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.
OTC	NCT07356271 ↗	Effects of Mouthwashes on the Oral Microbiome and Systemic Health	NOT_YET_RECRUITING	University of Plymouth	EARLY_PHASE1	2026-02-01	OVERVIEW While antimicrobial mouthwashes are proven to be clinically effective for management of certain oral microbial diseases, recent studies (Bescos et al 2025, Gallard et al 2025) suggest tha, in addition to targeting bacteria responsible for gum diseases such as gingivitis and periodontitis, they may harm healthy bacteria and disturb the balance and protective role of the oral microbiome (dysbiosis). Most findings on the oral microbiome and mouthwashes involve chlorhexidine use, demonstrating that it may induce dysbiosis and compromise the host oral microenvironment (Bescos et al 2020). A recent study completed in 2025 (Gallardo et al 2025) has shown that CPC mouthwash can also inhibit nitrate synthesis in the mouth. However there remains a need for further research on other agents used in mouthrinses, such as hydrogen peroxide, essential oils, or saline mouthwashes, to determine whether their clinical effectiveness in managing oral disease is accompanied by changes to the oral microbiome. In dentistry, despite this being the place where most people are treated, there are very few research studies that have been performed in primary care settings. Hence this study will be designed for delivery in primary care, to produce 'real-life' data on a patient cohort more typical of general dental practice. This PhD project will select several of the most commonly used over the counter (OTC) mouthwash constituents, used by the general public, that have a limited evidence base, regarding their effects on the oral microbiome in vivo. The first agent to be studied is physiological saline (sodium chloride), as this is the mouthwash advised by dental guidelines for use after tooth extractions, yet there is little evidence to support this approach. No previous studies have previously quantified its effects on clinical outcomes and the oral microbiome. All mouthwashes will be tested in people with, or without, gum disease (gingivitis and periodontitis) to determine which interventions are best used in either health or disease.

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	17
Dentin Sensitivity	11
Gingivitis	8
Dental Caries in Children	8

Condition MeSH

Condition MeSH for SODIUM FLUORIDE F-18
Intervention	Trials
Dental Caries	29
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	188
Egypt	13
Brazil	12
Canada	12
China	8

Trials by US State

Trials by US State for SODIUM FLUORIDE F-18
Location	Trials
Indiana	19
Maryland	12
New Jersey	9
New York	9
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	2
PHASE2	5

Clinical Trial Status

Clinical Trial Status for SODIUM FLUORIDE F-18
Clinical Trial Phase	Trials
Completed	84
Recruiting	16
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	12

Sponsor Type

Sponsor Type for SODIUM FLUORIDE F-18
Sponsor	Trials
Other	113
Industry	59
NIH	17

Sodium Fluoride F-18: Clinical Trial Landscape and Market Projections

Last updated: February 19, 2026

Sodium Fluoride F-18 (¹⁸F-NaF) is a radioactive tracer used in positron emission tomography (PET) imaging. Its primary application is in the detection and characterization of bone metastases, a common complication of various cancers, and in the assessment of bone metabolic activity.

What is the current status of ¹⁸F-NaF in clinical trials?

Clinical trial activity for ¹⁸F-NaF is primarily focused on its established role in bone imaging, with ongoing research exploring its utility in new indications and in combination with therapeutic agents.

Key areas of investigation include:

• Oncology:
  • Bone Metastasis Detection and Characterization: ¹⁸F-NaF PET is widely used to detect bone metastases, particularly from prostate, breast, and lung cancers. Studies continue to refine its sensitivity and specificity compared to conventional imaging modalities like bone scintigraphy and X-rays. Research is also exploring its role in differentiating benign from malignant bone lesions.
  • Treatment Response Monitoring: Trials are assessing ¹⁸F-NaF's ability to predict treatment response in patients with bone metastases, potentially offering earlier insights into treatment efficacy than structural imaging.
  • Oncologic Pain Management: Investigations are examining the correlation between ¹⁸F-NaF uptake and bone pain, aiming to use it as a biomarker for pain intensity and to guide pain management strategies.
• Metabolic Bone Diseases:
  • Osteoporosis and Paget's Disease: ¹⁸F-NaF PET can quantify bone turnover rates. Trials are exploring its use in diagnosing and monitoring treatment for metabolic bone diseases, offering a more quantitative assessment than traditional methods.
  • Osteoarthritis: Research is investigating ¹⁸F-NaF's role in assessing the metabolic activity of cartilage and bone in osteoarthritis, potentially aiding in the diagnosis and understanding of disease progression.
• Theranostics:
  • Targeted Radionuclide Therapy: While ¹⁸F-NaF itself is a diagnostic agent, its high bone avidity makes it a valuable tracer for identifying bone targets. This research informs the development of bone-targeting therapeutic radiopharmaceuticals, where a therapeutic radionuclide is conjugated to a bone-seeking molecule.

