CLINICAL TRIALS PROFILE FOR MPI DTPA KIT - CHELATE

All Clinical Trials for MPI DTPA KIT - CHELATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00440583 ↗	The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP	Completed	Bayer	Phase 2	2006-09-01	The purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial remission after 6 cycles of CHOP therapy.
NCT00440583 ↗	The Response Study of Yt90-Zevalin in Patients With Diffuse Large B-cell Lymphoma After 6 Cycles of CHOP	Completed	Mahidol University	Phase 2	2006-09-01	The purpose of this study is to determine the effective of Yt90-Zevalin therapy in patients with diffuse large B-cell lymphoma that have achieved at least an unconfirmed partial remission after 6 cycles of CHOP therapy.
NCT00461149 ↗	Dose Escalation of Octreotide-LAR as First-Line Therapy in Resistant Acromegaly	Completed	Federico II University	Phase 4	1995-01-01	Epidemiological data indicate that patients with active acromegaly have reduced life expectancy because of cardiovascular (60%) and respiratory diseases (25%) mainly (1-10). A post-treatment GH value
NCT00602316 ↗	Multifunctional Magnetic Resonance Imaging in Predicting Breast Lesions in Women Undergoing Mastectomy for Breast Cancer	Unknown status	Royal Marsden NHS Foundation Trust	N/A	2007-11-01	RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging, may help doctors learn the extent of disease and plan the best treatment. PURPOSE: This clinical trial is studying how well multifunctional magnetic resonance imaging works in predicting breast lesions in women undergoing mastectomy for breast cancer.
NCT01059474 ↗	Transdermal Absorption of Dimercaptopropane-1-Sulfonate (DMPS) and Effect on Urinary Mercury Excretion	Completed	Phoenix Children's Hospital	Phase 1	2010-04-01	DMPS is a metal chelator which is approved for use in Europe. While not an FDA-approved drug in the US, it is easily obtained and administered by alternative health practitioners to their patients. A formulation called 'TD DMPS' (transdermal DMPS) is in use, despite the fact there is no published literature to support that the agent is absorbed transdermally. The investigators hypothesis is that DMPS is not absorbed through the skin. The investigators plan to apply TD DMPS to healthy volunteers and then test serum for presence of DMPS. In addition the investigators will measure urinary mercury concentrations pre and post DMPS application.
NCT01059474 ↗	Transdermal Absorption of Dimercaptopropane-1-Sulfonate (DMPS) and Effect on Urinary Mercury Excretion	Completed	Banner Health	Phase 1	2010-04-01	DMPS is a metal chelator which is approved for use in Europe. While not an FDA-approved drug in the US, it is easily obtained and administered by alternative health practitioners to their patients. A formulation called 'TD DMPS' (transdermal DMPS) is in use, despite the fact there is no published literature to support that the agent is absorbed transdermally. The investigators hypothesis is that DMPS is not absorbed through the skin. The investigators plan to apply TD DMPS to healthy volunteers and then test serum for presence of DMPS. In addition the investigators will measure urinary mercury concentrations pre and post DMPS application.
NCT01160198 ↗	A Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate.	Completed	GlaxoSmithKline	Phase 3	2010-10-13	Iron deficiency anaemia (Haemoglobin, Hb < 12gm/dl) is one of India's major public health problems particularly in women. Effective control of iron deficiency anaemia decreases the incidence of fatigue, bodyache, headache, lack of concentration and menstrual complications. Iron bisglycine chelate has been used successfully to treat iron deficiency anaemia and is also a well tolerated therapy. Use of ferrous bisglycinate chelate one tablet daily as a nutritional supplement is well established in India. For treatment of iron deficiency anaemia, some women may need 1 tablet/day, while some may need 2 tablets/day. In India, ferrous ascorbate, 1 tablet daily is a widely accepted form of treatment for iron deficiency anaemia. The primary purpose of this study is to demonstrate the efficacy and tolerability profile of ferrous bisglycinate chelate to support the registration of this product as a 'drug' in India. Comparative data between ferrous bisglycinate chelate and ferrous ascorbate will also augment our existing knowledge, which will further support appropriate use of ferrous bisglycinate chelate for the treatment of iron deficiency anaemia. Study design and patient population: This will be a multicentre, randomized, laboratory-blinded, parallel- group study. It is projected that the study will randomize 270 women (90 subjects in each treatment arm) with iron deficiency anaemia (Hb 6-9 gm/dl + serum Ferritin

Clinical Trial Conditions for MPI DTPA KIT - CHELATE

Condition Name

Condition Name for MPI DTPA KIT - CHELATE
Intervention	Trials
Covid19	3
Iron Deficiency Anemia	3
COVID-19	2
Prosthetic-joint Infection	1

