By InvitationPhase 2

Ultralow Dose PET Imaging of 18F-FDOPA

United States200 participantsStarted 2025-05-12

Plain-language 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.

Who can participate

Age range18 Years – 120 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. age ≥18 years.
✓. ability to provide informed consent and comply with study procedures.
✓. for female participants:

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
✕. 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.

What they're measuring

Signal-to-Noise Ratio (SNR)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

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

Trial details

NCT IDNCT07542158

SponsorAkiva Mintz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-06-30

View on ClinicalTrials.gov More Heathy Volunteer trials

Plain-language summary

Who can participate

Age range18 Years – 120 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. age ≥18 years.
✓. ability to provide informed consent and comply with study procedures.
✓. for female participants:

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
✕. 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.

What they're measuring

Signal-to-Noise Ratio (SNR)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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)

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