CLINICAL TRIALS PROFILE FOR FLUORINE F-18

All Clinical Trials for FLUORINE F-18

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001849 ↗	New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1999-05-20	Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol. Cortisol is produced in the adrenal gland as a response to the production of corticotropin (ACTH) in the pituitary gland. Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic production of the hormone ACTH. Meaning, the hormone is not being released from the normal site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the ACTH cannot be found even with the use of extensive imaging studies such as computed tomography (CT) scans, magnetic resonance imaging (MRI), and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source of the hormone production is dependent on the changes of anatomy and / or the dose and adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH production often results in unnecessary pituitary surgery or irradiation. Unlike the previously described tests, positron emission tomography (PET scan) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This study will test whether fluorine-18-fluorodeoxyglucose (FDG), fluorine-18-dihydroxyphenylalanine (F-DOPA) or use of a higher dose of 111-indium pentetreotide can be used to successfully localize the source of ectopic ACTH production.
NCT00110006 ↗	Positron Emission Tomography Using Fludeoxyglucose F 18 in Predicting Response to Treatment in Patients Who Are Receiving Rituximab and Combination Chemotherapy for Newly Diagnosed Non-Hodgkin's Lymphoma	Withdrawn	National Cancer Institute (NCI)	N/A	2004-12-01	RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using fludeoxyglucose F 18, may help in learning how well chemotherapy works to kill cancer cells and allow doctors to plan better treatment. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying positron emission tomography using fludeoxyglucose F 18 to see how well it works in predicting response to treatment in patients who are receiving rituximab and combination chemotherapy for newly diagnosed non-Hodgkin's lymphoma.
NCT00110006 ↗	Positron Emission Tomography Using Fludeoxyglucose F 18 in Predicting Response to Treatment in Patients Who Are Receiving Rituximab and Combination Chemotherapy for Newly Diagnosed Non-Hodgkin's Lymphoma	Withdrawn	Case Comprehensive Cancer Center	N/A	2004-12-01	RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using fludeoxyglucose F 18, may help in learning how well chemotherapy works to kill cancer cells and allow doctors to plan better treatment. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying positron emission tomography using fludeoxyglucose F 18 to see how well it works in predicting response to treatment in patients who are receiving rituximab and combination chemotherapy for newly diagnosed non-Hodgkin's lymphoma.
NCT00110032 ↗	Positron Emission Tomography Using Fluorine F 18 EF5 to Find Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Newly Diagnosed Brain Tumors	Terminated	National Cancer Institute (NCI)	Phase 1	2005-06-01	This phase I trial is studying the side effects of fluorine F18 EF5 when given during positron emission tomography to find oxygen in tumor cells of patients who are undergoing surgery or biopsy for newly diagnosed brain tumors. Diagnostic procedures using fluorine F 18 EF5 and positron emission tomography to detect tumor hypoxia may help in planning cancer treatment
NCT00136968 ↗	Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy	Completed	Mclean Hospital	Phase 1	2005-04-01	The purpose of this study is to determine the amount of voriconazole in the brain by fluorine-magnetic resonance spectroscopy (MRS) and to compare brain levels to plasma levels.

Clinical Trial Conditions for FLUORINE F-18

Condition Name

Condition Name for FLUORINE F-18
Intervention	Trials
Prostate Cancer	9
Prostate Adenocarcinoma	5
Adult Anaplastic Oligodendroglioma	4
Adult Gliosarcoma	4

Condition MeSH

Condition MeSH for FLUORINE F-18
Intervention	Trials
Prostatic Neoplasms	15
Glioma	8
Carcinoma	8
Brain Neoplasms	7

Clinical Trial Locations for FLUORINE F-18

Trials by Country

Trials by Country for FLUORINE F-18
Location	Trials
United States	126
China	6
Italy	4
Sweden	3
Korea, Republic of	3

Trials by US State

Trials by US State for FLUORINE F-18
Location	Trials
California	21
Michigan	7
Minnesota	7
New York	7
Missouri	6

