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.
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.
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
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
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Fluorodopa F18: Clinical Trials, Market Analysis, and Projections
Last updated: February 6, 2026
What are the recent developments in clinical trials for Fluorodopa F18?
Fluorodopa F18 (FDOPA F18) continues to undergo evaluation primarily for neurodegenerative disease diagnostics, especially Parkinson’s disease and other movement disorders. Recent updates include:
Phase III Trials: Several ongoing Phase III trials target Parkinsonian syndromes. These evaluate diagnostic accuracy, safety, and comparative efficacy with existing imaging agents.
Approved Uses: In 2016, the FDA approved FDOPA F18 with a pre-specified imaging purpose, expanding clinical adoption.
Recent Regulatory Actions: The European Medicines Agency (EMA) approved the drug in 2012 under the CE mark, with continued post-marketing studies ongoing to address long-term safety.
Emerging Trials: Smaller, investigator-led studies explore FDOPA F18’s utility in detecting early neurodegeneration and differentiating Parkinson’s disease from atypical parkinsonian syndromes.
How does the current market landscape look for FDOPA F18?
The market for FDOPA F18 is tightly coupled with the neuroimaging diagnostics space, particularly positron emission tomography (PET).
Market Segment
Size (2022)
Key Players
Regulatory Status
Notes
Diagnostic Imaging for Parkinson’s
~$1.0 billion
GE Healthcare, Siemens, Jubilant DraxImage
Widely approved in North America, Europe
Growth driven by rising neurodegenerative disorder prevalence.
PET Radiotracers
$2.7 billion
18F-based agents dominate
Regulation varies; some agents off-patent
FDOPA F18 is among the top used for brain imaging.
Market Drivers: Growing aging population with Parkinson’s disease (PD), increased awareness of early diagnosis benefits.
Competitive Landscape: FDOPA F18 faces competition from other PET tracers like FDG, FBB, and newer agents targeting beta-amyloid and tau.
What are the projections for FDOPA F18 in the next five years?
Market analysts project steady growth, with several factors influencing future dynamics:
Compound Annual Growth Rate (CAGR): The neuroimaging tracers segment is expected to grow at 7-9% CAGR through 2027.
Market Share Forecast: FDOPA F18 is expected to maintain a leading position in neurodegenerative diagnostics, capturing approximately 35-40% of PET radiotracer sales dedicated to neurological applications within five years.
Regulatory Trends: Increasing acceptance of FDOPA F18 for early-stage diagnosis could expand its off-label applications.
Technological Advancements: Improvements in PET scanner resolution and data integration may enhance diagnostic confidence, pushing utilization upward.
What challenges could impact further adoption?
Regulatory Variability: Approval and reimbursement policies differ across regions, influencing market penetration.
Availability Constraints: FDOPA F18 has a short half-life (~110 minutes), requiring proximity to cyclotron facilities, limiting distribution.
Cost Factors: PET scans involving FDOPA F18 are expensive, potentially limiting use in low-resource settings.
Emerging Alternatives: Newer tracers and imaging modalities may replace FDOPA F18 if they demonstrate superior efficacy or cost advantages.
Key Takeaways
FDOPA F18 remains a vital diagnostic agent in neurodegenerative disease imaging with ongoing clinical evaluation focusing on early detection.
The market size is poised for consistent growth, driven by aging populations and technological improvements.
Regulatory landscapes and logistical challenges could limit broader adoption, but innovations in radiochemistry and imaging may mitigate these issues.
Competition from other PET tracers and imaging modalities influences market share and future growth potential.
FAQs
What is the primary clinical use of FDOPA F18?
It primarily detects dopamine synthesis capacity, aiding in Parkinson’s disease diagnosis.
Are there any approved alternative tracers?
Yes, tracers like F-18 dopamine transporter (DAT) agents and novel PET tracers are in development or approved, offering alternative imaging options.
Is FDOPA F18 available globally?
Its availability varies; regions with access to cyclotron facilities and established nuclear medicine infrastructure have higher access.
What is the regulatory outlook for FDOPA F18?
Regulatory approval is well-established in North America and Europe, with ongoing post-marketing studies to expand indications.
How does the cost of FDOPA F18 scans compare to other neuroimaging tests?
PET scans with FDOPA F18 are costly, typically ranging from $2,000 to $4,000 per scan, limiting their use primarily to specialized centers.
Citations
[1] Market data and projections sourced from GlobalData, 2022.
[2] Regulatory updates from FDA and EMA records, 2022.
[3] Clinical trial registry and recent publications, 2022.
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