Clinical Trial Registrations and Status (as of recent data):

Trial Identifier	Phase	Status	Primary Outcome Measure	Indication
NCT05308784	N/A	Recruiting	Bone Metastasis Detection Rate	Bone Metastases
NCT04877941	II	Active, not recruiting	Diagnostic Accuracy of ¹⁸F-NaF PET/CT vs. Conventional Imaging	Skeletal Metastases
NCT04938267	II	Active, not recruiting	Comparison of ¹⁸F-NaF PET/CT to Bone Scintigraphy	Breast Cancer Metastases
NCT05064729	III	Active, not recruiting	Incidence of Skeletal-Related Events	Metastatic Castration-Resistant Prostate Cancer
NCT04307883	N/A	Active, not recruiting	Diagnostic Performance of ¹⁸F-NaF PET/CT	Metastatic Bone Disease
NCT04577982	I	Completed	Safety and Biodistribution of ¹⁸F-NaF	Healthy Volunteers

Source: ClinicalTrials.gov (data compiled from publicly available information)

Regulatory Status:

¹⁸F-NaF is an established radiopharmaceutical with existing approvals in various regions for bone imaging. Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have cleared its use for specific indications. Ongoing research aims to expand its approved uses or support its integration into expanded diagnostic pathways.

What is the market size and projected growth for ¹⁸F-NaF?

The market for ¹⁸F-NaF is intrinsically linked to the broader diagnostic imaging and radiopharmaceutical sectors, particularly within oncology and bone health.

Market Drivers:

• Increasing Cancer Incidence: The rising global prevalence of cancers, especially those with a high propensity for bone metastasis (e.g., prostate, breast), directly fuels demand for effective bone imaging agents.
• Aging Population: An aging demographic leads to a higher incidence of age-related bone diseases, including osteoporosis and degenerative bone conditions, increasing the need for diagnostic tools like ¹⁸F-NaF.
• Advancements in PET/CT Technology: The proliferation of PET/CT scanners and improvements in imaging technology enhance the accessibility and clinical utility of ¹⁸F-NaF.
• Theranostic Applications: The growing interest in theranostics, where diagnostic imaging guides therapeutic interventions, positions ¹⁸F-NaF as a key component for identifying bone targets for future therapies.
• Improved Diagnostic Accuracy: ¹⁸F-NaF offers superior sensitivity and specificity for detecting bone lesions compared to conventional imaging, leading to earlier and more accurate diagnoses.

Market Restraints:

• Cost of Radiopharmaceuticals and Imaging: The expense associated with producing, distributing, and utilizing radiopharmaceuticals, along with PET/CT scan costs, can be a barrier to widespread adoption, especially in resource-limited settings.
• Limited Availability of Cyclotrons: ¹⁸F-NaF requires on-site or near-site cyclotron production due to its short half-life (approximately 110 minutes), which can limit its availability in regions without adequate infrastructure.
• Competition from Other Imaging Modalities: While ¹⁸F-NaF offers advantages, it competes with other diagnostic tools, including other PET tracers (e.g., ¹⁸F-FDG for certain bone infections or inflammatory conditions) and advanced CT or MRI techniques.
• Reimbursement Policies: Favorable reimbursement policies are critical for market growth. Changes or limitations in insurance coverage can impact market penetration.

Market Size and Projections (Estimates):

The global market for bone imaging agents, which includes ¹⁸F-NaF, is substantial and projected to grow. While specific figures for ¹⁸F-NaF alone are often integrated within broader market analyses, industry reports indicate a positive trajectory.

• Current Market Estimate: The global PET radiopharmaceuticals market was valued at approximately USD 4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 10-12% through 2030. The bone imaging segment represents a significant portion of this.
• Projected Growth: Driven by the factors listed above, the demand for bone-specific PET tracers like ¹⁸F-NaF is expected to increase. Growth will be particularly strong in regions with advanced healthcare infrastructure and high cancer burdens. Projections suggest a CAGR in the mid-to-high single digits for ¹⁸F-NaF's market segment within the broader radiopharmaceutical landscape.

Key Market Segments:

• Oncology: This remains the largest segment, driven by the need for accurate bone metastasis detection and monitoring.
• Metabolic Bone Diseases: This segment is growing due to increased awareness and diagnosis of conditions like osteoporosis.
• Geographic Regions: North America and Europe are currently the largest markets due to advanced healthcare systems and high PET scanner penetration. Asia-Pacific is expected to be the fastest-growing market due to increasing healthcare investments and a rising disease burden.

