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RecruitingAccepts healthy volunteersPhase 2

Ultralow Dose PET Imaging for PSMA Expression

Akiva Mintz · NCT06904313

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–120 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
200
US sites recruiting
1
Study start
May 12, 2025
Record last updated
June 4, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: Piflufolastat F18

Conditions: Healthy Volunteer; Prostate CA

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Age ≥18 years.
  • 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.

Exclusion Criteria

  • Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total).
  • More than four prior enrollments in this study.
  • Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan
  • Medication \& Prior Treatment Exclusions
  • Concurrent PSMA-targeted therapy (e.g., lutetium-177).
  • Pregnant or breastfeeding individuals (negative pregnancy test required)
  • Inability to provide informed consent
  • Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.

Recruiting US locations

  • Nuclear Imaging Institute

    Englewood, NJ 07631

    Site contact: Barbara Blanchfield · 9732554955 · bblanchfield@nii.org

Study contacts (from the official record)

  • Barbara Blanchfield · 9732554955 · bblanchfield@nii.org
All healthy volunteers studies in New Jersey →
Ultralow Dose PET Imaging for PSMA Expression (NCT06904313) | Bored Studies