Recruiting
Phase 2

Fluorine-18

Sponsor:

Akiva Mintz

Code:

NCT07284563

Conditions

Healthy Volunteer

Bone Alteration

Bone and Joint Cancer

Bone and Joint Infection

Arthritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

18F-NaF

Study Details

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

Study ID

NCT07284563

Start date

Sep 1, 2025

Status verified date

Dec, 2025

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: ultralow dose 18F-NaF imaging group

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

Interventions

18F-NaF

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

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. ]
  • Contrast-to-Noise Ratio (CNR) [ Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. ]
  • Coefficient of Variation (COV) [ Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. ]
  • 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. ]
  • Target-to-Background Ratio (TBR) [ Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. ]
  • Qualitative Image Quality Score (Likert Scale) [ Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. ]
  • Inter-reader Agreement (Weighted Kappa Statistics) [ Time Frame: Evaluated annually (once per year), based on pooled images acquired during the preceding 12-month period. ]

Central Contacts and Locations

Central contacts

Barbara Blanchfield

973-255-4955bblanchfield@nii.org

Locations

Nuclear Imaging Institute

Recruiting

Englewood, New Jersey, United States, 07631

Contacts

Barbara Blanchfield

973-255-4955

More Information

Sponsor

Akiva Mintz

Last update posted

Dec 16, 2025

Last verified

Dec, 2025

Keywords

  • PET
  • PET/CT
  • low dose
  • nuclear imaging
  • sodium fluoride
  • bone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Akiva Mintz on 2025-12-16.