NCT07542158 FLUORODOPA F-18 Parkinsonian Disorders Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07542158 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 13 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07542158 is a hot trial to watch
Parkinsonian Disorders is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07542158 is notable because it evaluates FLUORODOPA F-18 in a Phase 2 design sponsored by Nuclear Energy Institute. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07542158 |
| Official title | Ultralow Dose PET Imaging of 18F-FDOPA |
| Phase / status | Phase 2 / Enrolling by invitation |
| Intervention | FLUORODOPA F-18 |
| Sponsor | Nuclear Energy Institute |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Signal-to-Noise Ratio (SNR) |
| Endpoint time frame | Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years). |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for Parkinsonian syndromes, neuroendocrine tumors, and gliomas detection and monitoring. The main question it aims to answer is: Can the investigators optimize the timing, scan duration, and image reconstruction to reduce the radiation dose 10-100 fold of the current clinical standard? Participants will be injected with a radioactive tracer called 18F-FDOPA and be imaged on a new type of high sensitivity PET scanner for up to 3 hours.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Signal-to-Noise Ratio (SNR) (Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).) — Measurement of signal-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: SNR (unitless, numeric ratio)
- Contrast-to-Noise Ratio (CNR) (Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).) — Measurement of contrast-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: CNR (unitless, numeric ratio)
- Coefficient of Variation (COV) (Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).) — Measurement of the coefficient of variation in selected regions for evaluating image consistency across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Percentage (%)
- Spatial Resolution (Full Width at Half Maximum - FWHM) (Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).) — Assessment of spatial resolution using full width at half maximum (FWHM) across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Millimeters (mm)
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: FLUORODOPA F-18 is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: Nuclear Energy Institute is resolved to a normalized organization record in WASHINGTON COUNTY, United States. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07542158 provides a focused lens on Parkinsonian Disorders development. Its value will be determined by whether FLUORODOPA F-18 can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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