Clinical trial · Interventional
Ultralow Dose PET Imaging of 18F-FDOPA
Evaluation of Ultralow Dose PET Imaging for Detecting 18F-FDOPA Uptake
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gliomas | Glioma | ALIAS | 0.90 |
| Heathy Volunteer | — | UNRESOLVED | — |
| Neuroendocrine (NE) Tumors | — | UNRESOLVED | — |
| Parkinsonian Syndromes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDOPA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ultralow dose 18F-FDOPA imaging group
- description
- Participants will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours
- interventionNames
- Drug: 18F-FDOPA
Primary outcomes (7)
- measure
- Signal-to-Noise Ratio (SNR)
- timeFrame
- Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).
- description
- 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)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: 1. age ≥18 years. 2. ability to provide informed consent and comply with study procedures. 3. for female participants: * must not be pregnant or breastfeeding. * negative pregnancy test required for women of childbearing potential. Exclusion criteria: 1. participants who have exceeded Nuclear Regulatory Commission regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total). 2. more than four prior enrollments in this study. 3. participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the pet scan 4. medication \& prior treatment exclusions • concurrent treatments that may interfere with radiotracer uptake as determined by the Principal Investigator. 5. pregnant or breastfeeding individuals (negative pregnancy test required) 6. inability to provide informed consent 7. any condition that, in the investigator's judgment, may compromise participant safety or study integrity.
References
Publications (0)
Data not yet available