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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-NaF | Drug | Participants will be injected with 18F-NaF and imaged for up to 3 hours on a PET scanner |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Blanchfield | Contact | 973-255-4955 | bblanchfield@nii.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuclear Imaging Institute | Recruiting | Englewood | New Jersey | 07631 | United States |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013048 | Specimen Handling |
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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
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| 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. |
| Nuclear Imaging Institute | Enrolling by invitation | Englewood | New Jersey | 07631 | United States |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |