CLINICAL TRIALS PROFILE FOR FLUORINE F-18

All Clinical Trials for FLUORINE F-18

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00136968 ↗	Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy	Completed	Pfizer	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.
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in Patients Who Are Receiving Rituximab and Combination Chemotherapy for Newly Diagnosed Non-Hodgkin's Lymphoma	Withdrawn	National Cancer Institute (NCI)	N/A	2004-12-01	RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using fludeoxyglucose F 18, may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.
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.

Clinical Trial Conditions for FLUORINE F-18

Condition Name

Condition Name for FLUORINE F-18
Intervention	Trials
Prostate Cancer	9
Adult Gliosarcoma	4
Adult Mixed Glioma	4
Adult Giant Cell Glioblastoma	4

Condition MeSH

Condition MeSH for FLUORINE F-18
Intervention	Trials
Prostatic Neoplasms	13
Carcinoma	8
Brain Neoplasms	7
Glioma	7

Clinical Trial Locations for FLUORINE F-18

Trials by Country

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Trials by Country for FLUORINE F-18
Location	Trials
United States	121
China	6
Italy	4
Korea, Republic of	3
Germany	3

Trials by US State

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

Clinical Trial Progress for FLUORINE F-18

Clinical Trial Phase

Clinical Trial Phase for FLUORINE F-18
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	3
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for FLUORINE F-18
Clinical Trial Phase	Trials
Completed	35
Recruiting	23
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)	24
Mayo Clinic	6
CellSight Technologies, Inc.	3

Sponsor Type

Sponsor Type for FLUORINE F-18
Sponsor	Trials
Other	100
NIH	29
Industry	21

Fluorine-18: Clinical Trials, Market Analysis, and Projections

Introduction to Fluorine-18

Fluorine-18, a radioactive isotope of fluorine, is widely used in positron emission tomography (PET) imaging due to its favorable physical and chemical properties. It has a half-life of approximately 110 minutes, making it ideal for medical imaging applications.

Clinical Trials Update

Myocardial Perfusion Imaging with Fluorine-18 Flurpiridaz

A significant clinical trial involves the use of Fluorine-18 flurpiridaz for myocardial perfusion imaging in the detection and evaluation of coronary artery disease (CAD). This phase III multicenter study enrolled 795 patients and compared the diagnostic efficacy of flurpiridaz PET with technetium-99m-labeled single photon emission computed tomography (SPECT)[1].

• Key Findings:
  • The sensitivity of flurpiridaz PET for detecting ≥50% stenosis by invasive coronary angiography (ICA) was 71.9%, significantly higher than SPECT (53.7%).
  • Although specificity did not meet the prespecified noninferiority criterion, flurpiridaz PET showed superior discrimination of CAD, especially in women, obese patients, and those undergoing pharmacological stress testing.
  • Flurpiridaz PET also offered better image quality, diagnostic certainty, and lower radiation exposure compared to SPECT.

Prostate Cancer Staging with Fluorine-18 PSMA-1007

Another notable trial involves the use of Fluorine-18 prostate-specific membrane antigen–1007 (18F-PSMA-1007) PET/CT for the locoregional staging of intermediate-risk and high-risk prostate cancers. This phase 2 prospective validating paired cohort study compared 18F-PSMA-1007 PET/CT with multiparametric MRI[4].

• Key Findings:
  • 18F-PSMA-1007 PET/CT correctly identified the final pathological tumor stage in 45% of patients, compared to 28% with multiparametric MRI.
  • The study highlighted the superior accuracy of 18F-PSMA-1007 PET/CT in detecting intraprostatic tumor nodules and lymph node metastasis.

Market Analysis

The Fluorine-18 market is experiencing significant growth driven by several key factors.

Market Size and Growth

• The Fluorine-18 market is projected to reach USD 2.41 billion by 2030, growing at a CAGR of 4.3% from 2022 to 2030[2].
• Alternatively, some reports suggest the market could cross USD 3 billion by 2031, expanding at a CAGR of 7.5% from 2021 to 2031[5].

Market Segmentation

• Product Type:
  • The market is segmented into FDG, NaF, and others. The FDG segment holds the largest market share and is expected to register the highest CAGR during the forecast period[2][5].
• Application:
  • The market is divided into oncology, cardiology, neurology, and others. Oncology holds the largest market share and is anticipated to register the highest CAGR[2][5].
• End User:
  • The market is categorized into hospitals, diagnostic centers, and others. Hospitals hold the largest market share and are expected to register the highest CAGR[2][5].

