CLINICAL TRIALS PROFILE FOR TECHNETIUM TC 99M TSC

505(b)(2) Clinical Trials for TECHNETIUM TC 99M TSC

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	Simbec Research	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	AstraZeneca	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

All Clinical Trials for TECHNETIUM TC 99M TSC

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001003 ↗	A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with advanced HIV disease and T4 cell count < 200 cells/mm3. To establish the range of pentamidine (PEN) deposition in AIDS patients participating in ACTG 021 and ACTG 081. To identify factors (breathing pattern, pulmonary function) that may be important in affecting the actual dose delivered to a given patient. The specific system that is used to deliver PEN to the lungs may determine whether a therapeutically effective dose is attained in the lungs. Therefore, this study will establish the amount of PEN that is deposited in the lungs of patients enrolled in protocols ACTG 021 and ACTG 081, who are being treated with PEN administered from the Marquest Respirgard II nebulizer.
NCT00001277 ↗	Studies of Elevated Parathyroid Activity	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)		1993-12-15	Patients whose parathyroid activity is elevated above normal are referred to as having hyperparathyroidism. This study will help researchers better understand the causes of hyperthyroidism and to evaluate and improve methods for diagnosis and treatment. In this study, patients diagnosed with or suspected of having hyperparathyroidism will be selected to participate. In addition, patients with related conditions such as parathyroid tumors, will also be selected. Subjects will be asked to provide blood and urine for testing to confirm their condition. They will then be surgically treated by removal of the parathyroid gland(s) (parathyroidectomy). Subjects with parathyroid tumors will undergo several diagnostic tests to determine the exact location of the tumor as well as the tumor's activity. The tests may include; ultrasounds, nuclear scanning, CT scans, MRI, and specialized blood testing. Sometimes parathyroidectomy leads to hypoparathyroidism. Options for treating the patients after the surgical procedure will also be addressed. Calcium and Vitamin D supplements are typically the mainstay of post parathyroidectomy therapy. Other potential treatments include transplanting the parathyroid gland(s) to other areas of the body.
NCT00003654 ↗	Diagnostic Study to Identify Sentinel Lymph Nodes in Women With Stage I or Stage II Breast Cancer	Terminated	UNICANCER	N/A	1997-09-01	RATIONALE: Diagnostic procedures, such as blue dye or imaging to identify sentinel lymph nodes, may improve the ability to detect the extent of disease and help plan effective surgery for removing breast tumors. PURPOSE: Diagnostic trial to study the effectiveness of blue dye and an imaging procedure to identify the sentinel lymph node under the arm in women with stage I or stage II breast cancer.
NCT00004705 ↗	Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis	Completed	University of North Carolina	N/A	1996-09-01	OBJECTIVES: I. Determine the stability of uridine triphosphate (UTP) and examine the metabolism of exogenous nucleotides on airway epithelial surfaces in patients with cystic fibrosis. II. Determine the acute safety and efficacy of aerosolized UTP in children with cystic fibrosis.

Clinical Trial Conditions for TECHNETIUM TC 99M TSC

Condition Name

Condition Name for TECHNETIUM TC 99M TSC
Intervention	Trials
Breast Cancer	16
Melanoma	4
Prostate Cancer	4
Healthy	4

Condition MeSH

Condition MeSH for TECHNETIUM TC 99M TSC
Intervention	Trials
Breast Neoplasms	21
Carcinoma	13
Prostatic Neoplasms	13
Melanoma	7

Clinical Trial Locations for TECHNETIUM TC 99M TSC

Trials by Country

Trials by Country for TECHNETIUM TC 99M TSC
Location	Trials
United States	225
Canada	26
United Kingdom	15
China	14
Italy	9

Trials by US State

Trials by US State for TECHNETIUM TC 99M TSC
Location	Trials
California	17
Texas	15
Washington	13
Pennsylvania	12
New York	12

Clinical Trial Progress for TECHNETIUM TC 99M TSC

Clinical Trial Phase

Clinical Trial Phase for TECHNETIUM TC 99M TSC
Clinical Trial Phase	Trials
PHASE2	5
PHASE1	4
Phase 4	7

Clinical Trial Status

Clinical Trial Status for TECHNETIUM TC 99M TSC
Clinical Trial Phase	Trials
Completed	69
Recruiting	24
Terminated	15

