Ultralow Dose PET Imaging of 18F-FDOPA

Part of paid clinical trials in Englewood, New Jersey.

Sponsor
Akiva Mintz
Study ID
NCT07542158
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Gliomas
  • Heathy Volunteer
  • Neuroendocrine (NE) Tumors
  • Parkinsonian Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Accepted

Interventions

  • 18F-FDOPA — DRUG
    Participants will be injected with 18F-FDOPA 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 Parkinsonian syndromes, neuroendocrine tumors, and gliomas 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-FDOPA 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
Apr 2026
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 18F-FDOPA imaging group
    Participants 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: Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nuclear Imaging InstituteEnglewoodNew Jersey07631-

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By research site
Nuclear Imaging Institute· Englewood, NJ

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