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Ultralow Dose PET Imaging for Bone Turnover

This study is testing a new way to use PET imaging with a very low dose of a radioactive tracer called 18F-NaF. The goal is to see if we can get clear images of bone changes (like those seen in cancer, infections, or arthritis) while using much less radiation than current methods. This could make imaging safer and potentially allow for more frequent monitoring. You might be able to join if you are 18 years or older and meet other health criteria. Success for this study means showing that this ultralow dose imaging can produce good quality images, measured by signal-to-noise ratio, contrast-to-noise ratio, and coefficient of variation. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 200 participants, including healthy volunteers and those with various bone conditions.
What's involved
Participants will receive an injection of 18F-NaF and be imaged on a PET scanner for up to 3 hours.
Compensation
Not stated in the trial record.
Follow-up
Image quality will be evaluated annually based on pooled images acquired during the preceding 12-month period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07284563

Ultralow Dose PET Imaging for 18F-NaF Uptake

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Akiva Mintz
~200 participants
Updated 2025-12-16 on ClinicalTrials.gov
What's tested:18F-NaF

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Signal-to-Noise Ratio (SNR)
Measured over Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.
+6 more outcomes measured

Conditions

Healthy Volunteer
Bone Alteration
Bone and Joint Cancer
Bone and Joint Infection
Arthritis

Explore related trials

ArthritisBone and Joint CancerBone and Joint InfectionHealthy VolunteerMolecular Genetic Variation

Where it's being run

2 sites across 1 states
New Jersey2

Who to contact

Barbara Blanchfield
[email protected]
973-255-4955
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Signal-to-Noise Ratio (SNR)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)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)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)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)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)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)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)