A Phase 2 interventional study of Bone scan and 99mTc-methyl diphosphonate in Cancer, sponsored by Stanford University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Stanford University · Phase 2, Interventional, and Diagnostic
This clinical trial studies the use of sodium fluorine-18 (18F-NaF) plus fluorine-18 (18F) fluorodeoxyglucose (FDG) positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI) to detect skeletal metastases in patients with stage III-IV breast cancer or stage II-IV prostate cancer.
Eligible participants had previously received a bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP) as part of their regular medical care.
18F-NaF and 18F-FDG are radioactive substances (radiolabels) that are absorbed by cancerous cells and allow for the cancer to be found using diagnostic procedures such as positron emission tomography (PET)/ whole body magnetic resonance imaging (WBMRI). PET/WBMRI is a combination procedure that combines the detailed PET images of areas inside the body from PET with the WBMRI scans, and may help find and diagnose skeletal metastases in patients with breast or prostate cancer. It is not yet known whether 18F-NaF/18F-FDG PET/WBMRI is better than standard imaging methods in detecting skeletal metastases.
Eligible participants diagnosed with breast/prostate cancers and who have had 99mTc MDP bone scanning as part of their routine care are recruited and enrolled. Participants then receive an 18F-NaF/18F-FDG positron emission tomography (PET)/ WBMRI combination scan.
The PET/MRI scans will be interpreted by 2 American Board Nuclear Medicine (ABNM)-certified physicians and 2 American Board of Radiology (ABR)-certified radiologists, all with significant clinical experience, who are blinded to the subjects' medical history and the results of other imaging modalities.
The scans will be analyzed and compared against each other, with a consensus read will be obtained for each scan. Characterization of lesions as true-positive, true-negative, false-positive or false-negative will be done through a combination of clinical follow-up, imaging follow-up and/or histopathology findings. An overall diagnosis based on each scan will be determined on a 5-point scale (1=benign, 2=likely benign, 3=uncertain, 4=likely malignant, 5=malignant) to conduct a receiver operating characteristic (ROC) analysis.
If the diagnosis is positive for metastases on any of the scans, the investigator will identify the number of lesions and locations of positivity, and record this information.
Clinical is obtained at about 12 months after the initial scans.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 114 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients were enrolled after receiving a regular medical care bone scan using the radiolabel 99mTc-methyl diphosphonate (t99-MDP).
INCLUSION CRITERIA
EXCLUSION CRITERIA
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the combined 18F-NaF CT \& 18F-FDG PET scan procedures, as compared to the regular medical care procedure, 99mTc MDP bone scans.
Procedure: Bone scan · Drug: 99mTc-methyl diphosphonate · Procedure: Positron Emission Tomography (PET) scan · Drug: 18F-Fludeoxyglucose (18F-FDG) · Procedure: Computed Tomography (CT) scan · Drug: 18F-Sodium Fluoride (18F-NaF) · Drug: Gadopentetate dimeglumine
Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
Procedure: Bone scan · Drug: 99mTc-methyl diphosphonate · Procedure: Positron Emission Tomography (PET) scan · Drug: 18F-Fludeoxyglucose (18F-FDG) · Procedure: Computed Tomography (CT) scan · Drug: 18F-Sodium Fluoride (18F-NaF) · Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan · Drug: Gadofosveset · Drug: Gadobutrol
Assessment to define the utility of 18F-NaF \& 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
Procedure: Bone scan · Drug: 99mTc-methyl diphosphonate · Procedure: Positron Emission Tomography (PET) scan · Drug: 18F-Fludeoxyglucose (18F-FDG) · Drug: 18F-Sodium Fluoride (18F-NaF) · Procedure: Whole Body Magnetic Resonance Imaging (WB-MRI) scan · Drug: Gadofosveset · Drug: Gadobutrol
Scan to diagnose a number of bone conditions including cancer or metastasis
Also known as: Bone scintigraphy
Radiolabel for bone scan procedures
Also known as: 99mTc-methylene diphosphonate, Technetium 99mTc medronate, 99mTc-MDP, t99-MDP
Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
Radiolabel for positron emission tomography scan procedures
Also known as: 2-Deoxy-2-(18F)Fluoro-D-Glucose, 2-F18-Fluoro-2-deoxy-D-glucose, 2-F18-Fluoro-2-deoxyglucose, 18F 2-Fluoro-2-deoxy-D-Glucose, Fludeoxyglucose F-18, Fluorodeoxyglucose F18
Scan to detect \& analyze X-rays
Also known as: Computerized Axial Tomograph (CAT) scan, Computer-aided Tomography (CAT) scan
Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Also known as: 18F-Sodium Fluorine
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: Scan that uses strong magnetic fields \& radio waves to generate images of the organs in the body.
A gadolinium-based contrast agent for MRI
Also known as: Magnevist
A gadolinium-based contrast agent for MRI
Also known as: Ablavar
A gadolinium-based contrast agent for MRI
Also known as: Gadavist
Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF \> 99mTc-MDP"), the same between both scans ("18F-NaF = 99mTc-MDP"), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF \< 99mTc-MDP").
Time frame: 30 days
Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant diagnosed with osseous (skeletal) metastases. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18-NaF PET/CT compared to 18F-FDG PET/CT, the same between both scans, or inferior for 18-NaF PET/CT compared to 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.
Time frame: 30 days
Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT
The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was \> 18F-NaF PET/CT; equal to 18F-NaF PET/CT; or \< 18F-NaF PET/CT. The outcome result is represented as a number without dispersion. 8 analyzed 5 2 1
Time frame: 30 days
Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT
The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was \> 18F-FDG PET/CT; equal to to 18F-FDG PET/CT; or \< 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.
Time frame: 30 days
Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT
The ability of 18F-sodium fluoride (NaF) and 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) to detect osseous (skeletal) metastases was assessed. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of Cohort 1 participants for whom osseous metastases were detected, a number without dispersion.
Time frame: 30 days
Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions
Sensitivity; positive predictive value (PPV); and accuracy for the detection of extraskeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). * Sensitivity is a percentage that defines the proportion of true positive participants with the disease in a total group of participants. * PPV is the probability that participants with a positive screening test truly have the disease. * Accuracy is the proportion of true results (both true positives and true negatives) among the total number of cases examined. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity, PPV, and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Time frame: 30 days
Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions
Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Time frame: 30 days
Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions
Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Time frame: 30 days
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI
Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Time frame: 30 days
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy
Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
Time frame: 30 days
Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, participants with skeletal lesions were identified. The outcome is reported as the number of Cohort 3 participants for whom skeletal lesions were identified by each scan methodology, a number without dispersion.
Time frame: 30 days
Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, the total number skeletal lesions identified in the participants was determined. The outcome is reported as the total number skeletal lesions identified by each scan methodology, a number without dispersion.
Time frame: 30 days
| Milestone | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan |
|---|---|---|---|
| Started | 10 | 30 | 74 |
| Completed | 10 | 30 | 74 |
| Not completed | 0 | 0 | 0 |
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 99mTc-methylene diphosphonate (MDP) bone scintigraphy was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF \> 99mTc-MDP"), the same between both scans ("18F-NaF = 99mTc-MDP"), or inferior for 18F-NaF vs 99mTc-MDP bone scintigraphy ("18F-NaF \< 99mTc-MDP").
| Participants | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans |
|---|---|
| 18F-NaF > 99mTc-MDP | 10 |
| 18F-NaF = 99mTc-MDP | 0 |
| 18F-NaF < 99mTc-MDP | 0 |
The medical value of 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of the radiation oncologist's medical assessment of image quality and detected extent of disease, for each participant diagnosed with osseous (skeletal) metastases. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom the medical value of the image was superior for 18-NaF PET/CT compared to 18F-FDG PET/CT, the same between both scans, or inferior for 18-NaF PET/CT compared to 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.
| Participants | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans |
|---|---|
| 18F-NaF > 18F-FDG | 3 |
| 18F-NaF = 18F-FDG | 0 |
| 18F-NaF < 18F-FDG | 0 |
The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-sodium fluoride (NaF) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was \> 18F-NaF PET/CT; equal to 18F-NaF PET/CT; or \< 18F-NaF PET/CT. The outcome result is represented as a number without dispersion. 8 analyzed 5 2 1
| Participants | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans |
|---|---|
| WB MRI > 18F NaF PET/CT | 5 |
| WB MRI = 18F NaF PET/CT | 2 |
| WB MRI < 18F NaF PET/CT | 1 |
The medical value of whole body magnetic imaging resonance (WB-MRI) vs 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) was assessed on the basis of which scan detected the greater number of tumor lesions in each participant. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of participants for whom lesions detected by WB MRI was \> 18F-FDG PET/CT; equal to to 18F-FDG PET/CT; or \< 18F-FDG PET/CT. The outcome result is represented as a number without dispersion.
| Participants | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans |
|---|---|
| WB MRI > 18F-FDG PET/CT | 0 |
| WB MRI = 18F-FDG PET/CT | 6 |
| WB MRI < 18F-FDG PET/CT | 3 |
The ability of 18F-sodium fluoride (NaF) and 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) to detect osseous (skeletal) metastases was assessed. Per protocol, the data were collected and the outcome is reported for Cohort 1 only. The outcome is reported as the number of Cohort 1 participants for whom osseous metastases were detected, a number without dispersion.
