Ultralow Dose PET Imaging for PSMA Expression
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-120
SponsorAkiva Mintz
About this trial
The goal of this clinical trial is to evaluate an investigational ultralow dose PET imaging technique for prostate cancer 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-DCFPyL and be imaged on a new type of high sensitivity PET scanner for up to 3 hours
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years.
Ability to provide informed consent and comply with study procedures.
Must not be pregnant or breastfeeding.
Negative pregnancy test required for women of childbearing potential.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Piflufolastat F18
DrugParticipants will be injected with Piflufolastat F18 and imaged for up to 3 hours on a PET scanner
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: ultralow dose PSMA imaging groupOther 1 intervention
Trial outcomes
Primary outcomes
1
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. Unit of Measure: SNR (unitless, numeric ratio)
Time frame
Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.2
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. Unit of Measure: CNR (unitless, numeric ratio)
Time frame
Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.3
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. Unit of Measure: Percentage (%)
Time frame
Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.4
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. Unit of Measure: Millimeters (mm)
Time frame
Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Akiva Mintz
Lead sponsor
Nuclear Imaging Institute
Sponsor institution
Source ClinicalTrials.gov