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.

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
Early Childhood Caries	8

Condition MeSH

Condition MeSH for SODIUM FLUORIDE F 18
Intervention	Trials
Dental Caries	29
Dentin Sensitivity	18
Hypersensitivity	15

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 radiopharmaceutical primarily used in bone scintigraphy for the detection and management of bone metastases and metabolic bone diseases. Its diagnostic utility is driven by its high affinity for bone mineral and its ability to detect early changes in bone turnover. This analysis outlines the current clinical trial landscape for ¹⁸F-NaF, assesses its market position, and projects future market trends.

What is the Current Clinical Trial Status of Sodium Fluoride F 18?

The clinical trial landscape for ¹⁸F-NaF is characterized by ongoing investigational studies focused on refining its diagnostic applications and exploring new therapeutic adjunctive roles. While ¹⁸F-NaF is an established diagnostic agent, research continues to delineate its precise role in various oncological and rheumatological settings.

Key Investigational Areas

• Oncology:
  • Prostate Cancer: ¹⁸F-NaF PET/CT is evaluated for detecting bone metastases, particularly in cases of biochemical recurrence where conventional imaging is negative [1]. Trials are assessing its sensitivity and specificity compared to bone scintigraphy and other PET tracers like prostate-specific membrane antigen (PSMA) PET [2].
  • Breast Cancer: Its utility in identifying bone metastases, especially in early-stage disease or for assessing treatment response, is under investigation [3]. Comparative studies with ¹⁸F-FDG and bone scintigraphy are common.
  • Other Cancers: Studies are ongoing for its role in detecting bone involvement in lung cancer, multiple myeloma, and other solid tumors [4].
• Metabolic Bone Diseases:
  • Osteoporosis: Research continues to explore ¹⁸F-NaF PET/CT as a quantitative measure of bone turnover in osteoporosis, potentially aiding in risk stratification and treatment monitoring [5].
  • Paget's Disease: Its diagnostic and monitoring capabilities in Paget's disease, a chronic disorder characterized by enlarged and misshapen bones, remain an area of interest [6].
• Inflammatory and Infectious Conditions:
  • Emerging research investigates ¹⁸F-NaF's potential in identifying osteomyelitis and other bone infections due to its uptake in areas of increased osteoblastic activity [7].

Notable Clinical Trial Registries and Numbers

As of the latest available data, the number of registered clinical trials involving ¹⁸F-NaF varies across different registries.

• ClinicalTrials.gov: A search reveals approximately 150-200 active and completed trials that list Sodium Fluoride F 18 as an intervention or key element. These trials span various phases, from Phase I (safety and dosing) to Phase IV (post-market studies) [8].
• EU Clinical Trials Register: This register contains a smaller but significant number of trials, focusing on European research initiatives.
• Australian New Zealand Clinical Trials Registry (ANZCTR): Trials in this region also contribute to the global research pool.

The distribution of these trials indicates a sustained interest in ¹⁸F-NaF, with a significant proportion focused on oncological applications. For instance, studies specifically investigating ¹⁸F-NaF for prostate cancer bone metastases constitute roughly 30-40% of the total ongoing research.

What is the Current Market Landscape for Sodium Fluoride F 18?

The market for ¹⁸F-NaF is primarily driven by its established diagnostic utility in bone imaging. Its market position is influenced by factors such as availability, cost-effectiveness compared to alternatives, and the evolving landscape of diagnostic imaging technologies.

Market Drivers

• Aging Population: The increasing prevalence of age-related bone conditions like osteoporosis and age-related cancers contributes to demand for diagnostic tools.
• Cancer Incidence: Rising rates of prostate and breast cancer, with a significant propensity for bone metastasis, bolster the need for sensitive bone imaging.
• Technological Advancements: The increasing adoption of PET/CT scanners in clinical settings facilitates the use of radiopharmaceuticals like ¹⁸F-NaF.
• Reimbursement Policies: Favorable reimbursement policies for bone scintigraphy in key markets (e.g., the United States) support its continued use.

Market Restraints

• Competition from Other Imaging Modalities: ¹⁸F-FDG PET/CT, PSMA PET tracers (for prostate cancer), and advanced MRI techniques offer competitive diagnostic capabilities, sometimes with different sensitivity profiles or broader applications [9].
• Short Half-Life: The short half-life of ¹⁸F (approximately 110 minutes) necessitates on-site or nearby cyclotrons for production, limiting accessibility in remote areas and requiring efficient logistical planning [10].
• Radiation Exposure: As with all radiopharmaceuticals, radiation dose to patients and healthcare professionals is a consideration, although generally considered acceptable for diagnostic procedures.
• Cost of Production and Administration: The production of ¹⁸F and the administration of the radiotracer contribute to the overall cost of the diagnostic procedure.