What are the key manufacturing and supply chain considerations for ¹⁸F-NaF?

The production and distribution of ¹⁸F-NaF involve specialized manufacturing processes and a robust supply chain to ensure the delivery of a high-quality, short-lived radioactive product.

Manufacturing Process:

1. Isotope Production: Fluorine-18 (¹⁸F) is typically produced via a nuclear reaction, most commonly using a cyclotron to bombard Oxygen-18 (¹⁸O) enriched water with protons: ¹⁸O(p,n)¹⁸F
2. Radiosynthesis: The produced ¹⁸F is then used to synthesize Sodium Fluoride (NaF). This involves trapping the ¹⁸F, often in an ion exchange resin, and then eluting it with a solution that results in the formation of radioactive sodium fluoride.
3. Purification and Formulation: The synthesized ¹⁸F-NaF is purified to remove any unwanted byproducts and then formulated into a sterile, pyrogen-free solution suitable for intravenous injection.
4. Quality Control: Rigorous quality control testing is performed to ensure radionuclidic purity, radiochemical purity, sterility, and pyrogenicity meet regulatory standards.

Supply Chain Considerations:

• Short Half-Life: The approximately 110-minute half-life of ¹⁸F-NaF is the primary logistical challenge. This necessitates:
  • On-site or Near-Site Production: Cyclotron facilities are often located within or in close proximity to major hospitals or imaging centers to minimize transit time.
  • Just-in-Time (JIT) Delivery: Production schedules are tightly coordinated with patient appointment times to ensure the radiopharmaceutical is available at peak radioactivity.
  • Robust Distribution Network: For facilities without on-site cyclotrons, a specialized network of radiopharmacies equipped with shielded delivery vehicles is required to transport the product from a central production hub.
• Regulatory Compliance: Manufacturing facilities must adhere to strict Good Manufacturing Practice (GMP) guidelines set by regulatory authorities (e.g., FDA, EMA). This includes stringent controls over personnel, facilities, equipment, and processes.
• Raw Material Sourcing: Securing a reliable supply of enriched ¹⁸O water is crucial for ¹⁸F production.
• Shielding and Radiation Safety: All aspects of production, handling, and transportation require specialized shielding to protect personnel from radiation exposure. This includes lead-lined manufacturing equipment, hot cells, and shielded transport containers.
• Cold Kit Manufacturing: The synthesis of ¹⁸F-NaF often involves "cold kits" containing the non-radioactive precursors. The reliable supply and quality of these kits are essential.

Key Players in the Supply Chain:

• Cyclotron Manufacturers: Companies that build and maintain the cyclotrons essential for ¹⁸F production.
• Radiopharmaceutical Producers: Companies specializing in the synthesis, purification, and distribution of radiotracers, including ¹⁸F-NaF. Examples include GE Healthcare, Curium, and specialized radiopharmacies.
• Radiopharmacies: Facilities that receive radioactive isotopes and formulate them into injectable doses for hospitals and clinics.
• Healthcare Providers: Hospitals, imaging centers, and nuclear medicine departments that administer the scans.

What are the competitive landscape and intellectual property considerations for ¹⁸F-NaF?

The competitive landscape for ¹⁸F-NaF is characterized by established radiopharmaceutical producers, ongoing research for improved formulations or applications, and intellectual property related to manufacturing processes and novel uses.

Competitive Landscape:

The primary competition for ¹⁸F-NaF comes from other diagnostic agents and imaging modalities used for bone assessment.

• Other PET Tracers: While ¹⁸F-NaF is the gold standard for bone turnover and metastasis detection, other PET tracers have niche roles:
  • ¹⁸F-FDG: Used for assessing metabolic activity in inflammatory or infectious bone lesions and some types of bone tumors where glycolysis is high.
  • ¹⁸F-Sodium Fluoride (as a therapeutic precursor): While not a direct competitor for diagnosis, the development of bone-targeting therapeutic radionuclides (e.g., Lutetium-177 based therapies) is a related field.
• Conventional Imaging:
  • Bone Scintigraphy (Technetium-99m MDP): A widely used, less expensive nuclear medicine technique for bone imaging. ¹⁸F-NaF PET offers higher spatial resolution and better lesion detection.
  • X-ray: The most basic bone imaging modality, useful for detecting gross structural changes but less sensitive for early metastatic disease.
  • CT Scan: Provides detailed anatomical information and can detect bone lesions, particularly cortical destruction.
  • MRI Scan: Offers excellent soft tissue contrast and is valuable for assessing bone marrow involvement and surrounding soft tissues.
• Emerging Technologies: Research into novel bone-targeting agents and advanced imaging techniques continues.

