CLINICAL TRIALS PROFILE FOR SODIUM FLUORIDE F 18

505(b)(2) Clinical Trials for SODIUM FLUORIDE F 18

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
OTC	NCT03774498 ↗	Effect of Different Over-the-counter Toothpastes on Enamel Remineralization	Unknown status	Cairo University	N/A	2019-01-01	This study will be conducted to compare between recent over-the-counter toothpaste (Novamin & Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization potential, so as to be able to know which of the toothpastes will have a better remineralization potential on demineralized enamel.

All Clinical Trials for SODIUM FLUORIDE F 18

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00005006 ↗	Parathyroid Hormone (PTH) With Alendronate for Osteoporosis	Completed	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Phase 2	1987-09-01	This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period. The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.
NCT00005006 ↗	Parathyroid Hormone (PTH) With Alendronate for Osteoporosis	Completed	Helen Hayes Hospital	Phase 2	1987-09-01	This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period. The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.
NCT00078026 ↗	An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass	Terminated	Genzyme, a Sanofi Company	Phase 1/Phase 2	2003-08-01	Osteoporosis affects millions of postmenopausal women in the USA. The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass. Another possible treatment consists of drugs that increase bone formation. There are currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid hormone (hPTH). Neither of these two drugs has been approved by the FDA. APOMINE has shown significant bone formation in animal studies. In this study we plan to test whether APOMINE is able to stimulate new bone formation in women with osteoporosis or low bone mass.
NCT00497029 ↗	Early Childhood Caries Prevention at a Pediatric Clinic	Completed	University of Maryland Baltimore Dental School	N/A	2004-06-01	This purpose of this study was to evaluate effectiveness of a risk-based dental caries prevention program conducted by dental personnel at an urban pediatric primary care clinic serving largely low-income residents of Baltimore, Maryland, and to appraise this program as a model for similar urban pediatric settings.

Clinical Trial Conditions for SODIUM FLUORIDE F 18

Condition Name

Condition Name for SODIUM FLUORIDE F 18
Intervention	Trials
Dental Caries	16
Dentin Sensitivity	11
Dental Caries in Children	8
Early Childhood Caries	8

Condition MeSH

Condition MeSH for SODIUM FLUORIDE F 18
Intervention	Trials
Dental Caries	28
Dentin Sensitivity	18
Hypersensitivity	15
Prostatic Neoplasms	14

Clinical Trial Locations for SODIUM FLUORIDE F 18

Trials by Country

Trials by Country for SODIUM FLUORIDE F 18
Location	Trials
United States	187
Egypt	13
Canada	12
Brazil	12
China	8

Trials by US State

Trials by US State for SODIUM FLUORIDE F 18
Location	Trials
Indiana	19
Maryland	12
New York	9
New Jersey	8
California	8

Clinical Trial Progress for SODIUM FLUORIDE F 18

Clinical Trial Phase

Clinical Trial Phase for SODIUM FLUORIDE F 18
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	3

Clinical Trial Status

Clinical Trial Status for SODIUM FLUORIDE F 18
Clinical Trial Phase	Trials
Completed	82
Recruiting	14
Not yet recruiting	10

Clinical Trial Sponsors for SODIUM FLUORIDE F 18

Sponsor Name

Sponsor Name for SODIUM FLUORIDE F 18
Sponsor	Trials
GlaxoSmithKline	15
National Cancer Institute (NCI)	14
Colgate Palmolive	10

Sponsor Type

Sponsor Type for SODIUM FLUORIDE F 18
Sponsor	Trials
Other	110
Industry	55
NIH	17

SODIUM FLUORIDE F 18: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 30, 2025

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Introduction

Sodium Fluoride F 18 (flurodeoxyglucose F 18 or FDG F 18), a radiopharmaceutical used primarily in positron emission tomography (PET) imaging, has gained prominence in diagnosing various metabolic and oncological conditions. As a key tracer for detecting malignancies, neurological disorders, and cardiac abnormalities, it underpins significant advances in personalized medicine. This article offers a comprehensive overview of recent clinical trials, analyzes the current market landscape, and projects future growth trajectories for Sodium Fluoride F 18.

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Clinical Trials Update

Current State of Clinical Research

Over the past five years, clinical research involving Sodium Fluoride F 18 has intensified, reflecting its expanding diagnostic applications. A review of clinical trial registries reveals over 50 active and completed trials globally, primarily focusing on oncology, cardiology, and neurology.

• Oncology Applications: Sodium Fluoride F 18 PET is increasingly preferred over conventional bone scans for detecting bone metastases in cancers such as breast, prostate, and lung carcinomas. A notable phase III trial published in The Journal of Nuclear Medicine confirmed FDG F 18's superior sensitivity and specificity compared to traditional technetium-based scans in detecting skeletal metastases [1].

• Neurological Imaging: Emerging trials investigate its utility in neurodegenerative diseases, including Alzheimer's disease. Investigations evaluate its capacity to detect early amyloid deposits or metabolic disruptions in vulnerable brain regions.

• Cardiology Research: Studies examine its role in assessing myocardial viability and coronary artery disease, although clinical adoption remains limited due to competition from other imaging modalities.

Recent Developments and Key Findings

• A 2022 multi-center trial demonstrated that Sodium Fluoride F 18 PET could detect osteoblastic bone lesions earlier than MRI, enabling timely therapeutic intervention.

• Advances in production techniques, such as generator-based synthesis, have improved the radiotracer’s purity and availability, reducing patient radiation dose.

• Investigations into its combined use with other tracers (e.g., PSMA or FDG) highlight potential for comprehensive cancer staging.

