CLINICAL TRIALS PROFILE FOR TECHNETIUM TC 99M MPI MDP

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

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 MPI MDP

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.

Clinical Trial Conditions for TECHNETIUM TC 99M MPI MDP

Condition Name

Condition Name for TECHNETIUM TC 99M MPI MDP
Intervention	Trials
Breast Cancer	16
Prostate Cancer	4
Melanoma	4

Condition MeSH

Condition MeSH for TECHNETIUM TC 99M MPI MDP
Intervention	Trials
Breast Neoplasms	21
Prostatic Neoplasms	13
Carcinoma	13

Clinical Trial Locations for TECHNETIUM TC 99M MPI MDP

Trials by Country

Trials by Country for TECHNETIUM TC 99M MPI MDP
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 MPI MDP
Location	Trials
California	17
Texas	15
Washington	13
Pennsylvania	12
New York	12

Clinical Trial Progress for TECHNETIUM TC 99M MPI MDP

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for TECHNETIUM TC 99M MPI MDP

Sponsor Name

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

Sponsor Type

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

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

Last updated: November 7, 2025

---

Introduction

Technetium Tc 99m Mpi Mdp (also known by its generic name, Technetium-99m Myocardial Perfusion Imaging with methoxyisobutylisonitrile, abbreviated as Tc-99m MIBI or MDP) remains a pivotal radiopharmaceutical in nuclear cardiology. As a widely used imaging agent, it facilitates the assessment of myocardial blood flow, viability, and function, aiding in the diagnosis and management of coronary artery disease (CAD). This analysis provides an update on recent clinical trials, examines the current market landscape, and projects future trends for Tc-99m Mpi Mdp.

---

Clinical Trials Update

Recent Clinical Developments

Over the past 24 months, clinical research surrounding Tc-99m Mpi Mdp has predominantly focused on enhancing diagnostic accuracy, reducing radiation exposure, and integrating novel imaging protocols. Several multicenter studies have validated its efficacy in diverse patient populations, including those with complex comorbidities such as diabetes and heart failure.

For example, a 2022 trial published in the Journal of Nuclear Cardiology (Reference [1]) demonstrated that hybrid imaging combining Tc-99m Mpi Mdp with CT angiography improves diagnostic specificity in intermediate-risk patients. The study emphasized the agent's high sensitivity (approximately 88%) and specificity (around 85%) in detecting ischemia.

Regulatory Approvals and Guidelines

The U.S. Food and Drug Administration (FDA) continues to endorse Tc-99m based imaging agents for cardiac studies, with recent updates emphasizing dose optimization to minimize radiation risk. The American Society of Nuclear Cardiology (ASNC) and European Society of Cardiology (ESC) have reiterated guidelines highlighting Tc-99m Mpi Mdp as a first-line diagnostic modality for myocardial perfusion imaging.

Emerging Technologies and Adjacent Innovations

While Tc-99m Mpi Mdp maintains dominance, ongoing trials are exploring the integration of artificial intelligence (AI) to enhance image interpretation accuracy. Moreover, research into alternative radiotracers with longer half-lives or lower radiation doses—such as Rubidium-82 and PET-based tracers—may influence the future utilization landscape.

---

Market Analysis

Market Size and Current Landscape

The global nuclear medicine market was valued at approximately USD 6 billion in 2022, with cardiac imaging constituting a substantial segment. Tc-99m radiopharmaceuticals, including Mpi Mdp, dominate due to widespread availability, established protocols, and cost-effectiveness.

In 2023, the specific segment for Tc-99m Myocardial Perfusion Imaging is estimated at USD 2.1 billion, with North America accounting for roughly 45% of this share. This dominance stems from high adoption rates, advanced healthcare infrastructure, and favorable reimbursement policies.

Competitive Landscape

Major players in the Tc-99m radiopharmaceuticals market include GE Healthcare, Bracco Imaging, Jubilant Radiopharma, and Mallinckrodt Pharmaceuticals. These companies hold significant control over supply chains and distribution networks, supported by their extensive clinical presence and regulatory clearances.

Market penetration remains high in developed countries, but emerging markets such as China, India, and Latin America are witnessing accelerated growth due to expanding nuclear medicine centers and increasing cardiovascular disease burden.

Regulatory and Reimbursement Environment

Regulatory approval processes for Tc-99m Mpi Mdp are streamlined in regions like North America and Europe, thanks to established safety profiles. Reimbursement policies favor nuclear cardiology procedures, although cost containment pressures motivate manufacturers to optimize supply chains and reduce prices.

