Clinical trial NCT06904313: Ultralow Dose PET Imaging for PSMA Expression
Official title: Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Healthy Volunteer
Prostate CA
Keywords: PET scan
prostate cancer
psma
nuclear imaging
Lead sponsor: Nuclear Imaging Institute
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, open-label, single-center imaging study designed to evaluate the optimal timing and reconstruction parameters for ultralow dose 18F-DCFPyL PET imaging using a long axial field-of-view (LAFOV) PET scanner.

The study aims to determine whether PSMA-expressing tissues, including both normal and malignant lesions, can be accurately visualized at significantly lower radiotracer doses, while optimizing scan duration and reconstruction methods to maintain diagnostic performance.

A total of 200 participants will be enrolled in a single cohort, including healthy volunteers and individuals with suspected or confirmed PSMA-expressing malignancies. The inclusion of both healthy and diseased subjects allows for a comprehensive evaluation of normal organ uptake patterns, which is the primary objective. Participants will undergo a single PET scan session per an enrollment, and be eligible for re-enrollment after 6 months, for a maximum of 5 enrollments if they meet criteria.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Signal-to-Noise Ratio (SNR)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Contrast-to-Noise Ratio (CNR)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Coefficient of Variation (COV)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Spatial Resolution (Full Width at Half Maximum - FWHM)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Target-to-Background Ratio (TBR)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Qualitative Image Quality Score (Likert Scale)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
measure: Inter-reader Agreement (Weighted Kappa Statistics)
timeFrame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Nuclear Imaging Institute
state: New Jersey
Study officials:
References: