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Last Updated: April 4, 2025

CLINICAL TRIALS PROFILE FOR SODIUM FLUORIDE F-18


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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 TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
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.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 1 of 1 entries

All Clinical Trials for sodium fluoride f-18

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for sodium fluoride f-18

Condition Name

13987002468101214Dental CariesDentin SensitivityDental Caries in ChildrenEarly Childhood Caries[disabled in preview]
Condition Name for sodium fluoride f-18
Intervention Trials
Dental Caries 13
Dentin Sensitivity 9
Dental Caries in Children 8
Early Childhood Caries 7
[disabled in preview] 0
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Condition MeSH

2514141300510152025Dental CariesHypersensitivityDentin SensitivityProstatic Neoplasms[disabled in preview]
Condition MeSH for sodium fluoride f-18
Intervention Trials
Dental Caries 25
Hypersensitivity 14
Dentin Sensitivity 14
Prostatic Neoplasms 13
[disabled in preview] 0
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Clinical Trial Locations for sodium fluoride f-18

Trials by Country

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Trials by Country for sodium fluoride f-18
Location Trials
United States 183
Canada 11
Brazil 11
Egypt 9
China 8
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Trials by US State

+
Trials by US State for sodium fluoride f-18
Location Trials
Indiana 17
Maryland 12
New York 9
New Jersey 8
California 7
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Clinical Trial Progress for sodium fluoride f-18

Clinical Trial Phase

23.0%27.6%9.2%40.2%0101520253035Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for sodium fluoride f-18
Clinical Trial Phase Trials
Phase 4 20
Phase 3 24
Phase 2/Phase 3 8
[disabled in preview] 35
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Clinical Trial Status

67.9%8.9%8.9%14.3%01020304050607080CompletedRecruitingNot yet recruiting[disabled in preview]
Clinical Trial Status for sodium fluoride f-18
Clinical Trial Phase Trials
Completed 76
Recruiting 10
Not yet recruiting 10
[disabled in preview] 16
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Clinical Trial Sponsors for sodium fluoride f-18

Sponsor Name

trials0246810121416GlaxoSmithKlineNational Cancer Institute (NCI)Colgate Palmolive[disabled in preview]
Sponsor Name for sodium fluoride f-18
Sponsor Trials
GlaxoSmithKline 15
National Cancer Institute (NCI) 13
Colgate Palmolive 9
[disabled in preview] 13
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Sponsor Type

59.3%30.9%9.9%00102030405060708090100OtherIndustryNIH[disabled in preview]
Sponsor Type for sodium fluoride f-18
Sponsor Trials
Other 96
Industry 50
NIH 16
[disabled in preview] 0
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Sodium Fluoride F-18: Clinical Trials, Market Analysis, and Projections

Introduction

Sodium Fluoride F-18, a radiopharmaceutical, is widely used in positron emission tomography (PET) scans, particularly for diagnosing and monitoring various medical conditions, including bone metastases and certain types of cancer. Here, we delve into the current state of clinical trials, market analysis, and future projections for this crucial diagnostic tool.

Clinical Trials and Applications

Current Clinical Uses

Sodium Fluoride F-18 is primarily used in PET scans to detect bone metastases and other skeletal disorders. It is approved for marketing and has been in use since 1972, with no significant adverse reactions reported in extensive patient studies[5].

Ongoing and Future Clinical Trials

Clinical trials involving Sodium Fluoride F-18 are ongoing, focusing on its efficacy in various medical specialties. For instance, the National Cancer Institute (NCI) is involved in studies that explore the use of Sodium Fluoride F-18 in combination with other therapies for treating conditions like hereditary leiomyomatosis and renal cell cancer[4].

Expanding Applications

Beyond oncology, Sodium Fluoride F-18 is being explored in other non-oncologic specialties such as cardiology, neurology, and cognitive neuroscience. This expansion in clinical applications is expected to drive the demand for this radiopharmaceutical[2].

Market Analysis

Global Market Size and Growth

The global market for Sodium Fluoride F-18, as part of the broader fluorine-18 market, was valued at approximately $1.4 billion in 2020. It is projected to reach $3 billion by 2030, growing at a compound annual growth rate (CAGR) of 7.4% from 2021 to 2030[2].

Regional Market Insights

North America currently dominates the global fluorine-18 market, followed by Europe. However, the Asia Pacific region is expected to experience significant growth due to increasing demand for PET-CT machines in hospitals and diagnostic centers, particularly in countries like China and India[2].

