Healthy VolunteerPhase 2NCT07284563
Ultralow Dose PET Imaging for 18F-NaF Uptake
A Phase 2 study testing 18F-NaF in people with Healthy Volunteer and Bone Alteration, run by Akiva Mintz at 2 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate an investigational ultralow dose positron emission tomography (PET imaging) technique for increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone detection and monitoring. 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, Bone Alteration, Bone and Joint Cancer
- What is being tested?
- 18F-NaF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Sep 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 millisievert [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 treatments that may interfere with radiotracer uptake as determined by the Principle Investigator.
- 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Nuclear Imaging Institute
Englewood, New Jersey, 07631
Barbara Blanchfield, 973-255-4955
- Enrolling by invitation
Nuclear Imaging Institute
Englewood, New Jersey, 07631
About this study
Official title: Evaluation of Ultralow Dose PET Imaging for Detecting 18F-NaF Uptake
The goal of this clinical trial is to evaluate an investigational ultralow dose positron emission tomography (PET imaging) technique for increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone 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 Fluorine-18 (18F)-sodium fluoride (NaF) 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 increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone 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-NaF, is FDA-approved for detecting prostate cancer at standard doses.
18F-NaF is often found to be taken up at higher levels in increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone. 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 increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone.
Investigators will enroll individuals with and without increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone to evaluate how ultralow dose PET imaging detects 18F-NaF uptake in different type of tissue.
Approximately 200 people will be enrolled in this study at the Nuclear Imaging Institute.
- Conditions
- Healthy Volunteer, Bone Alteration, Bone and Joint Cancer, Bone and Joint Infection, Arthritis
- Being tested
- 18F-NaF
- Keywords
- PET, PET/CT, low dose, nuclear imaging, sodium fluoride, bone
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-NaFDrug
Also called CT scan, PET scan, blood collection
Participants will be injected with 18F-NaF and imaged for up to 3 hours on a PET scanner
| Study group | Role | What they receive |
|---|---|---|
| ultralow dose 18F-NaF imaging group | Other | Participants 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: 18F-NaF |
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 posted16 Dec 2025
- Study start1 Sep 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-NaF imaging using a long axial field-of-view (LAFOV) PET scanner. The study aims to determine whether normal and diseased tissue 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 increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone. The inclusion of both healthy and diseased subjects allows for a comprehensive evaluation of normal organ uptake patterns, which is the primary objective of the study. Participants will undergo a single PET scan session per an enrollment, and be eligible for re-enrollment after 6 m
- 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
- NCT07284563
- Sponsor's protocol ID
- NII-0003-NaF
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 16 Dec 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultralow Dose PET Imaging for Detecting 18F-NaF Uptake
- ClinicalTrials.gov ID
- NCT07284563
- Acronym / sponsor ID
- NII-0003-NaF
- Conditions
- Healthy Volunteer, Bone Alteration, Bone and Joint Cancer, Bone and Joint Infection, Arthritis
- Keywords
- PET, PET/CT, low dose, nuclear imaging, sodium fluoride, bone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Akiva MintzUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 16 Dec 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 positron emission tomography (PET imaging) technique for increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone 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 Fluorine-18 (18F)-sodium fluoride (NaF) 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 increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone 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-NaF, is FDA-approved for detecting prostate cancer at standard doses.
18F-NaF is often found to be taken up at higher levels in increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone. 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 increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone.
Investigators will enroll individuals with and without increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone to evaluate how ultralow dose PET imaging detects 18F-NaF uptake 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-NaF imaging using a long axial field-of-view (LAFOV) PET scanner. The study aims to determine whether normal and diseased tissue 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 increased bone turnover that is found in diseases such as cancer, trauma, infection, arthritis, and other benign diseases of bone. The inclusion of both healthy and diseased subjects allows for a comprehensive evaluation of normal organ uptake patterns, which is the primary objective of the study. Participants will undergo a single PET scan session per an enrollment, and be eligible for re-enrollment after 6 m
| Arm | Type | Receives |
|---|---|---|
| ultralow dose 18F-NaF imaging group | Other | Drug: 18F-NaFParticipants 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 (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Participants who have exceeded NRC regulation for annual radiation exposure from prior research-related scans, including this study (50 millisievert [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 treatments that may interfere with radiotracer uptake as determined by the Principle Investigator.
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 |
|---|---|---|
| 18F-NaFAlso: CT scan, PET scan, blood collectionParticipants will be injected with 18F-NaF and imaged for up to 3 hours on a PET scanner | Drug | ultralow dose 18F-NaF 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 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-NaF in people with Healthy Volunteer and Bone Alteration, run by Akiva Mintz at 2 sites 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 3 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 (973-255-4955, 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 16 Dec 2025.