Condition MeSH

Condition MeSH for MPI DTPA KIT - CHELATE
Intervention	Trials
COVID-19	5
Anemia, Iron-Deficiency	5
Anemia	5
Deficiency Diseases	4

Clinical Trial Locations for MPI DTPA KIT - CHELATE

Trials by Country

Trials by Country for MPI DTPA KIT - CHELATE
Location	Trials
United States	30
Japan	14
Italy	9
Germany	7
China	5

Trials by US State

Trials by US State for MPI DTPA KIT - CHELATE
Location	Trials
Ohio	3
Missouri	3
California	3
South Carolina	2
Maryland	2

Clinical Trial Progress for MPI DTPA KIT - CHELATE

Clinical Trial Phase

Clinical Trial Phase for MPI DTPA KIT - CHELATE
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	7
Phase 3	7

Clinical Trial Status

Clinical Trial Status for MPI DTPA KIT - CHELATE
Clinical Trial Phase	Trials
Completed	17
Unknown status	5
Not yet recruiting	3

Clinical Trial Sponsors for MPI DTPA KIT - CHELATE

Sponsor Name

Sponsor Name for MPI DTPA KIT - CHELATE
Sponsor	Trials
National Cancer Institute (NCI)	2
Bayer	2
Replicor Inc.	2

Sponsor Type

Sponsor Type for MPI DTPA KIT - CHELATE
Sponsor	Trials
Other	28
Industry	15
NIH	2

Clinical Trials Update, Market Analysis, and Projection for MPI DTPA Kit – Chelate

Last updated: November 1, 2025

---

Introduction

The MPI DTPA Kit – Chelate, a diagnostic radiopharmaceutical agent, is extensively utilized for nuclear medicine imaging, especially for detecting and managing conditions involving the liver, spleen, and other reticuloendothelial system components. As the global nuclear medicine market expands, driven by technological advances and rising disease prevalence, comprehending the clinical development pipeline, market landscape, and future growth trajectories for MPI DTPA Kit – Chelate becomes imperative for stakeholders seeking strategic insights.

---

Clinical Trials Update

Current Development Status

The MPI DTPA Kit – Chelate is predominantly positioned as a diagnostic agent for radiolabeling with technetium-99m (Tc-99m). Its clinical evaluation involves assessing safety, efficacy, and imaging quality across multiple phases. According to ClinicalTrials.gov and other registries, there are no ongoing pivotal clinical trials specifically focused on MPI DTPA Kit – Chelate in recent registries, suggesting that the product has largely transitioned from clinical testing to commercial deployment. Notably, several early-phase studies and pilot investigations have validated its imaging capabilities in detecting splenic and hepatic anomalies.

Regulatory Progress and Approvals

The regulatory pathway for MPI DTPA Kit – Chelate varies geographically. In Europe, the European Medicines Agency (EMA) has approved certain formulations of DTPA-based agents for diagnostic use, notably enabling their widespread adoption in nuclear medicine practices. In the United States, the Food and Drug Administration (FDA) has previously granted approvals for similar chelates, although the specific MPI DTPA formulation awaits formal submission. Market players cite recent stability and safety data as facilitating potential future regulatory filings.

Pipeline Perspectives

While no active registries indicate ongoing Phase III trials explicitly centered on MPI DTPA Kit – Chelate, several research groups explore alternative chelating agents and radiolabeling techniques, implicitly competing with or supplementing the MPI DTPA product line. This evolving competitive landscape underscores the necessity for continuous innovation and strategic regulatory engagement by manufacturers.

---

Market Analysis

Market Overview

The global nuclear medicine market was valued at approximately USD 7 billion in 2022 and is projected to reach USD 11 billion by 2030, registering a compound annual growth rate (CAGR) of around 6% [1]. The surge in demand correlates with the increasing prevalence of cancer, cardiovascular, and infectious diseases, which necessitate advanced diagnostic imaging techniques such as SPECT (Single Photon Emission Computed Tomography).

MPI DTPA Kit – Chelate's primary application lies in diagnostics involving reticuloendothelial system imaging, particularly in hepatic and splenic assessments. Its utilization is favored over older agents due to superior image quality and safety profile.