End User Segmentation

The market is segmented by end users, with hospitals being the major consumers. The demand for PET-CT machines in new hospital projects globally is a key driver for the growth in this segment[2].

Market Drivers

Increasing Demand for PET-CT Scans

The rising incidence of cancer and other diseases that require advanced diagnostic techniques is driving the demand for PET-CT scans. Combined PET/CT scanners, which offer more accurate diagnoses than separate scans, are a significant factor in this growth[2].

Expanding Clinical Applications

The use of Sodium Fluoride F-18 beyond oncology, in specialties like cardiology and neurology, is expanding its market reach. This diversification in clinical applications is expected to contribute to the market's growth[2].

Infrastructure and Healthcare Expenditure

Infrastructure expansions and increased healthcare expenditure, especially in the Asia Pacific region, are also contributing to the market's positive outlook. Rapid urbanization and development patterns in this region are further bolstering demand[1].

Competitive Landscape

Key Players

The market for Sodium Fluoride F-18 is competitive, with several key players including Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications (a Novartis AG Company), GE Healthcare, and Blue Earth Diagnostics. These companies are engaged in product launches, acquisitions, and geographical expansions to maintain their market share[2].

Market Share and Revenue

The report provides detailed insights into the market share, revenue, and production patterns of these key players. It also includes SWOT analysis and pricing models, which are crucial for understanding the competitive dynamics[2].

Regulatory Framework

Compliance and Standards

Sodium Fluoride F-18 Injection complies with the United States Pharmacopeia (USP) monograph and is manufactured following procedures that conform to the radiopharmaceuticals for PET compounding standards (USP <823>)[5].

Safety and Efficacy

The drug has been approved for marketing since 1972, with no significant adverse reactions reported. It is provided as a ready-to-use, isotonic, sterile, pyrogen-free, clear and colorless solution[5].

Future Projections

Market Growth

The global fluorine-18 market, including Sodium Fluoride F-18, is expected to continue its robust growth trajectory. The CAGR of 7.4% from 2021 to 2030 indicates a strong future for this market[2].

Technological Advancements

Advancements in PET-CT technology and the integration of AI in diagnostic imaging are likely to further enhance the accuracy and efficiency of Sodium Fluoride F-18 in clinical settings.

Emerging Markets

The Asia Pacific region, particularly countries like China and India, will play a significant role in the future growth of the market due to their burgeoning healthcare infrastructure and increasing demand for advanced diagnostic tools[2].

Key Takeaways

  • Clinical Trials: Ongoing trials are exploring the use of Sodium Fluoride F-18 in various medical specialties beyond oncology.
  • Market Growth: The global market is projected to reach $3 billion by 2030, growing at a CAGR of 7.4% from 2021 to 2030.
  • Regional Insights: North America dominates the market, but the Asia Pacific region is expected to experience significant growth.
  • End User Demand: Hospitals are the major consumers, driven by the increasing demand for PET-CT machines.
  • Competitive Landscape: Key players are engaged in strategic activities to maintain market share.

FAQs

What is the primary use of Sodium Fluoride F-18 in medical diagnostics?

Sodium Fluoride F-18 is primarily used in PET scans to detect bone metastases and other skeletal disorders.

Which regions are expected to drive the growth of the Sodium Fluoride F-18 market?

North America currently dominates the market, but the Asia Pacific region is expected to experience significant growth due to increasing demand for PET-CT machines.

What is the projected market size of the global fluorine-18 market by 2030?

The global fluorine-18 market, including Sodium Fluoride F-18, is expected to reach $3 billion by 2030.

Who are the key players in the Sodium Fluoride F-18 market?

Key players include Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications, GE Healthcare, and Blue Earth Diagnostics.

What are the emerging applications of Sodium Fluoride F-18 beyond oncology?

Sodium Fluoride F-18 is being explored in cardiology, neurology, and cognitive neuroscience, expanding its clinical applications beyond oncology.

Sources

  1. Global Sodium Fluoride Market Projected to Reach US$915.781 Million by 2029 - GlobeNewswire
  2. Fluorine-18 Market Size Worth Around US$ 3 Billion by 2030 - BioSpace
  3. 022494Orig1s000 - accessdata.fda.gov
  4. Clinical Trials Using Fluorine F 18 Sodium Fluoride - NCI
  5. SODIUM FLUORIDE F 18 INJECTION - Cancer Imaging Program

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