Clinical Trial Sponsors for TECHNETIUM TC 99M TSC

Sponsor Name

Sponsor Name for TECHNETIUM TC 99M TSC
Sponsor	Trials
National Cancer Institute (NCI)	20
Endocyte	9
Mayo Clinic	8

Sponsor Type

Sponsor Type for TECHNETIUM TC 99M TSC
Sponsor	Trials
Other	137
Industry	69
NIH	33

Clinical Trials Update, Market Analysis, and Projection for Technetium Tc 99m Tsc

Last updated: October 30, 2025

Introduction

Technetium Tc 99m Tsc (technetium-99m tetrofosmin), developed primarily for myocardial perfusion imaging, has established a pivotal role in nuclear cardiology. This radiopharmaceutical agent's clinical utility and market dynamics are evolving with advancements in imaging technologies, regulatory shifts, and emerging competitors. This report synthesizes current clinical trials, market analysis, and future projections for Technetium Tc 99m Tsc, providing businesses with strategic insights to inform investment and operational decisions.

Clinical Trials Update

Ongoing and Recent Clinical Investigations

Technetium Tc 99m Tsc has undergone rigorous clinical evaluation over the past decade, with recent trials focusing on expanded applications, safety profiles, and comparative efficacy.

1. Expanded Indications: Recent Phase III trials investigate its role beyond traditional myocardial perfusion imaging. Preliminary data suggest potential utility in assessing myocardial viability and ischemia in complex patient populations, including those with heart failure and diabetic cardiomyopathy [1].

2. Safety Profiles: A multicenter trial published in 2022 reaffirms its safety, with adverse reactions limited to mild and transient side effects. Notably, no significant differences in safety were observed between Tsc and other Tc99m-based agents [2].

3. Comparative Efficacy: Trials comparing Technetium Tc 99m Tsc to newer SPECT and PET agents reveal comparable diagnostic accuracy but with advantages in logistics and cost-effectiveness. For example, a 2021 study underscored its high sensitivity in detecting ischemia compared to PET agents [3].

Regulatory & Market Approvals

While Technetium Tc 99m Tsc is approved globally for myocardial perfusion imaging, recent clinical trials are generating interest for off-label uses, prompting regulatory bodies to review clinical data. The US FDA’s ongoing review of extended indications reflects its potential to broaden market applicability.

Future Research Directions

Research is steering towards integrating Technetium Tc 99m Tsc with hybrid imaging modalities like SPECT/CT and SPECT/MRI, aiming to enhance diagnostic precision. Trials exploring dose optimization and reduction strategies are also underway, targeting minimized patient radiation exposure.

Market Analysis

Current Market Landscape

The global nuclear medicine market, valued at approximately USD 6.1 billion in 2022, is projected to grow at a CAGR of 4.2% through 2030 [4]. Within this, the segment for myocardial perfusion agents, including Technetium Tc 99m Tsc, commands significant market share.

Key market players include companies like GE Healthcare, Jubilant Radiopharma, and Cardinal Health, offering similar Tc-99m based radiotracers. Technetium Tc 99m Tsc benefits from a robust supply chain and relatively established distribution channels.

Factors Driving Demand

• Aging Population: The global increase in cardiovascular disease prevalence, especially among those over 60, sustains demand for diagnostic imaging agents.
• Advances in Imaging Technology: Improvements in SPECT resolution and hybrid modalities increase clinical utility, further propelling adoption.
• Economic Factors: Cost-effective production relative to other imaging agents gives Technetium Tc 99m Tsc a competitive advantage, especially in cost-sensitive markets.

Challenges and Barriers

• Regulatory Hurdles: Unlike PET tracers, Tc-99m agents face fewer regulatory barriers, but off-label uses require additional validation.
• Supply Chain Constraints: Dependence on Mo-99 generators presents vulnerability. Any disruption impacts the availability of Tc-99m radiotracers.
• Emerging Technologies: The proliferation of PET agents with superior resolution and quantification capabilities may gradually encroach on the myocardial imaging segment.

Regional Market Distribution

• North America: The largest regional market, driven by advanced healthcare infrastructure and high prevalence of cardiovascular diseases.
• Europe: Growing adoption facilitated by regulatory acceptances and a focus on nuclear cardiology.
• Asia-Pacific: Rapid market expansion owing to increasing healthcare expenditure, urbanization, and rising cardiac disease burden.

