Ultralow-dose PET imaging for PSMA expression in prostate cancer
Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression
This test will try to see if an ultralow-dose PET scan using 18F-DCFPyL can detect PSMA in people with and without prostate cancer while cutting radiation exposure by 10- to 100-fold.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Nuclear Imaging Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Englewood, New Jersey) |
| Trial ID | NCT06904313 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 and older who can give informed consent and are willing to undergo multi-hour PET imaging, including healthy volunteers and people with prostate cancer who are not receiving concurrent PSMA-targeted therapy, are ideal candidates.
Not a fit: People who are pregnant or breastfeeding, exceed allowable cumulative research radiation exposure limits, cannot tolerate long scans due to claustrophobia or pain, or are on concurrent PSMA-targeted therapies are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could enable safer, lower-radiation PET scans that patients could undergo more frequently for detection and monitoring of prostate cancer.
How similar studies have performed: High-sensitivity and total-body PET work using PSMA tracers has shown promising pilot results at reduced doses, but achieving 10–100× radiation reductions with diagnostic image quality at this scale is still largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Englewood, New Jersey
- Nuclear Imaging Institute — Englewood, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Barbara Blanchfield
- Email: bblanchfield@nii.org
- Phone: 9732554955
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.