CLINICAL TRIALS PROFILE FOR FLUORODOPA F-18

All Clinical Trials for fluorodopa f-18

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01991977 ↗	18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2013-12-01	This phase II trial studies how well fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) works in finding tumors in patients with newly diagnosed gliomas undergoing radiation therapy. Comparing results of diagnostic procedures done before and during radiation therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
NCT01991977 ↗	18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy	Active, not recruiting	Mayo Clinic	Phase 2	2013-12-01	This phase II trial studies how well fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) works in finding tumors in patients with newly diagnosed gliomas undergoing radiation therapy. Comparing results of diagnostic procedures done before and during radiation therapy may help doctors predict a patient's response to treatment and help plan the best treatment.
NCT01165632 ↗	Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma	Active, not recruiting	National Cancer Institute (NCI)	Early Phase 1	2010-07-26	RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment. PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma
NCT01165632 ↗	Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma	Active, not recruiting	Mayo Clinic	Early Phase 1	2010-07-26	RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment. PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma
NCT00674440 ↗	Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism	Completed	University of Pennsylvania	Phase 2	2004-12-01	Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.
NCT00674440 ↗	Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism	Completed	Children's Hospital of Philadelphia	Phase 2	2004-12-01	Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.

Clinical Trial Conditions for fluorodopa f-18

Condition Name

Condition Name for fluorodopa f-18
Intervention	Trials
Malignant Glioma	4
Glioblastoma	3
Adult Brain Stem Glioma	2
Adult Subependymal Giant Cell Astrocytoma	2

Condition MeSH

Condition MeSH for fluorodopa f-18
Intervention	Trials
Glioma	7
Glioblastoma	5
Hyperinsulinism	2
Congenital Hyperinsulinism	2

Clinical Trial Locations for fluorodopa f-18

Trials by Country

+

−

Trials by Country for fluorodopa f-18
Location	Trials
United States	13

Trials by US State

+

−

Trials by US State for fluorodopa f-18
Location	Trials
Minnesota	5
Pennsylvania	3
Texas	2
Arizona	1
Missouri	1

Clinical Trial Progress for fluorodopa f-18

Clinical Trial Phase

Clinical Trial Phase for fluorodopa f-18
Clinical Trial Phase	Trials
Phase 2	6
Phase 1	3
N/A	1

Clinical Trial Status

Clinical Trial Status for fluorodopa f-18
Clinical Trial Phase	Trials
Active, not recruiting	4
Terminated	3
Not yet recruiting	2

Clinical Trial Sponsors for fluorodopa f-18

Sponsor Name

Sponsor Name for fluorodopa f-18
Sponsor	Trials
National Cancer Institute (NCI)	5
Mayo Clinic	5
Washington University School of Medicine	1

Sponsor Type

Sponsor Type for fluorodopa f-18
Sponsor	Trials
Other	15
NIH	5

Fluorodopa F-18: Clinical Trials, Market Analysis, and Projections

What is Fluorodopa F-18?

Fluorodopa F-18 is a radiopharmaceutical used for the visual detection of certain nerve cells in adult patients with suspected Parkinsonian Syndromes (PS). It is administered intravenously and used in conjunction with Positron Emission Tomography (PET) scans to help diagnose PS by detecting damaged or lost dopaminergic nerve cells in the brain[1].

Clinical Trials

Trial Design and Participants

The FDA approved Fluorodopa F-18 based on evidence from a single clinical trial involving 56 patients with suspected PS. This trial was conducted at one clinical site in the United States. All patients received a single intravenous dose of Fluorodopa F-18 before undergoing a PET scan. The images from the PET scan were read by three independent readers who were blinded to the patients' clinical conditions[1].

Efficacy Results

The primary outcome of the trial was the positive and negative percent agreement of the Fluorodopa F-18 PET image results with the reference clinical diagnostic standard of PS. The results showed varying degrees of agreement among the readers:

• Reader 1: 73% positive agreement (95% CI: 55, 87) and 91% negative agreement (95% CI: 72, 99)
• Reader 2: 49% positive agreement (95% CI: 31, 67) and 91% negative agreement (95% CI: 72, 99)
• Reader 3: 58% positive agreement (95% CI: 39, 75) and 83% negative agreement (95% CI: 61, 94)[1].

Safety Results

No adverse reactions were reported in the clinical trial, which means that subgroup differences in side effects among sex, race, and age groups could not be evaluated[1].

Market Analysis

Global Fluorine-18 Market Overview

The global fluorine-18 market, which includes Fluorodopa F-18, was valued at over US$ 1.4 billion in 2020 and is projected to reach US$ 3 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 7.4% from 2021 to 2030[5].

