Ultralow Dose PET Imaging for Bone Conditions
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new, low-radiation PET imaging method to better detect and monitor bone conditions. It examines the effectiveness of this technique for diseases like cancer, arthritis, and bone infections. Participants receive a tiny amount of a special tracer (18F-NaF) to help create images of their bones. The trial suits those with bone conditions who can remain in a PET scanner for up to three hours. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in bone imaging technology.
What prior data suggests that this PET imaging technique is safe for bone conditions?
Earlier studies have safely used 18F-NaF, a type of radioactive substance, for PET scans. Research shows it can detect bone problems, such as cancer or infections, by highlighting affected areas. It is a common tool in medical imaging.
Studies suggest that a lower dose of 18F-NaF can still provide clear images while reducing radiation exposure, thus lowering risk for patients undergoing the scan.
Patients have tolerated 18F-NaF well, with no major reports of serious side effects, making it a promising option for those concerned about radiation.12345Why are researchers excited about this trial?
Researchers are excited about ultralow dose 18F-NaF PET imaging because it offers a new way to assess bone conditions with significantly reduced radiation exposure. Traditionally, bone imaging techniques like standard PET scans involve higher radiation doses, but this method reduces those doses by 10-100 times, making it safer for patients. The trial aims to optimize image quality and improve the timing and reconstruction of these scans, potentially setting a new standard for bone imaging. This innovation could lead to safer imaging protocols without compromising the detail and accuracy needed for effective diagnosis and monitoring.
What evidence suggests that this PET imaging technique is effective for bone conditions?
Research shows that 18F-NaF PET imaging effectively identifies bone problems. Studies have found it accurately detects bone diseases like cancer and arthritis. Impressively, even with a 60-fold reduction in tracer, image quality remains high. This trial will evaluate ultralow dose 18F-NaF imaging, where participants receive a significantly reduced amount of radiotracer. This approach reduces radiation exposure while maintaining effective results. Additionally, 18F-NaF PET scans have already been used successfully to detect cancer that has spread to the bones. Overall, evidence supports its potential as a powerful tool for diagnosing and monitoring bone diseases.26789
Are You a Good Fit for This Trial?
This trial is for individuals with conditions like bone deformity, osteosarcoma, rheumatoid arthritis, osteomyelitis, or those who are healthy. It's designed to test a new PET imaging technique that could reduce radiation exposure.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants will be injected with a very small amount of radiotracer and imaged on a PET scanner for up to 3 hours to evaluate image quality and optimize timing and reconstruction
Follow-up
Participants are monitored for safety and effectiveness after imaging
What Are the Treatments Tested in This Trial?
Interventions
- 18F-NaF
Trial Overview
The study tests an ultralow dose PET scan using Fluorine-18 (18F)-sodium fluoride (NaF) as a tracer. The goal is to optimize the process to significantly lower the radiation dose compared to current standards while monitoring bone diseases.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Akiva Mintz
Lead Sponsor
Citations
[ 18 F] Sodium Fluoride Dose Reduction Enabled by Digital ...
This study demonstrated that a 60-fold [ 18 F]NaF dose reduction was not significantly different from the highest dose, and it had not significant effect on ...
Sodium 18F-Fluoride PET/CT of Bone, Joint and Other ...
The major goal of this article is to review the current evidence on the diagnostic utility of 18 F-NaF in the imaging assessment of bone and joint in a variety ...
18F-Sodium Fluoride PET Imaging of Osseous Metastatic ...
Published data illustrate the improved diagnostic accuracy of Na18F PET/CT for the detection of osseous metastatic disease, and this technique has been approved ...
F-NaF PET/CT: EANM procedure guidelines for bone ...
The diagnostic and prognostic effectiveness of F-18 sodium fluoride. PET-CT in detecting bone metastases for hepatocellular carcinoma patients.
68Ga-FAPI and 18F-NaF PET/CT in psoriatic arthritis
Similar to our results, Jongh et al. demonstrated that 18F-NaF PET/CT could detect new bone formation at the peripheral joints, entheses, and axial joints [16] ...
[18F] Sodium Fluoride Dose Reduction Enabled by Digital ...
In the future, ultra-low dose [18F]NaF dPET/CT imaging may significantly decrease PET radiation exposure to preclinical subjects and personnel.
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dctd.cancer.gov
dctd.cancer.gov/drug-discovery-development/reagents-materials/imaging-ind-resources/documentation/naf-ib.pdfsodium fluoride f 18 injection investigator's brochure
The tendency for fluoride 18F to accumulate in the vicinity of primary and metastatic malignancy in bone has proven clinically useful in detection of such ...
SNM Guideline for Sodium F-Fluoride PET/CT Bone Scans ...
The procedure guidelines recognize that the safe and effective use of diagnostic nuclear medicine imaging requires specific training, skills, and techniques, as ...
NCT01930812 | 18F-NaF PET Imaging for Bone Scintigraphy
Several studies suggest that 18F-NaF may be more accurate and more sensitive in the detection of bone metastases than 99mTc bone scans.
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