CLINICAL TRIALS PROFILE FOR TECHNETIUM TC-99M MEDRONATE

All Clinical Trials for TECHNETIUM TC-99M MEDRONATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03002454 ↗	Sodium Pertechnetate (99Tc) Injection Generator: 99mTc From Neutron-activation 99Mo v 99mTc From Fission 99Mo	Terminated	Winnipeg Regional Health Authority	Phase 3	2016-08-01	A non-fission sourced, solvent generator produced 99mTc intravenous injection, as 99mTc -MDP, is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone pathology using the same oncologic indications as nuclear reactor sourced 99mTc, as 99mTc-MDP.
NCT03002454 ↗	Sodium Pertechnetate (99Tc) Injection Generator: 99mTc From Neutron-activation 99Mo v 99mTc From Fission 99Mo	Terminated	University of Manitoba	Phase 3	2016-08-01	A non-fission sourced, solvent generator produced 99mTc intravenous injection, as 99mTc -MDP, is to be used as a bone scan diagnostic radiopharmaceutical for assessment of bone pathology using the same oncologic indications as nuclear reactor sourced 99mTc, as 99mTc-MDP.
NCT03707184 ↗	Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men With Prostate Cancer That Has Spread to the Bone	Recruiting	University of Utah	Phase 2	2018-10-02	This trial studies how well fluciclovine 18F PET/CT imaging works in assessing hormone-naive men with prostate cancer that has spread to the bone. Fluciclovine 18F is a radioactive drug used to measure tumor growth. PET/CT uses x-rays to take pictures inside the body. Comparing results of fluciclovine 18F PET/CT imaging may help doctors predict a patient's response to treatment and help plan the best treatment.
NCT05924672 ↗	Efficacy of Ra-223 in PSMA PET Optimally Selected Patients	RECRUITING	Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma	PHASE2	2024-08-30	This phase II trial studies how well prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans (in combination with bone scans) work in selecting patients for Ra-223 radiation therapy that have castration-resistant prostate cancer that has spread from where it first started (primary site) to the bones (bone metastasis). Ra-223 is a type of therapy that emits radiation. Radiation gives off energy which can kill tumor cells and other cells that may support the tumor cells. Ra-223 is given by infusion into the veins, where it is absorbed by the bones. PSMA PET is a type of scan used to detect prostate cancer tumors. PSMA is a radioactive tracer that binds to a specific protein that is found on prostate tumor cells. The PSMA tracer shows the areas on the PET scan where tumor cells are active. A PET scan uses a special camera to detect the energy given off from radioactive tracers (such as PSMA) to make detailed pictures of areas where the tracer accumulates in the body. The PET scan is often combined with a magnetic resonance imaging (MRI) or computed tomography (CT) scan, which helps to map the locations where PSMA has accumulated. PSMA PET scans may be able to select patients that will benefit the most from Ra-223 treatment.
NCT05924672 ↗	Efficacy of Ra-223 in PSMA PET Optimally Selected Patients	RECRUITING	University of California, San Francisco	PHASE2	2024-08-30	This phase II trial studies how well prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans (in combination with bone scans) work in selecting patients for Ra-223 radiation therapy that have castration-resistant prostate cancer that has spread from where it first started (primary site) to the bones (bone metastasis). Ra-223 is a type of therapy that emits radiation. Radiation gives off energy which can kill tumor cells and other cells that may support the tumor cells. Ra-223 is given by infusion into the veins, where it is absorbed by the bones. PSMA PET is a type of scan used to detect prostate cancer tumors. PSMA is a radioactive tracer that binds to a specific protein that is found on prostate tumor cells. The PSMA tracer shows the areas on the PET scan where tumor cells are active. A PET scan uses a special camera to detect the energy given off from radioactive tracers (such as PSMA) to make detailed pictures of areas where the tracer accumulates in the body. The PET scan is often combined with a magnetic resonance imaging (MRI) or computed tomography (CT) scan, which helps to map the locations where PSMA has accumulated. PSMA PET scans may be able to select patients that will benefit the most from Ra-223 treatment.

Clinical Trial Conditions for TECHNETIUM TC-99M MEDRONATE

Condition Name

Condition Name for TECHNETIUM TC-99M MEDRONATE
Intervention	Trials
Cancer of Bone	1
Castration-Resistant Prostate Carcinoma	1
Metastatic Malignant Neoplasm in the Bone	1
Metastatic Prostate Carcinoma	1

Condition MeSH

Condition MeSH for TECHNETIUM TC-99M MEDRONATE
Intervention	Trials
Prostatic Neoplasms	2
Carcinoma	1
Bone Neoplasms	1

Clinical Trial Locations for TECHNETIUM TC-99M MEDRONATE

Trials by Country

Trials by Country for TECHNETIUM TC-99M MEDRONATE
Location	Trials
United States	2
Canada	1

