Ultralow-dose PET imaging for PSMA expression in prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 2 protocol uses a high-sensitivity PET scanner and the FDA-approved tracer 18F-DCFPyL at much lower-than-standard activity to image PSMA expression. Investigators will optimize injection-to-scan timing, scan duration, and image reconstruction methods while imaging participants for up to three hours after tracer injection. The study enrolls roughly 200 adults, including healthy volunteers and people with prostate cancer, to compare detection in different tissue types. The goal is to determine whether clear diagnostic images can be produced with a 10–100× reduction in radiation dose compared with current clinical practice.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nuclear Imaging Institute
  Englewood, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Barbara Blanchfield
• Email: bblanchfield@nii.org
• Phone: 9732554955

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.