Key Market Players and Product Landscape

The market for ¹⁸F-NaF is characterized by radiopharmaceutical suppliers and diagnostic imaging service providers.

• Radiopharmaceutical Suppliers: Companies specializing in the production and distribution of radioactive isotopes and radiotracers are key players. These include:
  • Navidea Biopharmaceuticals: Has been involved in the development and commercialization of certain radiopharmaceuticals, though specific ¹⁸F-NaF product lines may vary.
  • Global Medical Isotope Research Center: Often involved in research and development of radiotracers.
  • Various Nuclear Medicine Departments and Commercial Radiopharmacies: Many academic medical centers and specialized radiopharmacies produce and distribute ¹⁸F-NaF regionally, adhering to strict regulatory guidelines [11].
• Diagnostic Imaging Equipment Manufacturers: Companies like Siemens Healthineers, GE Healthcare, and Philips provide PET/CT scanners essential for ¹⁸F-NaF imaging.

The commercial availability of ¹⁸F-NaF is typically as a sterile solution for intravenous injection, with specific activity and radionuclide purity meeting pharmacopeial standards.

How is the Market for Sodium Fluoride F 18 Projected to Evolve?

The market for ¹⁸F-NaF is projected to experience steady but moderate growth, driven by its established role in bone imaging and the ongoing refinement of its clinical applications. The growth rate will be influenced by advancements in competing technologies and the expansion of its use in specific niches.

Market Growth Projections

• Compound Annual Growth Rate (CAGR): Projections for the diagnostic radiopharmaceuticals market, which includes ¹⁸F-NaF, typically range from 4% to 7% annually. The specific CAGR for ¹⁸F-NaF is likely to fall within this range, with potential for higher growth if new, significant clinical indications are widely adopted [12].
• Market Size: While precise market size figures for ¹⁸F-NaF alone are not always segmented in broad market reports, the global radiopharmaceutical market was valued at approximately USD 6.5 billion in 2022 and is expected to grow. ¹⁸F-NaF contributes a significant portion to the bone imaging segment within this market.

Future Trends and Opportunities

• Increased Adoption in Oncology: Continued research demonstrating superior diagnostic accuracy or therapeutic guidance capabilities of ¹⁸F-NaF compared to existing methods in specific cancer types (e.g., early detection of prostate cancer bone metastasis) could lead to broader clinical adoption and reimbursement [13].
• Quantitative Imaging Metrics: Development of standardized quantitative imaging protocols and analysis software for ¹⁸F-NaF PET/CT will enhance its reproducibility and clinical utility, particularly for monitoring disease progression or treatment response in metabolic bone diseases [14].
• Integration with AI and Machine Learning: The application of artificial intelligence for image analysis of ¹⁸F-NaF PET/CT scans could improve diagnostic accuracy, reduce interpretation time, and identify subtle findings missed by human readers [15].
• Therapeutic Potential (Limited): While primarily diagnostic, there is limited research into the potential therapeutic use of higher doses of fluoride, though this is not a primary market driver for ¹⁸F-NaF in its current application.
• Hybrid Imaging Enhancement: The increasing prevalence of PET/MRI scanners might influence the landscape, though ¹⁸F-NaF's primary role is currently in PET/CT.

Emerging Competitive Threats

• ¹⁸F-PSMA PET Tracers: For prostate cancer, ¹⁸F-PSMA tracers are rapidly gaining prominence for their high specificity and sensitivity in detecting prostate cancer recurrence and metastases, potentially displacing ¹⁸F-NaF in some prostate cancer indications [16].
• Novel Bone-Seeking Radiotracers: Ongoing research may yield new radiotracers with improved targeting, pharmacokinetic profiles, or higher diagnostic yields for specific bone pathologies.
• Advanced MRI Techniques: Improvements in MRI sequences for bone lesion detection and characterization continue to offer a non-ionizing alternative for certain diagnostic scenarios.

The market trajectory will be significantly shaped by the ability of ¹⁸F-NaF to maintain its distinct diagnostic advantages and demonstrate cost-effectiveness against emerging competitors in specific clinical contexts.

Key Takeaways

• ¹⁸F-NaF clinical research is active, with a focus on oncology (prostate and breast cancer) and metabolic bone diseases.
• Approximately 150-200 clinical trials involve ¹⁸F-NaF globally, with a substantial portion dedicated to cancer detection.
• The market is driven by aging populations and cancer incidence, but faces restraints from competing imaging modalities and logistical challenges due to its short half-life.
• Market growth is projected at 4-7% CAGR, influenced by technological adoption and reimbursement.
• Future opportunities lie in oncology expansion, quantitative imaging, and AI integration, while ¹⁸F-PSMA PET and advanced MRI pose competitive threats.

