Ultralow Dose PET Imaging for PSMA Expression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Piflufolastat F18.
- Who it may be relevant to
- Registry conditions: Healthy Volunteer, Prostate CA. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression
Overview
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.
Interventions
- Drug Piflufolastat F18
Participants will be injected with Piflufolastat F18 and imaged for up to 3 hours on a PET scanner
Primary outcome measures
- Signal-to-Noise Ratio (SNR) [Time frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
- Contrast-to-Noise Ratio (CNR) [Time frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
- Coefficient of Variation (COV) [Time frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
- 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.]
- Target-to-Background Ratio (TBR) [Time frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
- Qualitative Image Quality Score (Likert Scale) [Time frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
- Inter-reader Agreement (Weighted Kappa Statistics) [Time frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Nuclear Imaging Institute — Englewood
Identifiers
NCT: NCT06904313 · NII-0001-PSMA