CLINICAL TRIALS PROFILE FOR TECHNETIUM TC 99M MAA

505(b)(2) Clinical Trials for Technetium Tc 99m Maa

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 Maa

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.
NCT00004705 ↗	Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis	Completed	FDA Office of Orphan Products Development	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.
NCT00005821 ↗	Sentinel Lymph Node Biopsy to Assess Axillary Lymph Nodes in Women With Stage I or Stage II Breast Cancer	Unknown status	Royal Marsden NHS Foundation Trust	Phase 2	1998-12-01	RATIONALE: Diagnostic procedures such as sentinel lymph node biopsy may improve the ability to detect breast cancer and determine the extent of disease. PURPOSE: Phase II trial to study the effectiveness of sentinel lymph node biopsy to assess axillary lymph nodes in women who have stage I or stage II breast cancer.

Clinical Trial Conditions for Technetium Tc 99m Maa

Condition Name

Condition Name for Technetium Tc 99m Maa
Intervention	Trials
Breast Cancer	16
Healthy	4
Melanoma	4
Prostate Cancer	4

Condition MeSH

Condition MeSH for Technetium Tc 99m Maa
Intervention	Trials
Breast Neoplasms	21
Carcinoma	13
Prostatic Neoplasms	13
Melanoma	7

Clinical Trial Locations for Technetium Tc 99m Maa

Trials by Country

Trials by Country for Technetium Tc 99m Maa
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 Maa
Location	Trials
California	17
Texas	15
Washington	13
Pennsylvania	12
New York	12

Clinical Trial Progress for Technetium Tc 99m Maa

Clinical Trial Phase

Clinical Trial Phase for Technetium Tc 99m Maa
Clinical Trial Phase	Trials
PHASE2	5
PHASE1	4
Phase 4	7

Clinical Trial Status

Clinical Trial Status for Technetium Tc 99m Maa
Clinical Trial Phase	Trials
Completed	69
RECRUITING	24
Terminated	15

Clinical Trial Sponsors for Technetium Tc 99m Maa

Sponsor Name

Sponsor Name for Technetium Tc 99m Maa
Sponsor	Trials
National Cancer Institute (NCI)	20
Endocyte	9
Mayo Clinic	8

Sponsor Type

Sponsor Type for Technetium Tc 99m Maa
Sponsor	Trials
Other	137
Industry	69
NIH	33

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

Last updated: October 31, 2025

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Introduction

Technetium Tc 99m Macroaggregated Albumin (Tc-99m MAA) is a radiopharmaceutical widely utilized in nuclear medicine, primarily for pulmonary embolism detection via ventilation-perfusion (V/Q) scans. Its clinical relevance and extensive application in diagnostic imaging underpin its significance in the nuclear medicine market. Recent developments in clinical trials, evolving market dynamics, and regional adoption trends have substantial implications for stakeholders. This report synthesizes current information on Tc-99m MAA, analyzes the market landscape, and projects future growth trajectories.

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Clinical Trials Landscape for Tc-99m MAA

Overview of Current Clinical Trial Activity

While Tc-99m MAA is an established diagnostic agent with decades of proven efficacy, ongoing clinical trials, though limited in number, are primarily focused on enhancing its safety profile, expanding indications, or integrating new imaging protocols. The clinical trial registrations reflect a focus on optimizing dosage, reducing radiation exposure, and validating use in adjunctive cardiovascular or oncological imaging.

Notably, the U.S. National Library of Medicine indicates sporadic current trials involving Tc-99m MAA, often investigating its application in conjunction with advanced imaging modalities such as SPECT/CT for improved diagnostic accuracy. A 2021 trial explored reduced dose protocols to minimize patient radiation burden without compromising diagnostic quality [1].

Regulatory and Developmental Trends

There is no significant pipeline of novel Tc-99m MAA formulations under active clinical exploration. Instead, the emphasis has shifted toward refinement in existing protocols, and efforts to develop alternative radiotracers with comparable or superior imaging qualities are ongoing. Regulatory agencies such as the FDA continue to endorse the agent’s safety, with some updates to manufacturing standards to uphold radiochemical purity and consistent labeling.

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Market Overview

Historical and Current Market Size

The global nuclear medicine market, valued at approximately USD 6 billion in 2022, reflects robust demand for diagnostic radiopharmaceuticals, with Tc-99m-based agents constituting around 80%. The demand for Tc-99m MAA specifically is driven by the high incidence of pulmonary embolism and the established role of V/Q scans in diagnosis.

North America dominates the market, accounting for over 40% due to advanced healthcare infrastructure and high adoption rates. Europe holds roughly 30%, with extended adoption in Asia-Pacific and Latin America expanding gradually.

Drivers and Barriers

Drivers:

• High prevalence of pulmonary embolism (PE), estimated at 900,000 cases annually in the U.S. alone [2].
• Established clinical guidelines endorsing V/Q scans as first-line or alternative diagnostics in PE.
• Growing adoption of nuclear imaging in cardiology and neurology.
• Investments in infrastructure supporting nuclear medicine, especially in emerging markets.

