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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study will look at two new technologies being developed for measuring cancer in bones. One of these technologies is a substance called Sodium Fluoride (NaF). Fluoride is a normal body substance. The amount that patients will receive has been shown to be very safe. One study of over 400 patients showed no adverse reactions after receiving the recommended dosage.
NaF (known as a radiotracer) is taken up into the bones under a normal process and researchers can measure the amount within patient's bones through an imaging system called a Positron Emission Tomography/Magnetic Resonance Imaging (PET/MRI). This system combines aspects of both a PET study as part of the regular standard of care and an MRI study. The belief is that the combination of these two studies will be better than either study alone.People who have enrolled in this study will receive their clinically requested PET/CT scan as part of their normal diagnostic care and will follow all the said recommendations for this study such as not being pregnant, having fasted overnight, etc. Subjects will return within 7 days for a 10 mCi NaF PET/MRI study. The patients' imaging time will be up to 120 minutes depending on the MRI sequences acquired. Imaging for the PET portion of the study will take approximately 20-30 minutes with the rest of the time devoted to MRI sequences.
The primary aim of this study is to assess NaF PET/MRI compared to NaF PET/CT and standard of care imaging made available for assessment of bone metastases in all cancers as well as other standard of care indications for MDP bone scintigraphy. The study will use both the currently available and approved MRI sequences for attenuation correction and localization as well as non FDA approved sequences to assess the ability of the modality to identify bone metastases.
Study Goals:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lesion Imaging | Image patients with the standard of care of a FDG PET/CT and the experimental method of the NaF PET/MRI and compare the number of images found within and between patients to determine the most effective way of looking at breast cancers metastasized to bone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NaF PET/MRI | Device |
| ||
| NaF PET/CT |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of NaF PET/MRI | The difference in the number of lesions detected by the two imaging methods using McNamar's test | 2 years after beginning of study |
| Measure | Description | Time Frame |
|---|---|---|
| Image Quality | Mean quality score ranging from 1-5 using different methods will be compared using paired t-tests. With a sample size of 150 lesions, a difference of 0.25 points in mean quality score can be detected with 86% power. | 2 years after beginning of study |
| Positive predictive value of MRI sequences |
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Inclusion Criteria:
Exclusion Criteria:
Patients who cannot tolerate imaging up to 120 minutes of total imaging (breaks of several minutes between imaging will be available)
Pregnant or breast feeding women.
Healthy volunteers
Inability to comply with instructions
MRI contraindications Include:
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Breast cancer patients who present for bone imaging as per Tc-methylene diphosphonate (MDP) bone scan standard of care indications
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Jones, MD | University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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NaF PET/CT images will be obtained through fusion software. Researchers will fuse the Non AC and AC NaF images with the low dose CT obtained in the FDG PET/CT study. |
|
| FDG PET/CT | Device |
|
The difference in positive predictive value of bone metastases detected by MRI sequences as compared to other modalities as calculated using McNamar's test. |
| 2 years from beginning of study |
| Negative predictive value of MRI sequences | The difference in Negative predictive value of bone metastases detected by MRI sequences as compared to other modalities as calculated using McNamar's test. | 2 years from beginning of study |
| Specificity of MRI sequences | The difference in specificity of bone metastases detected by MRI sequences as compared to other modalities as calculated using McNamar's test. | 2 years from beginning of study |
| attenuation correction | Difference in attenuation correction of NaF MRI-based and NaF CT-based images as calculated using McNamar's test. | 2 years after beginning of study |
| localization | Difference in localization of NaF MRI-based and NaF CT-based images as calculated using McNamar's test. | 2 years after beginning of study |
| Evaluation of Bone Metastases | Difference in bone metastases detected by MRI attenuation correction images compared to diagnostic quality images. | 2 years after beginning of study |
| D017437 |
| Skin and Connective Tissue Diseases |