Status:

RECRUITING

Ultralow Dose PET Imaging for PSMA Expression

Lead Sponsor:

Akiva Mintz

Conditions:

Healthy Volunteer

Prostate CA

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief 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 inv...

Detailed Description

This research study aims to evaluate an investigational ultralow dose PET imaging technique for prostate cancer detection and monitoring. "Investigational" means that the procedure or drug being studi...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

May 12 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2030

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06904313

Start Date

May 12 2025

End Date

June 30 2030

Last Update

June 4 2025

Active Locations (1)

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1

Nuclear Imaging Institute

Englewood, New Jersey, United States, 07631