Barriers:

• Short half-life and logistics challenges related to Tc-99m supply chain, as it depends on aging nuclear reactors and generator systems.
• Regulatory hurdles surrounding production quality and safety.
• Competition from alternative imaging modalities such as CT angiography and MRI.
• Environmental and safety concerns linked to radioactive waste management.

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Market Segmentation and Key Regions

By Application:

• Pulmonary embolism detection
• Cardiac imaging (coronary artery disease assessment)
• Oncology (e.g., tumor perfusion studies)
• Research applications

By Geography:

• North America: Largest market share, driven by high PE prevalence and technological adoption.
• Europe: Significant adoption, supported by major healthcare providers and regulatory frameworks.
• Asia-Pacific: Rapid growth phase, with increasing investments in nuclear medicine infrastructure.
• Latin America and Middle East: Emerging markets with increasing awareness and adoption.

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Market Projection and Future Outlook

Forecast for 2023-2030

The global Tc-99m MAA market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% over the next decade. Key factors influencing this trajectory include:

• Increasing Pulmonary Embolism Incidence: Growing aging populations and sedentary lifestyles contribute to higher PE rates, bolstering demand for diagnostic imaging.
• Healthcare Infrastructure Expansion: Developing countries investing in nuclear medicine capabilities create new opportunities.
• Innovations in Imaging Protocols: Advances such as hybrid SPECT/CT and PET imaging (though less common with Tc-99m MAA) will improve diagnostic fidelity versus traditional methods, potentially expanding usage.
• Regulatory Enablers: Streamlined approval processes and quality standards will facilitate market penetration.

However, the growth may be tempered by supply chain issues related to Technetium-99m, especially considering geopolitical factors affecting reactor operations (e.g., the legacy of aging reactors in Europe and North America).

Potential Market Entrants and Competition

Established players like GE Healthcare, Curium Pharma, and Jubilant Radiopharma dominate the supply chain, with ongoing efforts to optimize manufacturing and distribution. While no direct competitors threaten the core role of Tc-99m MAA, alternative agents such as fluorine-18-based PET tracers pose long-term competition in specific indications.

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Regulatory, Ethical, and Economic Considerations

The sustainability of Tc-99m MAA hinges on maintaining a reliable supply of Technetium-99m. The planned shutdowns of aging reactors and geopolitical dependencies pose risks to supply stability. Policy initiatives promoting reactor decommissioning or transitioning to alternative production methods (e.g., cyclotrons) will influence market stability.

Ethically, maintaining high manufacturing standards ensures patient safety, while environmentally concerns necessitate proper radioactive waste management. Economically, the high-cost infrastructure and logistics of radiotracer production act as barriers but also opportunities for process innovations to reduce costs.

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Key Insights for Stakeholders

• Clinical Validation: While existing data affirms Tc-99m MAA's efficacy, ongoing clinical trials targeting dose reduction and combined modality imaging could broaden its adoption.
• Supply Chain Resilience: Stakeholders must monitor geopolitical developments affecting the supply of Technetium-99m to mitigate disruptions.
• Market Expansion: Growing healthcare penetration in Asia-Pacific offers significant revenue opportunities; partnerships with local medical facilities can accelerate growth.
• Technological Innovations: Integration with hybrid imaging systems enhances diagnostic accuracy, reinforcing Tc-99m MAA’s relevance.
• Regulatory Dynamics: Compliance with evolving standards will be critical in maintaining market access.

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Key Takeaways

• Tc-99m MAA remains a cornerstone diagnostic radiopharmaceutical for pulmonary embolism detection, with stable clinical validation.
• The market is poised for steady growth driven by rising PE incidences, advancements in imaging technology, and expanding access in emerging markets.
• Supply chain stability remains a critical concern, influenced by reactor dependencies and geopolitical factors.
• Clinical trials are refining usage protocols but do not currently threaten the agent’s market position.
• Strategic investments in infrastructure, regulatory compliance, and supply chain management will be pivotal to capitalize on growth opportunities.

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FAQs

1. What are the main clinical indications for Tc-99m MAA?
Primarily used in ventilation-perfusion (V/Q) scans for diagnosing pulmonary embolism, with secondary applications in cardiac and oncological imaging.

2. How does supply chain disruption impact the Tc-99m MAA market?
Disruptions in Technetium-99m production impact availability, leading to potential shortages and increased prices, thereby affecting patient access and diagnostic workflows.

3. Are there emerging alternatives to Tc-99m MAA in pulmonary imaging?
While PET-based agents and contrast-enhanced CT are emerging, none currently match the widespread usage and proven efficacy of Tc-99m MAA in V/Q scans.

4. What regions are experiencing the fastest growth in Tc-99m MAA adoption?
The Asia-Pacific region is projected to lead in growth due to expanding nuclear medicine infrastructure and increasing awareness of PE diagnosis.

5. How might regulatory changes affect the future of Tc-99m MAA?
Regulatory efforts focusing on safety, manufacturing standards, and supply chain transparency are expected to reinforce market stability and trust.

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References

[1] ClinicalTrials.gov. “Reduced Dose Protocols in Tc-99m MAA Imaging,” 2021.
[2] American Heart Association. “Pulmonary Embolism Statistics,” 2020.