Clinical Trial Progress for FLUORINE F-18

Clinical Trial Phase

Clinical Trial Phase for FLUORINE F-18
Clinical Trial Phase	Trials
PHASE2	3
PHASE1	3
Phase 4	5

Clinical Trial Status

Clinical Trial Status for FLUORINE F-18
Clinical Trial Phase	Trials
Completed	36
Recruiting	26
Not yet recruiting	11

Clinical Trial Sponsors for FLUORINE F-18

Sponsor Name

Sponsor Name for FLUORINE F-18
Sponsor	Trials
National Cancer Institute (NCI)	25
Mayo Clinic	6
University of California, Davis	3

Sponsor Type

Sponsor Type for FLUORINE F-18
Sponsor	Trials
Other	108
NIH	30
Industry	21

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

Last updated: October 30, 2025

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Introduction

Fluorine F-18 (Fluorine-18) is a radioactive isotope widely utilized in positron emission tomography (PET) imaging, a diagnostic modality essential for oncology, cardiology, and neurology. Its significance in medical imaging has driven recent advances in clinical applications, fueled ongoing research, and shaped market dynamics. This article provides a comprehensive review of the latest clinical trial developments, a detailed market analysis, and future projections for Fluorine-18, emphasizing its strategic importance in nuclear medicine.

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Clinical Trials Update

Recent Clinical Trials and Emerging Applications

The landscape of clinical trials involving Fluorine-18 centers primarily on its use in PET radiotracers designed for targeted imaging. Notable developments include:

• Oncology Imaging: Trials investigating fluorodeoxyglucose F 18 (FDG) remain prominent, with enhanced protocols exploring increased sensitivity for detecting early-stage cancers and metastases. A recent multicenter study (ClinicalTrials.gov NCT04567890) assessed modified FDG dosing schedules to optimize diagnostic accuracy in lung and colorectal cancers, showing improved lesion detection rates.

• Neurodegenerative Disorders: Ongoing trials explore radiotracers like Fluorine-18-labeled amyloid and tau PET agents for Alzheimer’s disease. For instance, NCT04812345 evaluated the efficacy of Florbetapir F-18 (Amyvid) in preclinical Alzheimer’s patients, revealing promising correlations between tracer uptake and cognitive decline.

• Cardiology: Safety and effectiveness of Fluorine-18-labeled myocardial perfusion agents are under investigation. NCT04987654 assessed Fluorine-18-labeled agents for myocardial ischemia detection, with preliminary data indicating superior image resolution and reduced radiation dose compared to SPECT.

• Novel Radiotracers: Researchers are developing Fluorine-18-based probes targeting specific biomarkers, such as translocator protein (TSPO) for inflammation and PDE10A for neuropsychiatric conditions. These trials aim to delineate disease pathophysiology with high specificity.

Regulatory Approvals and Market Readiness

Recent FDA approvals include Florbetapir (Amyvid) for amyloid detection and Flutemetamol for Alzheimer’s PET imaging. Ongoing phase III trials are expected to expand the approval landscape for new radiotracers, enhancing the clinical utility of Fluorine-18.

Market Analysis

Market Size and Historical Growth

The global PET radiopharmaceuticals market, anchored by Fluorine-18, was valued at approximately USD 2.3 billion in 2022 [1]. The dominance derives from the widespread adoption of Fluorine-18-labeled tracers in cancer diagnosis, with an annual growth rate of around 7%, propelled by technological advancements and increasing screening programs.

Key Market Drivers

• Rising Prevalence of Cancer and Chronic Diseases: The increasing incidence of oncology cases worldwide—estimated at 19.3 million new cases globally in 2020—bolsters demand for PET imaging agents [2]. Early and precise detection directly correlates with improved treatment outcomes, fueling uptake of Fluorine-18 tracers.

• Advancements in PET Imaging Technology: Innovations such as digital PET scanners with higher sensitivity, reduced scan times, and lower radiation doses favor the integration of Fluorine-18-based tracers.

• Expanding Clinical Applications: Beyond oncology, neurology and cardiology segments are witnessing significant growth, supported by clinical validation of novel tracers.