| Participants | Cohort 1 Pilot - 18F-NaF-CT Scan | Cohort 1 Pilot - 18F-FDG-PET Scan |
|---|---|---|
| Participants with lesions detected by 18F-NaF | 9 | 6 |
| Participants with lesions not detected by 18F-NaF | 0 | 3 |
Sensitivity; positive predictive value (PPV); and accuracy for the detection of extraskeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). * Sensitivity is a percentage that defines the proportion of true positive participants with the disease in a total group of participants. * PPV is the probability that participants with a positive screening test truly have the disease. * Accuracy is the proportion of true results (both true positives and true negatives) among the total number of cases examined. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity, PPV, and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
| percentage of particpants | Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan | Cohort 2 - Whole Body-MRI Scan |
|---|---|---|
| Sensitivity | 92.9 | 92.9 |
| Positive predictive value | 81.3 | 86.7 |
| Accuracy | 76.5 | 82.4 |
Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
| percentage of particpants | Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan | Cohort 2 - WB-MRI Scan |
|---|---|---|
| Sensitivity | 96.2 | 81.4 |
| Accuracy | 89.8 | 74.7 |
Sensitivity and accuracy for the detection of skeletal lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
| percentage of participants | Cohort 2 Combined 18F-NaF-CT/18F-FDG-PET Scan | Cohort 2 - 99mTc-MDP Bone Scintigraphy Scan |
|---|---|---|
| Sensitivity | 96.2 | 64.6 |
| Accuracy | 89.8 | 65.9 |
Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for whole body magnetic imaging resonance (WB-MRI). Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
| percentage of participants | Cohort 2 - Combined 18F-NaF-CT/18F-FDG-PET Scan | Cohort 2 - Whole Body Magnetic Resonance Imaging (WB-MRI) Scan |
|---|---|---|
| Sensitivity | 95.7 | 83.3 |
| Accuracy | 87.6 | 76.0 |
Overall sensitivity and accuracy for the detection of tumor lesions was assessed for 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / computed tomography (PET/CT) and for 99mTc-methylene diphosphonate (MDP) bone scintigraphy. Per protocol, the data were collected and the outcome is reported for Cohort 2 only. Sensitivity and accuracy are reported as a percentage, a number without dispersion. Higher numbers represent better detection.
| percentage of participants | Cohort 2 Combined 18F-NaF-CT/18F-FDG-PET Scan | Cohort 2 WB-MRI & 99mTc-MDP Bone Scintigraphy |
|---|---|---|
| Sensitivity | 95.7 | 91.6 |
| Accuracy | 87.6 | 83.0 |
Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, participants with skeletal lesions were identified. The outcome is reported as the number of Cohort 3 participants for whom skeletal lesions were identified by each scan methodology, a number without dispersion.
| Participants | Cohort 3 - 99mTc-methyl Diphosphonate (MDP) Bone Scan | Cohort 3 - 18F-NaF / 18F-FDG PET/MRI |
|---|---|---|
| Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI | 37 | 45 |
Participants in Cohort 3 received 99mTc-methylene diphosphonate (MDP) whole-body bone scintigraphy (WBBS) and 18F-sodium fluoride (NaF) / 18F-fluorodeoxyglucose (FDG) positron emission tomography / magnetic imaging resonance (PET/MRI) scans. On the basis of the scans, the total number skeletal lesions identified in the participants was determined. The outcome is reported as the total number skeletal lesions identified by each scan methodology, a number without dispersion.
| lesions | Cohort 3 - 99mTc-methyl Diphosphonate (MDP) Bone Scan | Cohort 3 - 18F-NaF / 18F-FDG PET/MRI |
|---|---|---|
| Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI | 81 | 140 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan | 0/74 (0%) | 0/74 (0%) | 0/74 (0%) |
| Age, Categorical(Participants) | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 16 | 42 | 63 |
| >=65 years | 5 | 14 | 32 | 51 |
| Age, Continuous(years) | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan | Total |
|---|---|---|---|---|
| Mean | 62.5 ± 11.8 | 61.6 ± 13.0 | 62.9 ± 11.2 | 62.8 ± 11.5 |
| Sex: Female, Male(Participants) | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan | Total |
|---|---|---|---|---|
| Female | 5 | 15 | 23 | 43 |
| Male | 5 | 15 | 51 | 71 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 6 | 7 |
| Not Hispanic or Latino | 7 | 28 | 66 | 101 |
| Unknown or Not Reported | 3 | 1 | 2 | 6 |
| Race (NIH/OMB)(Participants) | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 2 | 5 | 14 | 21 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| Black or African American | 0 | 0 | 2 | 2 |
| White | 5 | 18 | 52 | 75 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 6 | 6 | 15 |
| Region of Enrollment(participants) | Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans | Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan | Total |
|---|---|---|---|---|
| United States | 10 | 30 | 74 | 114 |
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