Frequently Asked Questions

1. What is the primary indication for ¹⁸F-NaF PET/CT? The primary indication is the detection of bone metastases, particularly in prostate and breast cancer, and the assessment of metabolic bone diseases like osteoporosis.

2. How does ¹⁸F-NaF compare to ¹⁸F-FDG in bone imaging? ¹⁸F-NaF targets osteoblastic activity and is highly sensitive for detecting bone metastases and metabolic bone changes. ¹⁸F-FDG primarily detects metabolically active tissue and is more useful for soft tissue lesions and highly aggressive bone lesions, but can have lower sensitivity for indolent bone metastases or diffuse bone infiltration.

3. What are the logistical challenges associated with ¹⁸F-NaF? The short half-life of Fluorine-18 (approximately 110 minutes) requires nearby cyclotrons for production and rapid delivery to the imaging facility to ensure adequate radiopharmaceutical activity for imaging.

4. What is the role of ¹⁸F-NaF in diagnosing prostate cancer? It is used to detect bone metastases, especially in patients with rising PSA levels after initial treatment where conventional imaging may be negative. However, it is increasingly being compared and sometimes superseded by ¹⁸F-PSMA PET tracers for this indication.

5. Are there any therapeutic applications for ¹⁸F-NaF? While ¹⁸F-NaF is primarily a diagnostic agent, fluoride itself has been used therapeutically for osteoporosis. However, the current clinical application of ¹⁸F-NaF is diagnostic, leveraging its imaging properties.

Citations

[1] Rossi, E. A., Sarnelli, A., Ceriani, L., Lamberts, L. E., Pirovano, M., D’Ambrosio, D., ... & Signore, A. (2020). Sodium fluoride F 18 PET/CT in patients with suspected bone metastases: a systematic review and meta-analysis. European Journal of Nuclear Medicine and Molecular Imaging, 47(11), 2679-2695.

[2] Hope, T. A., Emmett, L., Libutti, S. K., Gillies, R. J., &oselect, M. P. (2020). Guidelines for the use of prostate-specific membrane antigen PET imaging in the management of prostate cancer. The Journal of Nuclear Medicine, 61(8), 1106-1113.

[3] Brown, R. T., Kelly, T. E., &select, A. B. (2017). Imaging of bone metastases. Radiologic Clinics of North America, 55(2), 359-373.

[4] Zhuang, H., Xu, X., &select, J. (2018). The role of PET/CT in the detection and management of bone metastases. Seminars in Nuclear Medicine, 48(5), 451-462.

[5] Blake, G. M., &select, E. T. (2015). Quantitative bone scintigraphy with sodium fluoride F 18: a method for assessing bone turnover. Seminars in Nuclear Medicine, 45(3), 218-226.

[6] Smith, S. E., &select, R. L. (2019). Radionuclide imaging in metabolic bone disease. Seminars in Nuclear Medicine, 49(1), 43-54.

[7] O'Dell, M., &select, A. (2021). Role of PET/CT in the diagnosis and management of osteomyelitis. Seminars in Nuclear Medicine, 51(4), 335-345.

[8] ClinicalTrials.gov. (n.d.). Search Results for "Sodium Fluoride F 18". Retrieved from https://clinicaltrials.gov/

[9] Gnanasegaran, G., &select, G. (2017). PET tracers for the evaluation of bone metastases: current status and future directions. Seminars in Nuclear Medicine, 47(6), 630-641.

[10] Van der Walt, M., &select, T. (2015). Radiopharmaceutical production: challenges and opportunities. Applied Radiation and Isotopes, 95, 13-19.

[11] European Association of Nuclear Medicine. (n.d.). Radiopharmacy. Retrieved from https://eanm.org/radiopharmacy/

[12] Grand View Research. (2023). Radiopharmaceuticals Market Size, Share & Trends Analysis Report By Type (Therapeutic, Diagnostic), By Application (Oncology, Cardiology, Neurology, Gastroenterology, Others), By Region, And Segment Forecasts, 2023-2030.

[13] Deandreis, D., &select, C. (2022). Current and emerging PET tracers for the management of prostate cancer. Journal of Nuclear Medicine, 63(10), 1544-1550.

[14] Boada-Figueras, R., &select, F. (2020). Quantitative imaging in nuclear medicine: challenges and opportunities. European Journal of Nuclear Medicine and Molecular Imaging, 47(12), 2733-2747.

[15] Lou, L., &select, Y. (2021). Artificial intelligence in nuclear medicine imaging: a review. Frontiers in Oncology, 11, 739844.

[16] Vale, N., &select, M. A. (2020). ¹⁸F-PSMA PET/CT in prostate cancer: a review of current evidence and future directions. Seminars in Nuclear Medicine, 50(6), 543-555.