Trials by US State

Trials by US State for TECHNETIUM TC-99M MEDRONATE
Location	Trials
California	1
Utah	1

Clinical Trial Progress for TECHNETIUM TC-99M MEDRONATE

Clinical Trial Phase

Clinical Trial Phase for TECHNETIUM TC-99M MEDRONATE
Clinical Trial Phase	Trials
PHASE2	1
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for TECHNETIUM TC-99M MEDRONATE
Clinical Trial Phase	Trials
Recruiting	2
Terminated	1

Clinical Trial Sponsors for TECHNETIUM TC-99M MEDRONATE

Sponsor Name

Sponsor Name for TECHNETIUM TC-99M MEDRONATE
Sponsor	Trials
Winnipeg Regional Health Authority	1
University of Manitoba	1
University of Utah	1

Sponsor Type

Sponsor Type for TECHNETIUM TC-99M MEDRONATE
Sponsor	Trials
Other	4
INDUSTRY	1

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

Last updated: November 4, 2025

Introduction

Technetium Tc-99m Medronate (commonly known as MDP, or methylene diphosphonate) remains a cornerstone radiopharmaceutical in nuclear medicine, primarily utilized for bone scintigraphy. As a radiotracer, it aids in diagnosing skeletal abnormalities, metastases, and fractures with high sensitivity and specificity. With increasing demand for advanced diagnostic imaging, ongoing clinical developments, and evolving healthcare policies, understanding the current landscape and future outlook of Tc-99m Medronate is vital for industry stakeholders.

Clinical Trials Update

Regulatory and Clinical Development Landscape

Technetium Tc-99m Medronate has a long-established safety and efficacy profile, dating back to its first FDA approval in the 1980s. Ongoing clinical trials are primarily focused on optimizing imaging protocols, expanding indications, and integrating newer imaging technologies.

Most recent clinical studies emphasize:

• Enhanced Imaging Protocols: Trials compare traditional planar scintigraphy with SPECT/CT and PET/CT modalities to improve diagnostic accuracy. These studies, such as those led by institutions in Europe and North America, aim to reduce false negatives/positives, especially in complex metastatic cases [1].

• Novel Indications: Some investigations explore off-label uses, including evaluating degenerative joint diseases and pediatric applications. However, such trials are often in early phases, pending regulatory validation.

• Comparison with Emerging Agents: Current research assesses Tc-99m Medronate's performance relative to newer radiotracers like Fluoride-18 PET agents, especially in detecting skeletal metastases in oncology patients.

Regulatory Advances

While Tc-99m Medronate’s regulatory status remains largely static, there are notable efforts aiming to improve production consistency and ensure compliance with modern manufacturing standards (e.g., GMP). A few regional authorities are reviewing extended indications, reflecting its enduring clinical relevance [2].

Challenges in Clinical Development

• Supply Concerns: Given Tc-99m's reliance on technetium derived from aging nuclear reactors, supply stability remains a concern, impacting clinical trial infrastructure and routine use.

• Technological Integration: Adoption of hybrid imaging modalities continues to influence clinical trial design and outcome measures, necessitating ongoing adaptation.

Market Analysis

Current Market Overview

The global radiopharmaceuticals market, estimated at over USD 5 billion in 2022, shows steady growth driven by increased prevalence of cancer, osteoporosis, and cardiovascular conditions. Technetium-based radiopharmaceuticals account for approximately 65-70% of the diagnostic radiotracer market, with Tc-99m Medronate occupying a significant segment within bone imaging agents.

Major regional markets include:

• North America: Dominates due to advanced healthcare infrastructure, high awareness, and regulatory approvals. The U.S. alone accounts for a substantial portion of Tc-99m Medronate's market share, driven by widespread adoption in hospitals and outpatient imaging centers.

• Europe: Exhibits strong demand, supported by centralized procurement programs and standardized imaging guidelines.

• Asia-Pacific: Fastest-growing region, fueled by expanding healthcare infrastructure, increased cancer screening, and aging populations. Countries like China and India are investing in local production capacities, reducing reliance on imports [3].

Market Drivers

• Rising Incidence of Skeletal Disorders: Osteoporosis affects over 200 million globally, increasing demand for diagnostic imaging. Bone metastases in cancers such as breast, prostate, and lung are detected early via Tc-99m Medronate scans.

• Adoption of Hybrid Imaging: SPECT/CT integration enhances diagnostic precision, prompting increased use of Tc-99m compounds.

• Regulatory Support and Reimbursement Policies: Positive reimbursement ideologies in key markets facilitate widespread use.

Market Challenges

• Supply Chain Disruptions: The limited number of molybdenum-99 (Mo-99) producing reactors affects Tc-99m availability, leading to potential shortages.

• Emergence of Alternative Imaging Agents: Development of PET tracers, such as F-18-fluoride, offers higher resolution imaging, posing competitive threats.

