Last Updated: June 18, 2026

CLINICAL TRIALS PROFILE FOR FLUORODOPA F18


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All Clinical Trials for FLUORODOPA F18

Trial ID Title Status Sponsor Phase Start Date Summary
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.
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
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for FLUORODOPA F18

Condition Name

Condition Name for FLUORODOPA F18
Intervention Trials
Malignant Glioma 4
Glioblastoma 3
Adult Anaplastic Oligodendroglioma 2
Adult Pineal Gland Astrocytoma 2
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Condition MeSH

Condition MeSH for FLUORODOPA F18
Intervention Trials
Glioma 7
Glioblastoma 5
Astrocytoma 2
Oligodendroglioma 2
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Clinical Trial Locations for FLUORODOPA F18

Trials by Country

Trials by Country for FLUORODOPA F18
Location Trials
United States 14
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Trials by US State

Trials by US State for FLUORODOPA F18
Location Trials
Minnesota 6
Pennsylvania 3
Texas 2
Arizona 1
Missouri 1
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Clinical Trial Progress for FLUORODOPA F18

Clinical Trial Phase

Clinical Trial Phase for FLUORODOPA F18
Clinical Trial Phase Trials
PHASE2 1
Phase 2 6
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for FLUORODOPA F18
Clinical Trial Phase Trials
Active, not recruiting 4
Terminated 3
Not yet recruiting 2
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Clinical Trial Sponsors for FLUORODOPA F18

Sponsor Name

Sponsor Name for FLUORODOPA F18
Sponsor Trials
Mayo Clinic 6
National Cancer Institute (NCI) 5
University of California, Los Angeles 1
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Sponsor Type

Sponsor Type for FLUORODOPA F18
Sponsor Trials
Other 16
NIH 5
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Fluorodopa F 18: Clinical Trials Update, Market Analysis, and Market Projection

Last updated: May 8, 2026

What is Fluorodopa F 18 and what indications drive demand?

Fluorodopa F 18 is a radiopharmaceutical used in PET imaging. In routine oncology and neuroimaging workflows, the commercial use case is dominated by neurology imaging for movement disorders, most notably Parkinson’s disease and related parkinsonian syndromes, where imaging helps assess dopaminergic function and support differential diagnosis and management.

Core market dynamics

  • Site-level consumables model: demand flows through PET center procedure volume and radiotracer availability rather than pharmacy retail.
  • Regulatory qualification and procurement cycles: hospitals buy via vendor contracts for isotope supply and labeling readiness.
  • Production and logistics bottlenecks: F-18 production capacity and distribution windows drive fill rates and service continuity.

What is the clinical trials landscape for Fluorodopa F 18?

A complete clinical-trials update requires a live registry pull (e.g., ClinicalTrials.gov and EU/other registries). The provided prompt does not include trial IDs, registry snapshots, or dates. Under those constraints, a complete and accurate trials update cannot be produced without fabricating data.

How does the commercial landscape work for Fluorodopa F 18?

Fluorodopa F 18 is sold in a manner consistent with radiopharmaceutical supply chains: it is ordered as a ready-to-use PET radiotracer for specific imaging protocols. Market outcomes depend on:

  • Radiochemical supply reliability (F-18 dose availability and batch release timing)
  • Local cyclotron and manufacturer footprint
  • Facility capability (PET/CT or PET/MRI workflow integration)
  • Protocol adoption in movement disorder imaging pathways

Typical buyer and decision unit

  • Hospital nuclear medicine departments and imaging centers
  • Radiology service lines that manage patient access and scheduling
  • Procurement focused on lead time, dose yield, and uptime

Key procurement constraints

  • Distribution windows and time-to-scan requirements
  • Dose labeling compliance for local use
  • Competitive tendering across radiopharmaceutical vendors

What is the market size baseline and what is the near-term outlook?

A defensible market size and projection require:

  • an explicit current market volume (e.g., number of doses/procedures, or annual revenue for fluorodopa),
  • geographic segmentation,
  • and credible forward assumptions (procedure growth, penetration, pricing, and capacity).

No numeric baseline, geographic scope, or cited market study inputs were included in the prompt. Producing market size and projection numbers without those inputs would require unsupported assumptions.

What drives growth in Fluorodopa F 18?

Even without numeric sizing, the growth drivers in this category are structurally specific:

  • Procedure growth tied to referral patterns
    • neurologist and movement-disorder clinic throughput influences imaging volume
  • Clinical pathway expansion
    • broader adoption of functional imaging as part of diagnostic and management planning
  • Capacity and service continuity
    • vendors that reliably supply doses capture procedure demand when competing supply is constrained
  • Technology adjacency
    • increased PET adoption in hospitals can indirectly lift access to PET-based tracers like fluorodopa

Where do risks show up in market forecasting?

Forecast risk is mainly operational and reimbursement-driven:

  • F-18 supply constraints
    • regional cyclotron capacity and isotope production outages affect availability
  • Protocol standardization changes
    • shifts in clinical guidelines can reallocate tracer demand across imaging modalities
  • Competitive supply
    • radiopharmaceutical tenders can reprice contracts rapidly
  • Regulatory and labeling variability
    • product availability can change with manufacturing and regulatory lifecycle events

What is the business case for R&D and investment decisions?

If you are evaluating commercial upside, the decisive factors are not abstract “market growth,” but measurable levers:

  • Contract win rates and service uptime
  • Supply agreement terms (dose allocation during constraints)
  • Geographic footprint
  • Regulatory file robustness for label claims and competitive positioning
  • Cost-to-serve (cycle-to-release and distribution footprint)

A rigorous projection model should map:

  • PET scanner installed base and throughput,
  • movement disorder patient incidence trends at the service footprint,
  • tracer eligibility and protocol adoption rates,
  • and vendor supply capability.

Key Takeaways

  • Fluorodopa F 18 demand is procedure-driven, tied to PET imaging access and movement disorder clinical workflows.
  • A complete clinical trials update cannot be produced from the information provided because it requires current registry data.
  • Market sizing and numeric projections also cannot be produced without an explicit baseline and cited market-study inputs; radiopharmaceutical markets require procedure-volume and pricing assumptions that were not provided.
  • The highest-impact forecast variables are F-18 supply continuity, PET center throughput, protocol adoption, and contract-driven pricing.

FAQs

  1. What imaging use case drives Fluorodopa F 18 demand?
    PET imaging for movement disorders, primarily dopaminergic function assessment used in clinical pathways for Parkinson’s disease and related conditions.

  2. Is Fluorodopa F 18 a retail drug market?
    No. Demand is generated through hospital and imaging-center procedures and supplier contracts tied to radiotracer supply and scheduling.

  3. What operational factor most affects availability?
    F-18 isotope production capacity and distribution timing, which govern dose availability and scan scheduling.

  4. What clinical factor changes tracer demand fastest?
    Changes in clinical pathway adoption, protocol standardization, and referral behavior that determine how often fluorodopa PET is used.

  5. What data is required for a reliable market projection?
    A baseline procedure volume (or dose volume) plus geographic segmentation, pricing/mix assumptions, and supply-capacity constraints to convert procedure growth into revenue.


References

  1. (No sources were provided in the prompt, and no live registry or market report inputs were included.)

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