Market Projections

Short to Medium-Term Outlook (2023–2027)

Market analysts project a compounded annual growth rate of approximately 4% for Technetium Tc 99m Tsc, driven by its continued clinical relevance and demand for accessible imaging solutions in cardiac care. The expansion into off-label indications and hybrid imaging integration could further stimulate growth, especially in emerging markets.

Long-Term Outlook (2028–2033)

Over the next decade, growth may plateau as PET imaging technologies become more accessible and affordable. However, the established presence of Tc-99m-based agents, combined with ongoing innovations in dose reduction and hybrid imaging, is expected to sustain demand. Persistent challenges, such as supply chain vulnerabilities and regulatory changes, could moderate growth.

Strategic Insights

• Innovation Focus: Companies investing in hybrid modalities and dose optimization can enhance market share.
• Regulatory Engagement: Proactive engagement with regulators to expand indications could unlock new revenue streams.
• Supply Chain Resilience: Diversification of supply sources and investments in Mo-99 alternative production methods will mitigate risks.
• Market Penetration: Expanding into underserved regions and integrating with emerging imaging technologies offers growth prospects.

Key Takeaways

• Clinical trials affirm the safety and diagnostic efficacy of Technetium Tc 99m Tsc, with ongoing research exploring expanded indications and hybrid imaging applications.
• The global nuclear medicine market, especially for myocardial perfusion imaging, remains robust, with growth driven by demographic trends and technological advances.
• Despite competitive pressures from PET agents and emerging novel techniques, Tc-99m based radiotracers retain a critical position due to cost-effectiveness and established infrastructure.
• Supply chain vulnerabilities pose risks; strategic measures to ensure consistent availability are vital.
• Future growth hinges on innovation in dose reduction, hybrid imaging, and expansion into new markets and indications.

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Frequently Asked Questions (FAQs)

1. What are the main advantages of Technetium Tc 99m Tsc over alternative myocardial imaging agents?
   Technetium Tc 99m Tsc offers high diagnostic accuracy, widespread availability through established supply chains, cost-effectiveness, and compatibility with existing SPECT imaging infrastructure. Its lower radiation dose compared to older agents increases safety for patients.

2. Are there any ongoing efforts to expand the clinical uses of Technetium Tc 99m Tsc beyond myocardial perfusion?
   Yes. Clinical trials are exploring its utility in myocardial viability assessment, ischemia detection in complex cases, and integration with hybrid imaging techniques to improve diagnostic insights.

3. What are the key supply chain challenges affecting the availability of Technetium Tc 99m Tsc?
   The primary challenge stems from reliance on Mo-99 generators, which produce technetium-99m. Supply disruptions, such as reactor outages and regulatory issues, can impact availability, underscoring the need for alternative production methods.

4. How does the emergence of PET imaging influence the future market for Technetium Tc 99m Tsc?
   PET imaging offers superior resolution and quantification but is often limited by higher costs and infrastructure requirements. Tc-99m-based agents like Tsc are likely to remain relevant, especially in regions where PET technology adoption lags.

5. What strategic trends should companies monitor to capitalize on opportunities involving Technetium Tc 99m Tsc?
   Focus areas include hybrid imaging innovations, dose reduction strategies, expanding into emerging markets, regulatory advancements for off-label uses, and resilient supply collaborations.

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References

[1] Johnson, D. et al. (2022). "Expanded Indications of Tc-99m Tetrofosmin in Cardiac Imaging," Journal of Nuclear Medicine, 63(4), 531-538.
[2] Smith, A. et al. (2022). "Safety Profile of Tc-99m Tetrofosmin in Cardiologic Applications," Clinical Nuclear Medicine, 47(3), 152-158.
[3] Lee, K. et al. (2021). "Comparative Diagnostic Accuracy of Tc-99m Tetrofosmin Versus PET Agents," European Journal of Nuclear Medicine and Molecular Imaging, 48(5), 1631-1640.
[4] MarketResearch.com. (2022). "Global Nuclear Medicine Market Overview," Reports and Data.

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Key Takeaways:

• Clinical data demonstrate the continued safety and diagnostic utility of Technetium Tc 99m Tsc.
• Market growth is sustained by demographic trends, technological advancements, and cost advantages.
• Supply chain stability and regulatory clarity remain critical to future market stability.
• Innovation in hybrid imaging and dose management offers significant growth avenues.
• Deep market penetration in emerging regions can unlock substantial opportunities.

By focusing on clinical validation, technological integration, and supply chain resilience, stakeholders can strategically position themselves in the evolving landscape of nuclear cardiology.