Healthy VolunteerPhase 2NCT06904313
Ultralow Dose PET Imaging for PSMA Expression
A Phase 2 study testing Piflufolastat F18 in people with Healthy Volunteer and Prostate CA, run by Akiva Mintz at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Prostate CA
- What is being tested?
- Piflufolastat F18
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2025to 30 Jun 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nuclear Imaging Institute
Englewood, New Jersey, 07631
Barbara Blanchfield, 9732554955, bblanchfield@nii.org
About this study
Official title: Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression
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
Read the 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
- Being tested
- Piflufolastat F18
- Keywords
- PET scan, prostate cancer, psma, nuclear imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piflufolastat F18Drug
Also called CT scan, PET scan, blood collection
Participants will be injected with Piflufolastat F18 and imaged for up to 3 hours on a PET scanner
| Study group | Role | What they receive |
|---|---|---|
| ultralow dose PSMA imaging group | Other | 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 Receives: Drug: Piflufolastat F18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal-to-Noise Ratio (SNR)
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)
Measured: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Contrast-to-Noise Ratio (CNR)
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)
Measured: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Coefficient of Variation (COV)
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 (%)
Measured: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Spatial Resolution (Full Width at Half Maximum - FWHM)
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)
Measured: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Target-to-Background Ratio (TBR)
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)
Measured: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Qualitative Image Quality Score (Likert Scale)
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)
Measured: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Inter-reader Agreement (Weighted Kappa Statistics)
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)
Measured: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start12 May 2025
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akiva Mintz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Akiva Mintz, Nuclear Imaging Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904313
- Sponsor's protocol ID
- NII-0001-PSMA
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultralow Dose PET Imaging for Detecting PSMA Expression
- ClinicalTrials.gov ID
- NCT06904313
- Acronym / sponsor ID
- NII-0001-PSMA
- Conditions
- Healthy Volunteer, Prostate CA
- Keywords
- PET scan, prostate cancer, psma, nuclear imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Akiva MintzUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| ultralow dose PSMA imaging group | Other | Drug: Piflufolastat F18Healthy 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 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Ability to provide informed consent and comply with study procedures.
- For female participants:
Key exclusion criteria (8 listed)
- 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
- Pregnant or breastfeeding individuals (negative pregnancy test required)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piflufolastat F18Also: CT scan, PET scan, blood collectionParticipants will be injected with Piflufolastat F18 and imaged for up to 3 hours on a PET scanner | Drug | ultralow dose PSMA imaging group |
Primary outcome
Signal-to-Noise Ratio (SNR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Volunteer
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Piflufolastat F18 in people with Healthy Volunteer and Prostate CA, run by Akiva Mintz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Blanchfield (9732554955, bblanchfield@nii.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.