Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06904313

Ultralow Dose PET Imaging for PSMA Expression

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Healthy Volunteer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate CA Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

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

Location status: Recruiting

Location contact

Barbara Blanchfield

CONTACT

[email protected]

9732554955

About this study

This research study aims to evaluate an investigational ultralow dose PET imaging technique for prostate cancer 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-DCFPyL, is FDA-approved for detecting prostate cancer at standard doses.

18F-DCFPyL attaches to a protein called PSMA, which is often found at higher levels on certain cancer cells, such as prostate cancer cells. 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 prostate cancer.

Investigators will enroll individuals with and without prostate cancer to evaluate how ultralow dose PET imaging detects PSMA 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 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.

Treatment and study plan

Piflufolastat F18

Drug

Participants will be injected with Piflufolastat F18 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: 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)

  2. Contrast-to-Noise Ratio (CNR)

    Time frame: 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)

  3. Coefficient of Variation (COV)

    Time frame: 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 (%)

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

    Time frame: 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)

  5. Target-to-Background Ratio (TBR)

    Time frame: 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)

  6. Qualitative Image Quality Score (Likert Scale)

    Time frame: 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)

  7. Inter-reader Agreement (Weighted Kappa Statistics)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Blanchfield

CONTACT

[email protected]

9732554955

Sponsors and collaborators

Lead sponsor

Akiva Mintz

Other

Registry information

Official study title

Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Apr 1, 2025
Registry last updated
Jun 4, 2025

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.