Ultralow Dose PET Imaging for PSMA Expression

Part of paid clinical trials in Englewood, New Jersey.

Sponsor
Akiva Mintz
Study ID
NCT06904313
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Volunteer
  • Prostate CA

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
May 12, 2025
Status verified
Mar 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: ultralow dose PSMA imaging group
    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

Primary Outcome Measure

Signal-to-Noise Ratio (SNR) [ Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nuclear Imaging InstituteEnglewoodNew Jersey07631
Barbara Blanchfield
[email protected]
9732554955

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By research site
Nuclear Imaging Institute· Englewood, NJ

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