Competitive Landscape

Key players include manufacturers like Siemens Healthineers, GE Healthcare, and Jubilant Radiopharma, which offer a portfolio of radiopharmaceuticals, including DTPA-based compounds. The market competitiveness of MPI DTPA Kit – Chelate hinges on:

• Regulatory approvals: Facilitating wider distribution
• Manufacturing capacity: Ensuring supply chain resilience
• Technological differentiation: Enhanced imaging clarity and safety
• Cost-effectiveness: Affordable alternatives for developing markets

Regional Market Dynamics

• North America: Dominates due to advanced healthcare infrastructure and high disease burden. The US market is characterized by rapid adoption driven by stringent regulatory standards and innovation.
• Europe: Steady growth owing to regulatory acceptance, with emphasis on expanding nuclear medicine facilities.
• Asia-Pacific: Emerging markets exhibit significant growth potential, fueled by increasing healthcare investments, rising awareness, and higher prevalence of hepatic diseases.

Market Drivers

• Rising incidence of hepatic and splenic diseases
• Technological advancements in SPECT imaging
• Growing geriatric population vulnerable to chronic diseases
• Increasing adoption of minimally invasive diagnostic tools

Challenges and Barriers

• Limited awareness and access in low-resource settings
• Stringent regulatory frameworks impacting time-to-market
• Competition from alternative imaging agents, such as newer radiolabeled chelates
• Supply chain complexities related to radioisotope procurement

---

Market Projection and Future Outlook

Based on current trends, the MPI DTPA Kit – Chelate market is expected to grow at a steady CAGR of approximately 5-6% over the next decade. The growth trajectory hinges on several factors:

• Product Innovation: Development of more stable, high-yielding radiolabeling kits to enhance image resolution and safety.
• Regulatory Advances: Streamlining of approval pathways, especially in emerging markets, to accelerate commercialization.
• Expanding Indications: Potential new applications beyond traditional hepatic and splenic imaging,such as in oncology and infectious disease diagnostics.
• Strategic Collaborations: Partnerships between biotech firms and healthcare providers to expand access and integrate novel imaging protocols.

The emergence of hybrid imaging modalities, like SPECT/CT, will further augment demand for high-quality radiopharmaceuticals like MPI DTPA Kit – Chelate, spurring manufacturers to innovate and differentiate.

---

Key Competitive Strategies

• Investment in Clinical Evidence: Conducting rigorous trials focused on comparative effectiveness and safety to bolster regulatory filings.
• Cost Optimization: Improving manufacturing efficiencies to lower costs and expand access, especially in cost-sensitive markets.
• Regulatory Engagement: Proactively engaging with authorities to expedite approvals and expand indications.
• Technology Enhancement: Developing next-generation chelates with superior stability, half-life, and imaging qualities.

---

Key Takeaways

• The MPI DTPA Kit – Chelate has completed the critical clinical development phases and is positioned for strategic commercialization, though ongoing clinical trials are limited.
• The global nuclear medicine market is expanding, driven by technological innovation, rising disease burden, and favorable healthcare infrastructure.
• Competition within the DTPA and radiopharmaceutical sectors remains intense, necessitating continuous product innovation and regulatory strategy optimization.
• Future growth prospects are promising, especially if manufacturers innovate in stability, safety, and production efficiency, and if regulatory pathways are streamlined.
• Regional market opportunities are particularly notable in Asia-Pacific and emerging economies, offering potential for accelerated market penetration.

---

Frequently Asked Questions (FAQs)

1. What are the primary clinical applications of MPI DTPA Kit – Chelate?
   It primarily facilitates hepatic and splenic imaging in nuclear medicine, aiding in diagnosing conditions like splenomegaly, hepatic tumors, and vascular anomalies.

2. Is MPI DTPA Kit – Chelate approved for use in major markets?
   Regulatory approvals vary; in Europe, DTPA-based agents generally hold approval for diagnostic use, but specific formulations like MPI DTPA Kit may require local registration. In the U.S., formal approval is pending or in process depending on regulatory filings.

3. What factors influence the market growth of MPI DTPA Kit – Chelate?
   Rising disease prevalence, technological advancements in imaging, regulatory approvals, and expanding healthcare infrastructure are key drivers. Challenges include regulatory hurdles and competition from newer agents.

4. What are the competitive advantages of MPI DTPA Kit over alternative radiotracers?
   Advantages include high stability, favorable safety profile, and proven imaging quality. These features can translate to more reliable diagnostics and broader clinical adoption.

5. What future developments could impact the MPI DTPA Kit market?
   Innovations in chelate chemistry, hybrid imaging modalities, and expanded indications, alongside regulatory simplifications, could significantly influence market dynamics.

---

References

[1] Global Nuclear Medicine Market Report, 2022-2030.
[2] ClinicalTrials.gov database entries for DTPA-related studies.
[3] European Medicines Agency (EMA) approvals database.
[4] Industry analysis reports on radiopharmaceuticals and nuclear imaging.