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Enrolling by Invitation

NCT Number: NCT07542158

Ultralow Dose PET Imaging of 18F-FDOPA

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.

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Key information

Conditions

Heathy Volunteer Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Glioma Gliomas Movement Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Neuroectodermal Tumors Neuroendocrine (NE) Tumors Parkinsonian Disorders Parkinsonian Syndromes

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nuclear Imaging Institute

Englewood, New Jersey, 07631, United States

About this study

This research study aims to evaluate an investigational ultralow dose PET imaging technique for Parkinsonian syndromes, neuroendocrine tumors, and gliomas detection and monitoring. "Investigational" means that the procedure or drug being studied is not yet approved by the FDA for the specific use being tested in this research. The PET imaging technique used in this study is considered investigational because it is being tested at an ultralow radiation dose that has not yet been approved for clinical use. The radiotracer, 18F-FDOPA, is FDA-approved for detecting prostate cancer at standard doses.

18F-FDOPA is often found to be taken up at higher levels in Parkinsonian syndromes, neuroendocrine tumors, and gliomas. In this study, investigators will use a very small amount of this tracer (less than 1/20th of the standard dose) along with advanced PET imaging technology to see if it is possible to create clear images while using much less radiation. This study aims to develop a safer imaging technique that could potentially be used more frequently for screening and monitoring Parkinsonian syndromes, neuroendocrine tumors, and gliomas.

Investigators will enroll individuals with and without Parkinsonian syndromes, neuroendocrine tumors, and gliomas to evaluate how ultralow dose PET imaging detects 18F-FDOPA uptake in different type of tissue.

Approximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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
  • medication & prior treatment exclusions
  • 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.

Treatment and study plan

18F-FDOPA

Drug

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

Other names: CT scan, PET scan, blood collection

Primary outcomes

  1. 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).

    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)

  2. Contrast-to-Noise Ratio (CNR)

    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).

    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)

  3. Coefficient of Variation (COV)

    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).

    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 (%)

  4. Spatial Resolution (Full Width at Half Maximum - FWHM)

    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).

    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)

  5. Target-to-Background Ratio (TBR)

    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).

    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)

  6. Qualitative Image Quality Score (Likert Scale)

    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).

    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)

  7. Inter-reader Agreement (Weighted Kappa Statistics)

    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).

    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)

Sponsors and collaborators

Lead sponsor

Akiva Mintz

Other

Registry information

Official study title

Evaluation of Ultralow Dose PET Imaging for Detecting 18F-FDOPA Uptake

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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