Geographic Distribution

• The Fluorine-18 market is analyzed across regions including North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Each region is expected to contribute significantly to the market growth driven by increasing healthcare infrastructure and technological advancements[5].

Market Drivers and Challenges

Drivers

• Increasing Prevalence of Chronic Diseases: The rising incidence of chronic diseases such as cancer and cardiovascular diseases is driving the demand for advanced diagnostic techniques, including PET imaging[2][5].
• Technological Advancements: Innovations in radiotracer development, production techniques, and hybrid imaging are enhancing the market's potential[5].
• Aging Population: The growing aging population is contributing to an increased need for diagnostic imaging services[5].

Challenges

• Short Shelf-Life: The short half-life of Fluorine-18 (approximately 110 minutes) poses logistical challenges in production, distribution, and use[2].

Future Trends and Projections

Expanding Applications

• Oncology: The use of Fluorine-18 in cancer diagnosis, particularly with tracers like FDG and PSMA-1007, is expected to continue growing. These tracers offer high accuracy in detecting and staging cancers[2][4].
• Cardiology: The adoption of Fluorine-18 flurpiridaz for myocardial perfusion imaging is anticipated to increase, especially in populations where traditional SPECT has limitations, such as women and obese patients[1].

Technological Innovations

• Hybrid Imaging: The integration of PET with other imaging modalities like CT and MRI is expected to enhance diagnostic accuracy and patient outcomes[5].

Regulatory and Clinical Trials

• Ongoing and future clinical trials will play a crucial role in expanding the approved indications for Fluorine-18-based tracers. For instance, the ongoing phase III trial for flurpiridaz will further establish its efficacy and safety[1].

"Fluorine-18 flurpiridaz PET myocardial perfusion imaging shows promise as a new tracer for CAD detection and assessment of women, obese patients, and patients undergoing pharmacological stress testing."[1]

Key Takeaways

• Fluorine-18 is a critical isotope in PET imaging, with significant applications in oncology and cardiology.
• Clinical trials, such as those involving flurpiridaz and PSMA-1007, are advancing the diagnostic capabilities of Fluorine-18-based tracers.
• The Fluorine-18 market is projected to grow substantially, driven by increasing demand for advanced diagnostic techniques and technological innovations.
• Despite challenges like the short shelf-life, the market is expected to expand across various regions and applications.

FAQs

Q: What is the primary use of Fluorine-18 in medical imaging?

A: Fluorine-18 is primarily used in positron emission tomography (PET) imaging for various applications, including cancer diagnosis and myocardial perfusion imaging.

Q: How does Fluorine-18 flurpiridaz compare to SPECT in detecting coronary artery disease?

A: Fluorine-18 flurpiridaz PET shows higher sensitivity and better image quality compared to SPECT, especially in women, obese patients, and those undergoing pharmacological stress testing[1].

Q: What are the key drivers of the Fluorine-18 market growth?

A: The market growth is driven by the increasing prevalence of chronic diseases, technological advancements, an aging population, and the expansion of healthcare infrastructure[2][5].

Q: What are the challenges associated with the use of Fluorine-18?

A: The primary challenge is the short half-life of Fluorine-18, which poses logistical challenges in production, distribution, and use[2].

Q: What are the future trends in the Fluorine-18 market?

A: Future trends include expanding applications in oncology and cardiology, technological innovations in hybrid imaging, and ongoing clinical trials to establish new indications for Fluorine-18-based tracers[1][5].

Sources

1. Phase-III Clinical Trial of Fluorine-18 Flurpiridaz Positron Emission Tomography for Myocardial Perfusion Imaging. PubMed, 2020.
2. Fluorine-18 Market to Grow at a CAGR of 4.3% by 2030. The Insight Partners, 2024.
3. Clinical Trials Using Fluorine F 18 Fluorthanatrace. National Cancer Institute, 2023.
4. Fluorine-18 Prostate-Specific Membrane Antigen–1007 PET/CT vs Multiparametric MRI for Prostate Cancer Staging. JAMA Oncology, 2024.
5. Fluorine-18 Market Size Will Estimated to Cross USD 3 Billion, Expanding at a CAGR of 7.5% by 2031. Transparency Market Research, 2024.