RecruitingPhase 2NCT06904313

Ultralow Dose PET Imaging for PSMA Expression

Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression


Sponsor

Akiva Mintz

Enrollment

200 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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.

Interventions

DRUGPiflufolastat F18

Participants will be injected with Piflufolastat F18 and imaged for up to 3 hours on a PET scanner


Locations(1)

Nuclear Imaging Institute

Englewood, New Jersey, United States

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NCT06904313


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