Healthcare Infrastructure Expansion

The expansion of healthcare infrastructure, rise in healthcare expenditure, and global health initiatives emphasizing innovative medical technologies are bolstering the demand for Tc-99m-based products. Governments are implementing health programs to increase diagnostic imaging and treatment options, further driving the market[3].

Market Challenges

Supply Chain Complexity

The technetium-99m market faces challenges due to its complex and delicate supply chain. The production and distribution of Tc-99m rely on a just-in-time model, which requires continuous production and careful coordination between government and commercial entities. Disruptions in this supply chain can significantly impact the availability of Tc-99m[2].

Regulatory and Financial Issues

Older nuclear reactors that produce Tc-99m often struggle financially, and the increasing power of some manufacturers of processors and generators makes the supply chain more vulnerable to disruptions. Additionally, government-controlled enriched uranium and nuclear medicine rules influence the supply and pricing of Tc-99m[2].

Future Projections

Continued Growth in Demand

The demand for Tc-99m-based radiopharmaceuticals is expected to continue growing, driven by the need for advanced nuclear imaging infrastructure for illness detection and treatment. The evolving SPECT detector technology and its wider range of applications in preclinical research and diagnostic accuracy will further fuel this growth[3].

Emerging Markets

Emerging markets, particularly in regions like China, present significant opportunities for the technetium-99m market. The sustained imaging power of SPECT using Tc-99m radiopharmaceuticals makes it a reliable and cost-effective diagnostic tool in these regions[2].

Innovations and Research

Ongoing research and development efforts focused on creating new Tc-99m-based radiopharmaceuticals with improved specificity and sensitivity will continue to drive market growth. These innovations will enable more accurate and early disease detection, simplifying the diagnostic process and increasing patient treatment outcomes[2].

Key Takeaways

  • Clinical Trials: Tc 99m PYP has shown high efficacy in detecting ATTR cardiac amyloidosis and acute myocardial infarction.
  • Market Size: The Technetium-99m market was valued at USD 4.95 billion in 2023 and is expected to grow to USD 6.54 billion by 2030.
  • Market Drivers: Advancements in radiopharmaceuticals, increasing diagnostic procedures, and healthcare infrastructure expansion are key drivers.
  • Challenges: Complex supply chain, regulatory issues, and financial struggles of older nuclear reactors are significant challenges.
  • Future Projections: Continued growth in demand, especially in emerging markets, and ongoing innovations in Tc-99m-based radiopharmaceuticals.

FAQs

What is the primary use of Technetium Tc-99m Pyrophosphate Kit?

The primary use of Technetium Tc-99m Pyrophosphate Kit is for skeletal and cardiac imaging, particularly for detecting areas of altered osteogenesis and acute myocardial infarction.

What are the key drivers of the Technetium-99m market growth?

The key drivers include advancements in radiopharmaceuticals, increasing diagnostic procedures, and the expansion of healthcare infrastructure.

What are the challenges facing the Technetium-99m market?

The market faces challenges due to its complex and delicate supply chain, regulatory issues, and financial struggles of older nuclear reactors.

How is Technetium Tc-99m Pyrophosphate used in cardiac amyloidosis detection?

Technetium Tc-99m Pyrophosphate is used in planar cardiac imaging to detect transthyretin cardiac amyloidosis with high sensitivity and specificity.

What is the expected market size of Technetium-99m by 2030?

The Technetium-99m market is expected to reach nearly USD 6.54 billion by 2030.

Sources

  1. Technescan™ PYP™ Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection - FDA Label[1]
  2. Technetium-99m Market: Global Industry Analysis and Forecast (2024-2030) - Maximize Market Research[2]
  3. Technetium-99m Market Size, Share, Growth & Overview, 2034 - Transparency Market Research[3]
  4. Multicenter Study of Planar Technetium 99m Pyrophosphate Cardiac Imaging for Detecting Transthyretin Cardiac Amyloidosis - JAMA Cardiology[4]
  5. Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection - DailyMed[5]

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