Ultralow Dose PET Imaging of 18F-FDOPA

NCT07542158 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: NII-0004-FDOPA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Signal-to-Noise Ratio (SNR)

  Measurement of signal-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: SNR (unitless, numeric ratio)

  Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).

• Contrast-to-Noise Ratio (CNR)

  Measurement of contrast-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: CNR (unitless, numeric ratio)

  Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).

• Coefficient of Variation (COV)

  Measurement of the coefficient of variation in selected regions for evaluating image consistency across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Percentage (%)

  Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).

• Spatial Resolution (Full Width at Half Maximum - FWHM)

  Assessment of spatial resolution using full width at half maximum (FWHM) across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Millimeters (mm)

  Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).

• Target-to-Background Ratio (TBR)

  Assessment of target-to-background ratio for evaluating PSMA-expressing tissue contrast across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Ratio (unitless numeric ratio)

  Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).

• Qualitative Image Quality Score (Likert Scale)

  Independent qualitative evaluation of overall image quality, lesion detectability, image noise, and artifacts by nuclear medicine physicians, assessed using a 5-point Likert scale. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Score on Likert Scale (1-5; 1 = worst, 5 = best)

  Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).

• Inter-reader Agreement (Weighted Kappa Statistics)

  Measurement of agreement among readers evaluating qualitative image quality scores, analyzed using weighted kappa statistics. Each subject contributes a single imaging dataset acquired at the time of their scan (no longitudinal follow-up). Unit of Measure: Weighted kappa statistic (numeric value ranging from 0 to 1, 0 = no agreement, 1 = perfect agreement)

  Single timepoint (Day 1, imaging visit); aggregated analysis conducted annually using data from the prior 12 months, through study completion (up to 5 years).

Study Arms (1)

ultralow dose 18F-FDOPA imaging group

OTHER

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

Drug: 18F-FDOPA

Interventions

18F-FDOPA DRUG

Participants will be injected with 18F-FDOPA and imaged for up to 3 hours on a PET scanner

Also known as: CT scan, PET scan, blood collection

ultralow dose 18F-FDOPA imaging group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• participants who have exceeded Nuclear Regulatory Commission 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
• concurrent treatments that may interfere with radiotracer uptake as determined by the Principal Investigator.
• 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.

Sponsors & Collaborators

• Akiva Mintz: lead

Study Sites (1)

Nuclear Imaging Institute

Englewood, New Jersey, 07631, United States

Location

MeSH Terms

Conditions

Parkinsonian Disorders; Neoplasms; Glioma

Interventions

fluorodopa F 18; Magnetic Resonance Spectroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 21, 2026
• Study Start: May 12, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)