Ultralow Dose PET Imaging for PSMA Expression

Phase 2

Not yet recruiting

• Conditions: Healthy Volunteer; Prostate CA
• Interventions: Drug: Piflufolastat F18

• Registration Number: NCT06904313
• Lead Sponsor: Nuclear Imaging Institute

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Study Start: 2025-05-01
• Primary Completion: 2030-04-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age ≥18 years.

2. Ability to provide informed consent and comply with study procedures.

3. For female participants:

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

Exclusion Criteria

1. Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 mSv total).

2. More than four prior enrollments in this study.

3. Participants with severe claustrophobia, chronic pain, or musculoskeletal conditions that prevent completion of the PET scan

4. Medication & Prior Treatment Exclusions

   • Concurrent PSMA-targeted therapy (e.g., lutetium-177).

5. Pregnant or breastfeeding individuals (negative pregnancy test required)

6. Inability to provide informed consent

7. Any condition that, in the investigator's judgment, may compromise participant safety or study integrity.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ultralow dose PSMA imaging group	Piflufolastat F18	Healthy subjects and cancer patients will be enrolled for an ultralow dose PET scan to evaluate image quality and optimize timing and reconstruction after reducing radiation doses 10-100 fold. Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Nuclear Imaging Institute; 🇺🇸 Englewood, New Jersey, United States