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Ultralow Dose PET Imaging for PSMA Expression

RecruitingPhase 2Ages 18 Years - 120 YearsAllAkiva Mintz
NCT06904313 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Piflufolastat F18
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Where

1 site
Nuclear Imaging Institute
Englewood, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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