• Environmental and Regulatory Pressures: stricter policies on nuclear medicine waste management may impact operational costs.

Competitive Landscape

Major manufacturers include:

• GE Healthcare: Provides proprietary radiopharmaceuticals and related imaging systems.

• Bracco Imaging: Offers Technetium-based radiotracers with widespread distribution networks.

• Westcott Technologies and Jubilant Radiopharma: Focus on regional markets and local production.

Market consolidation and licensing agreements continue to shape the competitive environment, ensuring supply stability and innovation.

Market Projection

The global bone scan radiotracer market is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% from 2023 to 2030. Key factors influencing this trajectory include:

• Accelerated Adoption of Hybrid Imaging: The integration of SPECT/CT and PET/CT enhances diagnostic accuracy. As these technologies become standard, the utilization of Tc-99m Medronate is expected to rise correspondingly.

• Aging Populations: The global demographic shift toward older age brackets will increase demand for osteoporosis and metastatic cancer diagnostics.

• Regulatory Enhancements and Reimbursement: Regions with supportive policies will drive further use, especially in emerging markets.

• Supply Chain Optimization: Innovations in reactor technology and alternative Mo-99 production methods are expected to mitigate shortages, stabilizing supply.

• Competitive Displacement: While PET agents pose competition, their higher costs and limited availability currently restrain their dominance, favoring continued reliance on Tc-99m radiopharmaceuticals.

Overall, the market for Tc-99m Medronate is expected to maintain its dominance in skeletal imaging, with incremental shifts towards hybrid imaging and integrated diagnostic strategies.

Key Opportunities and Risks

Opportunities

• Expanding Indications: Exploring new clinical applications, such as in inflammatory or infectious bone diseases, could unlock additional market segments.

• Regional Expansion: Increasing adoption in Asia-Pacific and Latin America through collaborations and local production.

• Technological Integration: Developing and promoting hybrid imaging protocols to improve diagnostic confidence.

Risks

• Supply Disruptions: Dependency on aging Mo-99 reactors remains a vulnerability. Ongoing efforts to develop alternative sources, like accelerator-produced Tc-99m, are crucial.

• Regulatory Barriers: Variances in approval processes may delay product launches and expansion.

• Technological Competition: Advances in PET imaging and other modalities threaten to displace Tc-99m-based diagnostics.

Conclusion

Technetium Tc-99m Medronate sustains a robust clinical and commercial profile driven by its longstanding efficacy, integration into hybrid imaging, and high clinical demand for skeletal diagnostics. While supply chain vulnerabilities and emerging competition pose challenges, ongoing clinical innovations and regional market growth present considerable opportunities.

Stakeholders should focus on enhancing production stability, exploring expanded indications, and integrating technological advances to sustain competitive advantage and capitalize on the growing global diagnostic imaging market.

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Key Takeaways

• The clinical development focus for Tc-99m Medronate emphasizes protocol optimization and expansion into new indications, ensuring it remains relevant in the evolving nuclear medicine landscape.

• Market growth is underpinned by increasing skeletal health issues, hybrid imaging adoption, and demographic shifts, projecting steady expansion through 2030.

• Supply chain stability remains a critical challenge; innovations in reactor technology and alternative production are essential to meet demand.

• Geographies like Asia-Pacific offer significant growth potential due to expanding healthcare infrastructure and rising disease prevalence.

• Emerging imaging modalities pose a competitive threat but currently complement rather than replace Tc-99m Medronate in diagnostic workflows.

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FAQs

1. What are the main clinical applications of Technetium Tc-99m Medronate?
   Its primary use is in bone scintigraphy to detect abnormalities such as metastases, fractures, infections, and degenerative diseases, leveraging its affinity for bone mineral.

2. How does hybrid imaging impact the use of Tc-99m Medronate?
   Combining SPECT with CT improves lesion localization and diagnostic accuracy, expanding its clinical utility and driving increased adoption.

3. What are the supply challenges associated with Tc-99m Medronate?
   It depends on Mo-99, produced in aging nuclear reactors, leading to potential shortages. Alternative production methods like accelerator-based technetium are under development.

4. Are there ongoing clinical trials for new indications of Tc-99m Medronate?
   Yes. Trials are investigating its application in inflammatory and infectious bone conditions, though these are still emerging.

5. How does the competition from PET tracers influence the Tc-99m Medronate market?
   PET tracers like F-18-fluoride offer higher resolution but are costlier and less available, maintaining Tc-99m Medronate’s role as the preferred, cost-effective option for broad skeletal imaging.

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References

[1] European Society of Radiology. "Advances in Bone Imaging: SPECT/CT and Beyond." ESR Journal, 2021.

[2] U.S. Food and Drug Administration. "Radiopharmaceuticals: Regulatory Updates." FDA, 2022.

[3] MarketWatch. "Nuclear Medicine Radiopharmaceuticals Market Size and Forecast." 2023.