Recruiting
Phase 2

18F-DCFPyL

Sponsor:

Akiva Mintz

Code:

NCT06904313

Conditions

Healthy Volunteer

Prostate CA

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Piflufolastat F18

Study Details

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

Conditions

Healthy Volunteer

Prostate CA

Study ID

NCT06904313

Start date

May 12, 2025

Status verified date

Mar, 2025

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: ultralow dose PSMA imaging group

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

Interventions

Piflufolastat F18

Participants will be injected with Piflufolastat F18 and imaged for up to 3 hours on a PET scanner

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Barbara Blanchfield

9732554955bblanchfield@nii.org

Locations

Nuclear Imaging Institute

Recruiting

Englewood, New Jersey, United States, 07631

Contacts

Barbara Blanchfield

9732554955bblanchfield@nii.org

More Information

Sponsor

Akiva Mintz

Last update posted

Jun 4, 2025

Last verified

Mar, 2025

Keywords

  • PET scan
  • prostate cancer
  • psma
  • nuclear imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Akiva Mintz on 2025-06-04.