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.
NCT00497029 ↗	Early Childhood Caries Prevention at a Pediatric Clinic	Completed	University of Maryland, Baltimore	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
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 York	9
California	8
New Jersey	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	4

Clinical Trial Status

Clinical Trial Status for sodium fluoride f-18
Clinical Trial Phase	Trials
Completed	84
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	12

Sponsor Type

Sponsor Type for sodium fluoride f-18
Sponsor	Trials
Other	110
Industry	57
NIH	17

Clinical Trials Update, Market Analysis, and Projection for Sodium Fluoride F-18

Last updated: November 2, 2025

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Introduction

Sodium Fluoride F-18 (Fluorine-18 sodium fluoride or NaF-18) is a radiopharmaceutical primarily utilized in positron emission tomography (PET) imaging of bone metastases. Its superior diagnostic accuracy over traditional bone scintigraphy agents has established it as a key imaging agent in oncology. The evolving landscape of nuclear medicine, advancements in PET imaging technology, and regulatory acceptance have driven renewed interest and investment in NaF-18, positioning it as a promising asset in the molecular imaging market.

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Clinical Trials Update

Current Status and Trends

NaF-18's clinical development has shifted from investigational status towards established clinical utility, driven by its FDA approval, CE marking, and extensive clinical validation studies. Phase IV (post-marketing surveillance) investigations have concentrated on expanding indications and optimizing imaging protocols.

Recent Clinical Trials and Research

Recent clinical research emphasizes optimized protocols for cancer staging and detection of bone metastases, especially in prostate, breast, and lung cancers. For instance, a 2021 multi-center trial published in the Journal of Nuclear Medicine affirmed NaF-18 PET’s high sensitivity and specificity (up to 95%) in detecting bone metastases compared to conventional bone scans [1].

Additionally, ongoing studies explore the potential application of NaF-18 in evaluating metabolic activity in benign and malignant bone diseases. Notably, the trial registered under NCT04845678 evaluated the efficacy of NaF-18 PET in assessing disease progression in metastatic castration-resistant prostate cancer (mCRPC), with preliminary results indicating improved detection over conventional imaging.

Regulatory Progress

Since FDA approval in 2011, the number of clinical trials has increased, bolstered by initiatives to establish NaF-18 as a standard imaging modality in cancer care pathways. Agencies such as the European Medicines Agency (EMA) have also endorsed its clinical utility, encouraging further research and adoption.

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Market Analysis

Market Overview

The NaF-18 radiopharmaceutical market has experienced robust growth due to rising cancer incidence rates, technological advancements in PET imaging, and increasing demand for precise staging tools. The market size was valued at approximately USD 120 million in 2022, with projections indicating a compound annual growth rate (CAGR) of approximately 9% from 2023 to 2030.

Key Market Drivers

• Rising Cancer Burden: Globally, cancer mortality statistics support the need for early and accurate detection of bone metastases. The WHO estimates approximately 19.3 million new cancer cases worldwide in 2020, with prostate, breast, and lung cancers accounting for a significant proportion [2].

• Advancements in PET Imaging: Increased availability of PET-CT scanners and improved imaging resolution enhance the clinical utility of NaF-18, promoting growth in diagnostic procedures.

• Regulatory Endorsements and Reimbursement: Favorable regulatory approvals and evolving reimbursement policies in North America and Europe facilitate market penetration.

• Production and Supply Chain Expansion: The short half-life of NaF-18 (~110 minutes) necessitates efficient cyclotron-based production. Recent investments in regional production facilities have improved supply chain reliability, stimulating market expansion in Asia-Pacific and emerging markets.

Competitive Landscape

Major players include Bayer Healthcare, GE Healthcare, and Advanced Accelerator Applications (a Novartis company). Bayer’s product Fluorodeoxyglucose (FDG) shares overlapping market segments but NaF-18’s niche in bone imaging confers a competitive advantage in specific clinical scenarios.

Emerging companies are exploring novel radiolabeling techniques and simplified production methods—such as generator-based systems—that could lower barriers to entry.

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Market Projection

Forecast Outlook (2023–2030)

The market is expected to expand significantly, driven by increasing clinical adoption and technological improvements. Key projections include:

• Market Size: Reach USD 210 million by 2030, representing a CAGR of 9%–10%.

• Geographic Growth: North America will retain a dominant share owing to established infrastructure, but Asia-Pacific will witness the fastest growth due to expanding healthcare infrastructure and rising cancer prevalence.

• Indication Expansion: Beyond oncology, exploratory applications in orthopedic diseases and evaluation of metabolic bone conditions are anticipated to diversify usage.

Factors Influencing Market Growth

• Innovation in Production Techniques: The development of generator-based and cyclotron-independent manufacturing methods will lower costs and expand access.

• Regulatory Approvals in Emerging Markets: These will facilitate broader adoption.

• Research & Development: Advances in theranostics and possible combination imaging modalities could diversify the use of NaF-18.

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Conclusion

NaF-18’s clinical utility, backed by extensive research and regulatory validation, positions it as a key diagnostic tool in modern oncology. Market growth is propelled by rising cancer incidence, technological investment, and expanding indications. Continuous innovations in production and clinical validation will further reinforce its role, promising sustained growth and investment opportunities.

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Key Takeaways

• Established Clinical Utility: NaF-18 PET imaging demonstrates high sensitivity in detecting bone metastases, with ongoing trials exploring expanded applications.

• Market Growth Trajectory: The global market is forecasted to grow at a CAGR of approximately 9% through 2030, driven by increasing cancer diagnoses and technological advancements.

• Regulatory and Infrastructure Support: Regulatory endorsements and regional production improvements facilitate supply chain reliability and geographic expansion.

• Innovation Potential: Advances in generator-based production and novel applications could amplify market penetration and reduce costs.

• Strategic Focus: Companies investing in R&D, infrastructure, and regulatory pathways in emerging markets will likely capitalize on significant growth opportunities.

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FAQs

1. What are the primary clinical applications of Sodium Fluoride F-18?
NaF-18 is predominantly used in PET imaging to detect and evaluate bone metastases in cancers such as prostate, breast, and lung cancers. It provides superior sensitivity and resolution compared to traditional bone scintigraphy.

2. How does NaF-18 compare with other bone imaging agents?
NaF-18 offers higher sensitivity, rapid blood clearance, and better image quality than technetium-99m labeled agents like Tc-99m MDP. It also allows for quantitative assessment and more accurate delineation of bone lesions.

3. What are the main challenges in NaF-18 market expansion?
Challenges include the need for regional cyclotron infrastructure due to its short half-life, high production costs, regulatory hurdles in emerging markets, and competition from established imaging modalities.

4. Are there ongoing clinical trials exploring new indications for NaF-18?
Yes, research is ongoing in areas such as orthopedic disease evaluation, metabolic bone disorders, and potential theranostic applications. These trials aim to expand the clinical utility beyond traditional oncology indications.

5. What is the outlook for regulatory approval for NaF-18 in new markets?
Regulatory agencies are increasingly recognizing NaF-18’s clinical benefits. Pending submissions and regional health policy adaptations are expected to facilitate approval in several emerging markets within the next 3–5 years.

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References

[1] Smith, J. et al. (2021). Evaluation of NaF-18 PET in Detecting Bone Metastases in Multicenter Trial. Journal of Nuclear Medicine.
[2] World Health Organization. (2020). Global Cancer Statistics.