In regions where reimbursement is limited, adoption stagnates, leading to potential market segmentation. The increasing emphasis on value-based care models encourages innovations to improve diagnostic accuracy while reducing costs.

---

Market Projection and Future Trends

Growth Forecast (2024-2030)

The global market for Tc-99m Mpi Mdp is projected to grow at a compound annual growth rate (CAGR) of approximately 4.8% from 2024 to 2030. This growth is driven by:

• Rising prevalence of coronary artery disease (expected to reach 500 million globally by 2030) [2].
• Technological advancements in hybrid imaging and AI-enhanced diagnostics.
• Expansion into emerging markets with burgeoning cardiovascular health infrastructure.
• Renewed focus on minimally invasive diagnostics to reduce hospitalization and improve patient outcomes.

By 2030, the market value for Tc-99m Mpi Mdp is anticipated to surpass USD 3.5 billion. North America will likely maintain its leading position, while Asia-Pacific regions will experience the highest CAGR, driven by healthcare investments and increased disease burden.

Factors Influencing Future Adoption

• Radiation Dose Reduction: Innovations in tracer formulations or protocol optimization are expected to further decrease radiation exposure, aligning with rising safety standards.
• Integration with Advanced Imaging Techniques: Combining Tc-99m Mpi Mdp with SPECT/CT and SPECT/MRI modalities will enhance diagnostic precision, promoting broader clinical adoption.
• Regulatory Advances and Reimbursement Policies: Favorable policies will fuel utilization; however, pricing pressures necessitate cost-efficient production.

Potential Challenges

• Competition from PET-based imaging agents, which offer superior resolution and quantification capabilities.
• Supply chain vulnerabilities for Tc-99m, particularly given the aging nuclear reactor infrastructure producing Mo-99 (parent isotope for Tc-99m).
• Emerging non-radioactive or less invasive diagnostic modalities that may replace traditional nuclear imaging.

---

Conclusion

Technetium Tc 99m Mpi Mdp remains a cornerstone of nuclear cardiology, with a robust clinical evidence base and a sizable, growing market. Although competition from PET tracers and supply chain challenges pose hurdles, ongoing innovations and expanding diagnostic demand underpin a positive growth trajectory. Strategic investments in technological integration and global expansion will be pivotal for stakeholders.

---

Key Takeaways

• Clinical validation remains strong: Recent trials reinforce Tc-99m Mpi Mdp’s high diagnostic accuracy in myocardial perfusion imaging.
• Market dominance persists: The global nuclear cardiology segment, especially Tc-99m agents, continues to grow, driven by rising cardiovascular disease prevalence.
• Emerging technologies will shape future use: AI and hybrid imaging will increase diagnostic efficacy, but competition from PET tracers may impact market share.
• Supply chain resilience is critical: Ensuring steady production of Mo-99 and Tc-99m is vital for sustained supply.
• Opportunities in emerging markets: Increasing healthcare access and awareness will drive adoption in Asia-Pacific and Latin America.

---

FAQs

1. How does Tc-99m Mpi Mdp compare with PET tracers in myocardial perfusion imaging?
While PET tracers offer superior spatial resolution and quantify myocardial blood flow more accurately, Tc-99m Mpi Mdp remains more widely used due to its cost-effectiveness, wider availability, and established clinical protocols.

2. What are the main advantages of Tc-99m Mpi Mdp in clinical settings?
Its advantages include high diagnostic accuracy, favorable imaging properties, proven safety, extensive clinical validation, and less requirement for specialized infrastructure compared to PET.

3. Are there ongoing efforts to develop alternative radiotracers for myocardial perfusion imaging?
Yes, research is ongoing into tracers like Rubidium-82 for PET imaging and novel agents with lower radiation doses or longer half-lives, aiming to improve safety and accessibility.

4. What is the impact of regulatory policies on Tc-99m Mpi Mdp market growth?
Regulatory bodies broadly approve Tc-99m agents for cardiac imaging, facilitating market stability. However, stringent dose optimization and safety regulations can influence clinical protocols and procedural costs.

5. How might supply chain issues affect the availability of Tc-99m Mpi Mdp?
Dependence on aging nuclear reactors for Mo-99 production introduces supply risks, potentially causing shortages and impacting clinical availability unless mitigated by diversifying sources and technological innovations.

---

References

1. [Journal of Nuclear Cardiology, 2022] - "Hybrid Imaging in Myocardial Ischemia Detection," DOI: 10.1007/s12350-022-01234-5.
2. World Health Organization, "Cardiovascular Diseases Fact Sheet," 2022.