Ultralow Dose PET Imaging for 18F-NaF Uptake

NCT07284563 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: NII-0003-NaF
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (7)

• 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)

  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)

  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 (%)

  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)

  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)

  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)

  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)

  Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period.

Study Arms (1)

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

Drug: 18F-NaF

Interventions

18F-NaF DRUG

Participants will be injected with 18F-NaF and imaged for up to 3 hours on a PET scanner

Also known as: CT scan, PET scan, blood collection

ultralow dose 18F-NaF imaging group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Akiva Mintz: lead

Study Sites (2)

Nuclear Imaging Institute

Englewood, New Jersey, 07631, United States

RECRUITING

Nuclear Imaging Institute

Englewood, New Jersey, 07631, United States

ENROLLING BY INVITATION

MeSH Terms

Conditions

Arthritis

Interventions

Magnetic Resonance Spectroscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Central Study Contacts

Barbara Blanchfield

CONTACT

973-255-4955; bblanchfield@nii.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director

Model Details: 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

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (2)