Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-09-01
2030-06-30
Brief Summary
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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
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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
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Study Design
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NA
SINGLE_GROUP
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
DIAGNOSTIC
NONE
Study Groups
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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
18F-NaF
Participants will be injected with 18F-NaF and imaged for up to 3 hours on a PET scanner
Interventions
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18F-NaF
Participants will be injected with 18F-NaF and imaged for up to 3 hours on a PET scanner
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
120 Years
ALL
Yes
Sponsors
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Akiva Mintz
OTHER
Responsible Party
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Akiva Mintz
Executive Director
Locations
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Nuclear Imaging Institute
Englewood, New Jersey, United States
Nuclear Imaging Institute
Englewood, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Barbara Blanchfield
Role: primary
Other Identifiers
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NII-0003-NaF
Identifier Type: -
Identifier Source: org_study_id