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Ultralow Dose PET Imaging for Prostate Cancer Detection

This study is testing a new way to detect prostate cancer using a special type of scan called a PET scan. You would receive a very small amount of a tracer called Piflufolastat F18, which helps highlight prostate cancer cells. The goal is to see if we can get clear images with much less radiation than current standard scans. Researchers want to find out if they can make the timing, scan duration, and image reconstruction better to significantly lower the radiation dose. This study is open to healthy volunteers and people with prostate cancer, aged 18 to 120. We are looking for about 200 participants. Success will be measured by how clear and consistent the images are.

Study design
This interventional study plans to enroll approximately 200 participants, including healthy volunteers and individuals with prostate cancer.
What's involved
Participants will be injected with Piflufolastat F18 and then undergo PET imaging for up to 3 hours.
Compensation
Not stated in the trial record.
Follow-up
Image quality will be evaluated annually based on pooled images acquired during the preceding 12-month period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06904313

Ultralow Dose PET Imaging for PSMA Expression

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Akiva Mintz
~200 participants
Updated 2025-06-04 on ClinicalTrials.gov
What's tested:Piflufolastat F18

At a glance

Recruiting sites
1 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
Prostate CA

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

Barbara Blanchfield
[email protected]
9732554955
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Must not be pregnant or breastfeeding.
Negative pregnancy test required for women of childbearing potential.

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. Unit of Measure: SNR (unitless, numeric ratio)

  • 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)