Market Segmentation

The global fluorine-18 market is segmented based on product and end-user.

By Product

• The market is primarily driven by the demand for Fluorodeoxyglucose (FDG), which is the most widely used PET-radiopharmaceutical. The FDG segment is expected to account for a major share of the global market by 2030 due to the increasing demand for PET/CT scans in oncology[5].
• Other segments include Sodium Fluoride (NaF) and other radiopharmaceuticals.

By End-User

• Hospitals are expected to be the major end-users, driven by the increasing demand for the installation of new PET-CT machines in upcoming hospital projects globally[5].
• Diagnostic centers and other healthcare facilities also contribute significantly to the market.

Regional Analysis

The global fluorine-18 market is segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

• North America dominated the global market in 2020, followed by Europe. This region is expected to continue its dominance due to advanced healthcare infrastructure and high adoption rates of PET/CT technologies[5].
• Asia Pacific is projected to expand at a high CAGR from 2021 to 2030, driven by increasing healthcare spending and rising demand for diagnostic procedures in countries like India and China[2][5].

Market Projections

Growth Drivers

• The increasing prevalence of diseases such as cancer, Alzheimer’s, and cardiovascular diseases is driving the demand for more precise diagnostic tools, including PET scans[2].
• Rising health awareness and the growing preference for PET/CT scans are key factors propelling market growth[2].
• The expansion of healthcare infrastructure in developing regions, particularly in Asia Pacific, offers significant opportunities for the growth of the fluorine-18 market[2][5].

Market Size and CAGR

The global fluorine-18 market is expected to grow from US$ 1.4 billion in 2020 to US$ 3 billion by 2030, with a CAGR of 7.4% from 2021 to 2030[5].

Key Players

Major players in the global fluorine-18 market include Lantheus Holdings, Inc., Siemens Healthineers, Advanced Accelerator Applications (a Novartis AG Company), GE Healthcare (General Electric Company), and Blue Earth Diagnostics (A Bracco Imaging Company)[2].

Regulatory and Patent Landscape

FDA Approval and Exclusivity

Fluorodopa F-18 was approved by the FDA on October 10, 2019. The drug is protected by FDA regulatory exclusivities, although it is not protected by any US patents. The earliest potential generic entry date is subject to various factors, including new patent filings and regulatory exclusivities[4].

Conclusion

Fluorodopa F-18 is a critical diagnostic tool for Parkinsonian Syndromes, offering enhanced accuracy in clinical diagnoses through PET imaging. The clinical trials have demonstrated its efficacy with no reported adverse reactions. The global fluorine-18 market, driven by increasing demand for PET scans and expanding healthcare infrastructure, is poised for significant growth over the next decade.

Key Takeaways

• Clinical Efficacy: Fluorodopa F-18 has shown positive and negative percent agreements with clinical diagnostic standards in detecting PS.
• Market Growth: The global fluorine-18 market is projected to reach US$ 3 billion by 2030, growing at a CAGR of 7.4%.
• Regional Dominance: North America currently dominates the market, with Asia Pacific expected to grow rapidly.
• Regulatory Landscape: Fluorodopa F-18 is protected by FDA regulatory exclusivities but not by US patents.

FAQs

What is the primary use of Fluorodopa F-18?

Fluorodopa F-18 is used for the visual detection of certain nerve cells in adult patients with suspected Parkinsonian Syndromes (PS) through PET scans.

What were the key findings of the clinical trial for Fluorodopa F-18?

The clinical trial showed varying degrees of positive and negative agreement between PET image results and clinical diagnostic standards, with no adverse reactions reported.

What is the projected growth of the global fluorine-18 market?

The global fluorine-18 market is expected to grow from US$ 1.4 billion in 2020 to US$ 3 billion by 2030, with a CAGR of 7.4%.

Which region dominates the global fluorine-18 market?

North America currently dominates the global fluorine-18 market, followed by Europe.

What are the key drivers of the global fluorine-18 market?

The market is driven by the increasing prevalence of diseases, rising health awareness, and the growing demand for PET/CT scans, particularly in oncology.

Sources

1. FDA: Drug Trials Snapshots: FLUORODOPA F 18 - FDA
2. Transparency Market Research: Fluorine-18 Market Insight and Trends 2031
3. SNMMI: Fluorodopa F-18 - SNMMI
4. DrugPatentWatch: FLUORODOPA F18 Drug Patent Profile
5. BioSpace: Fluorine-18 Market Size Worth Around US$ 3 Billion by 2030