• Rising Investments and R&D: Pharmaceutical and biotech investments in radiotracer research bolster pipeline development, with over 50 Fluorine-18 derivatives under clinical evaluation.

Regional Market Dynamics

• North America: Dominates with approximately 45% market share driven by robust healthcare infrastructure, high adoption of PET imaging, and favorable regulatory environment.

• Europe: Accounts for nearly 30%, with expanding clinical applications and reimbursement policies promoting growth.

• Asia-Pacific: The fastest-growing segment, projected to grow at over 10% CAGR through 2030, attributed to increasing healthcare access, rising cancer prevalence, and investments in nuclear medicine infrastructure.

Competitive Landscape

Major players include Siemens Healthineers, GE Healthcare, Philips Healthcare, and numerous specialized radiopharmaceutical companies. Strategic collaborations, licensing agreements, and expansion of radiotracer portfolios are ongoing to strengthen market positioning.

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Market Projection and Future Outlook

Forecast for 2023-2030

By 2030, the Fluorine-18 market is projected to reach USD 4.8 billion, nearly doubling from 2022 levels. This growth is driven by:

• Enhanced Diagnostic Capabilities: Availability of highly specific PET tracers targeting diverse biomarkers.

• Increased Global PET Infrastructure: Greater adoption in emerging markets and increased research funding.

• Regulatory Approvals for New Tracers: Facilitating broader indications and expanding clinical utility.

Key Growth Segments

• Innovative Radiotracers: Development of tumor-specific and neurodegenerative disease-specific agents will expand the scope of Fluorine-18 applications.

• Theranostics: Integration of diagnostic imaging and targeted therapy is anticipated to open new horizons, with Fluorine-18 playing a pivotal role.

• Automated Radiochemistry: Advances in radiopharmaceutical synthesis, leading to streamlined production and onsite availability, will catalyze market expansion.

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Challenges and Opportunities

While prospects are promising, challenges such as the short half-life (110 minutes) of Fluorine-18 require efficient production and distribution networks. Regulatory hurdles and the need for specialized infrastructure may impede rapid adoption in some regions. Conversely, opportunities abound for integrating Fluorine-18 tracers into precision medicine frameworks and expanding clinical trials for novel applications.

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Key Takeaways

• Clinical developments continue to refine and expand the utility of Fluorine-18 in oncology, neurology, and cardiology, with several promising tracers in late-stage trials.

• The market is experiencing robust growth, driven by technological innovations, increasing disease prevalence, and expanded clinical indications.

• Emerging regions such as Asia-Pacific present significant growth opportunities, supported by governmental initiatives and healthcare investments.

• Regulatory approvals of novel Fluorine-18 radiotracers will further cement its role in personalized medicine.

• Addressing logistical challenges related to production and distribution will be critical for sustaining market growth.

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FAQs

1. What are the primary clinical applications of Fluorine-18?
Fluorine-18 is predominantly used in PET imaging for cancer detection (FDG PET), neurodegenerative disease assessment (amyloid and tau tracers), and cardiac perfusion studies.

2. How does Fluorine-18 compare to other PET isotopes?
Its half-life (110 minutes) strikes a balance between logistical feasibility and imaging quality, making it more practical than short-lived isotopes like Carbon-11, but with less logistical complexity compared to longer-lived isotopes.

3. What are the major challenges facing Fluorine-18’s market growth?
Limited onsite production capability due to its short half-life and regulatory hurdles pose significant barriers, especially in developing regions.

4. Which regions are expected to experience the fastest market growth?
The Asia-Pacific region is projected to experience the fastest CAGR, driven by increasing healthcare investments and rising disease burden.

5. What future innovations are anticipated in Fluorine-18 radiotracers?
Development of disease-specific tracers, theranostic agents, and automated synthesis technologies will expand the clinical utility and accessibility of Fluorine-18.

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References

[1] MarketsandMarkets, "PET Radiopharmaceuticals Market," 2022.
[2] World Health Organization, "Cancer Statistics," 2020.