Clinical trial · Interventional
Ultralow Dose PET Imaging for PSMA Expression
Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression
- 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 prostate cancer 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-DCFPyL and be imaged on a new type of high sensitivity PET scanner for up to 3 hours
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Volunteer | — | UNRESOLVED | — |
| Prostate CA | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Piflufolastat F18 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ultralow dose PSMA imaging group
- description
- Healthy subjects and cancer patients 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: Piflufolastat F18
Primary outcomes (7)
- measure
- Signal-to-Noise Ratio (SNR)
- timeFrame
- Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
- description
- Measurement of signal-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: SNR (unitless, numeric ratio)
- measure
- Contrast-to-Noise Ratio (CNR)
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 NRC 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 PSMA-targeted therapy (e.g., lutetium-177). 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)
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