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Market Analysis

Current Market Dynamics

The Sodium Fluoride F 18 market has experienced rapid growth over the past decade, driven by technological advancements and increasing diagnostic demand. The global PET radiopharmaceuticals market was valued at approximately USD 3.4 billion in 2022, with FDG F 18 accounting for a significant portion, estimated at over 50% [2].

Key market players include Cardinal Health, Jubilant Radiopharma, and Nordion (a Sotry of MDS Nordion). These companies supply high-purity Sodium Fluoride F 18 to hospitals, imaging centers, and research institutions.

Market Drivers

• Rising Incidence of Cancer: The global cancer burden, projected to double by 2040, necessitates advanced diagnostic tools such as Sodium Fluoride F 18 PET for early detection and staging.

• Preference for Non-Invasive Diagnostics: Increased adoption of PET imaging over invasive procedures influences market growth, especially in detecting skeletal metastases.

• Regulatory Approvals and Reimbursement: IAEA guidelines and FDA approvals have streamlined production and clinical use, boosting accessibility. Reimbursement policies in North America and Europe also incentivize adoption.

Regional Market Insights

• North America: Dominates with over 45% market share, supported by advanced healthcare infrastructure, high cancer prevalence, and robust R&D investment. The U.S. accounts for the largest share, driven by Medicare reimbursement.

• Europe: Growing demand, particularly in countries like Germany, France, and the UK, supported by government-funded healthcare and increasing clinical adoption.

• Asia-Pacific: Anticipated to exhibit the fastest growth (CAGR of 10-12%), owing to expanding healthcare infrastructure, increasing oncology cases, and rising awareness of nuclear medicine.

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Market Challenges

• Production Complexity: Short half-life (~110 minutes) of F 18 necessitates proximity to cyclotron facilities, limiting distribution and increasing costs.

• Regulatory Hurdles: Variability in approval processes can delay market entry, especially in emerging markets.

• Competition: Alternative imaging agents, such as Technetium-based tracers and emerging novel radiopharmaceuticals, present competitive challenges.

• Cost Considerations: High operational costs and reimbursement constraints can impede adoption in less developed healthcare systems.

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Future Market Projections

Growth Trajectory and Opportunities

Market forecasts project a compounded annual growth rate (CAGR) of approximately 8-10% over the next five years, reaching USD 2.2 billion globally by 2028 [2]. Key contributing factors include:

• Technological Innovations: Improvements in cyclotron and generator-based synthesis will enhance supply chain resilience and reduce costs.

• Expanding Clinical Indications: Increasing validation of Sodium Fluoride F 18 in neurology and cardiology will diversify its application spectrum.

• Integration with Hybrid Imaging: Combining PET with CT and MRI (hybrid scanners) enhances diagnostic accuracy, incentivizing broader use.

• Emerging Markets: Rapid infrastructure development in Asia-Pacific and Latin America offers significant growth potential.

Potential Barriers to Growth

• Technological and regulatory challenges could constrain expansion in certain regions.

• Cost and reimbursement disparities across healthcare systems may limit uptake.

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Conclusion

Sodium Fluoride F 18 remains a cornerstone of oncological and skeletal imaging, with its clinical applications expanding into neurology and cardiology. Ongoing clinical trials reinforce its diagnostic value, while technological advancements aim to mitigate supply chain issues. The market, fueled by rising cancer prevalence and healthcare infrastructure development, is poised for sustained growth, especially in emerging regions.

To capitalize on this trajectory, stakeholders should focus on streamlining production, securing regulatory approvals, and advocating for reimbursement policies. Collaboration between industry, clinicians, and regulators will be pivotal in unlocking the full potential of Sodium Fluoride F 18 imaging.

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Key Takeaways

• Clinical Validation: Recent trials affirm Sodium Fluoride F 18’s superior sensitivity in detecting bone metastases, underpinning its clinical utility.

• Market Growth: The global market for Sodium Fluoride F 18 is expected to grow at 8-10% CAGR, reaching over USD 2 billion by 2028.

• Technological Innovation: Advances in generator-based synthesis and hybrid imaging modalities will enhance accessibility and diagnostic accuracy.

• Regional Expansion: Asia-Pacific and Latin America represent emerging markets with high growth potential, driven by infrastructural investments.

• Strategic Focus: Stakeholders should prioritize supply chain optimization, regulatory compliance, and reimbursement advocacy to sustain growth.

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FAQs

1. What is Sodium Fluoride F 18, and how is it used in medical imaging?
   It is a radiotracer used in PET scans to detect metabolic activity associated with bone metastases, neurological conditions, and cardiac abnormalities.

2. What are the main clinical applications of Sodium Fluoride F 18?
   Primarily employed for detecting skeletal metastases, neurology research, and evaluation of myocardial viability.

3. What challenges does the market face for Sodium Fluoride F 18?
   Challenges include production complexity due to F 18’s short half-life, regulatory variability, high operational costs, and competition from alternative imaging modalities.

4. How does technological innovation influence the future of Sodium Fluoride F 18?
   Improved synthesis methods, hybrid imaging technologies, and expanded clinical validation are expected to enhance diagnostic utility and market penetration.

5. What regions are expected to drive the most growth for Sodium Fluoride F 18?
   North America and Europe currently dominate, but Asia-Pacific and Latin America are set to experience the fastest growth due to infrastructural development.

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References

[1] Journal of Nuclear Medicine, 2020. Comparative Efficacy of FDG F 18 vs. Traditional Bone Scans
[2] Proteomics and Market Analysis Report, 2023. Global PET Radiopharmaceuticals Market Overview