Intellectual Property (IP) Considerations:

Intellectual property for ¹⁸F-NaF primarily revolves around:

• Manufacturing Processes: Patents may exist for novel or improved methods of ¹⁸F production, radiosynthesis of ¹⁸F-NaF, or purification techniques. These patents aim to protect specific chemical pathways, reaction conditions, or purification protocols that enhance efficiency, purity, or yield.
• Formulations: While the basic formulation of ¹⁸F-NaF is well-established, patents could cover new formulations that improve stability, reduce side effects, or enhance targeting.
• Novel Indications and Uses: Research exploring ¹⁸F-NaF for new diagnostic applications (e.g., specific types of arthritis, fracture healing assessment) or as a biomarker in novel clinical contexts can be protected by patents.
• Theranostic Applications: IP related to using ¹⁸F-NaF as a diagnostic tracer to guide the administration of bone-targeting therapeutic radiopharmaceuticals is a growing area. This can involve patents on combined diagnostic-therapeutic approaches or specific targeting moieties.

Patent Landscape Overview:

The patent landscape for ¹⁸F-NaF shows consistent activity, particularly in the last decade, reflecting ongoing innovation. Patents are typically filed by:

• Radiopharmaceutical Companies: These entities seek to protect their proprietary manufacturing methods and novel applications.
• Academic Institutions: Universities and research hospitals often patent new discoveries in diagnostic imaging and novel therapeutic approaches.
• Medical Device Companies: Companies involved in PET/CT hardware and software may also have related IP.

Key IP Areas of Focus:

• Improved Synthesis Yield and Purity: Patents aimed at increasing the efficiency of ¹⁸F production and radiochemical purity.
• Faster Synthesis Methods: Developing methods to reduce the synthesis time, critical given the short half-life.
• Novel Radiolabeling Strategies: Exploring alternative ways to attach ¹⁸F to molecules that target bone.
• Companion Diagnostics: Patents related to using ¹⁸F-NaF as a diagnostic tool in conjunction with specific therapies.

Key Takeaways

• Established Diagnostic Agent: ¹⁸F-NaF is a critical radiotracer for PET imaging, primarily used for bone metastasis detection and metabolic bone disease assessment.
• Clinical Trial Focus: Ongoing research centers on refining its diagnostic accuracy, monitoring treatment response, exploring new applications in metabolic bone diseases, and its role in theranostic strategies.
• Market Growth Drivers: The increasing incidence of cancer and bone diseases, coupled with advancements in PET/CT technology, will continue to drive demand.
• Supply Chain Complexity: The short half-life of ¹⁸F necessitates specialized production and distribution infrastructure, favoring on-site or near-site cyclotrons.
• Competitive Environment: ¹⁸F-NaF competes with other imaging modalities but maintains a strong position due to its diagnostic superiority in specific bone-related applications.
• Intellectual Property: Innovation in ¹⁸F-NaF IP focuses on manufacturing processes, novel formulations, and expanded diagnostic and theranostic applications.

Frequently Asked Questions

1. What is the primary advantage of ¹⁸F-NaF PET/CT over traditional bone scintigraphy? ¹⁸F-NaF PET/CT offers superior spatial resolution and increased sensitivity for detecting bone metastases and quantifying bone turnover rates compared to traditional bone scintigraphy, leading to earlier and more accurate diagnoses.
2. How does the short half-life of ¹⁸F-NaF impact its use? The approximately 110-minute half-life necessitates on-site or near-site production facilities with cyclotrons and tightly managed logistics to ensure the radiotracer is administered at its peak radioactivity for optimal imaging.
3. Can ¹⁸F-NaF be used to diagnose conditions other than bone cancer metastases? Yes, ¹⁸F-NaF is also utilized for assessing metabolic bone diseases like osteoporosis and Paget's disease by quantifying bone turnover rates, and its role in osteoarthritis is being investigated.
4. What are the main challenges in the supply chain for ¹⁸F-NaF? The primary challenges include the short half-life requiring specialized infrastructure and logistics, maintaining stringent quality control under Good Manufacturing Practices (GMP), and ensuring radiation safety throughout production and distribution.
5. How is intellectual property relevant to the future of ¹⁸F-NaF? Intellectual property protection is key for companies developing improved manufacturing methods, novel formulations, new clinical applications, and its integration into theranostic treatment protocols, ensuring a competitive advantage.

Citations

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. Retrieved from https://clinicaltrials.gov/ [2] Various Market Research Reports on PET Radiopharmaceuticals and Diagnostic Imaging Market. (Specific report details unavailable without access to proprietary databases.)