Ultralow Dose PET Imaging for PSMA Expression

NCT ID: NCT06904313

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-12
• Study Completion Date: 2030-06-30

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.

Conditions

Healthy Volunteer; Prostate CA

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Piflufolastat F18

Intervention Type: DRUG

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

Interventions

Piflufolastat F18

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

Intervention Type: DRUG

Other Intervention Names

CT scan; PET scan; blood collection

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Akiva Mintz

OTHER

Sponsor Role: lead

Responsible Party

Akiva Mintz

Executive Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Nuclear Imaging Institute

Englewood, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Barbara Blanchfield

Role: CONTACT

bblanchfield@nii.org

9732554955

Facility Contacts

Barbara Blanchfield

Role: primary

bblanchfield@nii.org

9732554955

Other Identifiers

NII-0001-PSMA

Identifier Type: -

Identifier Source: org_study_id