Ultralow Dose PET Imaging for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Nuclear Imaging Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Research Team

Eligibility Criteria

This trial is for healthy individuals and those with prostate cancer. It's designed to test a new low-radiation PET scan technique using an injected tracer. The goal is to see if they can get clear images with much less radiation than usual.

Inclusion Criteria

Ability to provide informed consent and comply with study procedures

For female participants: Must not be pregnant or breastfeeding, Negative pregnancy test required for women of childbearing potential

I am 18 years old or older.

Exclusion Criteria

Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total)

Pregnant or breastfeeding individuals (negative pregnancy test required)

Inability to provide informed consent

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Treatment Details

Interventions

Piflufolastat F18 (Cancer Imaging Agent)

Trial OverviewThe study tests the use of Piflufolastat F18, a radioactive tracer, in ultralow dose PET scans for detecting and monitoring prostate cancer. Researchers want to find out if lower doses can still provide high-quality images by optimizing scan timing and image processing.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ultralow dose PSMA imaging groupExperimental Treatment1 Intervention

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