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NCT07284576

Ultralow Dose PET Imaging of 18F-flurpiridaz

Enrolling by Invitation
PHASE2Ages 18+InterventionalDiagnostic
Akiva Mintz
~200 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:18F-flurpiridaz

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Signal-to-Noise Ratio (SNR)
Measured over Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
+6 more outcomes measured

Conditions

Healthy Volunteer
Coronary Arterial Disease
Myocardial Ischemia
Myocardial Infarction

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Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Participants who have exceeded NRC 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 PSMA-targeted therapy (e.g., lutetium-177).
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 this trial measures

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

    Measurement of signal-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions.

  • Contrast-to-Noise Ratio (CNR)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    Measurement of contrast-to-noise ratio for image quality assessment across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: CNR (unitless, numeric ratio)

  • Coefficient of Variation (COV)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    Measurement of the coefficient of variation in selected regions for evaluating image consistency across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Percentage (%)

  • Spatial Resolution (Full Width at Half Maximum - FWHM)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    Assessment of spatial resolution using full width at half maximum (FWHM) across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Millimeters (mm)

  • Target-to-Background Ratio (TBR)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    Assessment of target-to-background ratio for evaluating PSMA-expressing tissue contrast across different scan durations, reconstruction techniques, and AI-enhanced image reconstructions. Unit of Measure: Ratio (unitless numeric ratio)

  • Qualitative Image Quality Score (Likert Scale)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    Independent qualitative evaluation of overall image quality, lesion detectability, image noise, and artifacts by nuclear medicine physicians, assessed using a 5-point Likert scale. Unit of Measure: Score on Likert Scale (1-5; 1 = worst, 5 = best)

  • Inter-reader Agreement (Weighted Kappa Statistics)Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

    Measurement of agreement among readers evaluating qualitative image quality scores, analyzed using weighted kappa statistics. Unit of Measure: Weighted kappa statistic (numeric value ranging from 0 to 1, 0 = no agreement, 1 = perfect agreement)