Trial Outcomes & Findings for Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases (NCT NCT00375830)
NCT ID: NCT00375830
Last Updated: 2023-12-12
Results Overview
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").
COMPLETED
PHASE2
114 participants
30 days
2023-12-12
Participant Flow
Participant milestones
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: 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.
Gadofosveset: A gadolinium-based contrast agent for MRI
Gadobutrol: A gadolinium-based contrast agent for MRI
|
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan
Assessment to define the utility of 18F-NaF \& 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: 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.
Gadofosveset: A gadolinium-based contrast agent for MRI
Gadobutrol: A gadolinium-based contrast agent for MRI
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
30
|
74
|
|
Overall Study
COMPLETED
|
10
|
30
|
74
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combined 18F-NaF/18F-FDG PET/MRI for Detection of Skeletal Metastases
Baseline characteristics by cohort
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=10 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 2 WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=30 Participants
Assessment to define the accuracy of the combined 18F-NaF CT \& 18F-FDG PET/CT scan procedures compared to 99mTc MDP bone scan.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: 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.
Gadofosveset: A gadolinium-based contrast agent for MRI
Gadobutrol: A gadolinium-based contrast agent for MRI
|
Cohort 3 Combined 18F-NaF / 18F-FDG PET/WB-MRI Scan
n=74 Participants
Assessment to define the utility of 18F-NaF \& 18F-FDG as the radiolabels in a single combined PET / WB-MRI procedure.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Whole Body Magnetic Resonance Imaging (WB-MRI) scan: 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.
Gadofosveset: A gadolinium-based contrast agent for MRI
Gadobutrol: A gadolinium-based contrast agent for MRI
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
61.6 years
STANDARD_DEVIATION 13.0 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
62.8 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
101 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
30 participants
n=7 Participants
|
74 participants
n=5 Participants
|
114 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: This assessment was conducted only for Cohort 1 as part of the "pilot phase" of the study.
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").
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=10 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
18F-NaF > 99mTc-MDP
|
10 Participants
|
—
|
|
Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
18F-NaF = 99mTc-MDP
|
0 Participants
|
—
|
|
Cohort 1 - NaF PET/CT vs 99mTc-MDP Bone Scintigraphy
18F-NaF < 99mTc-MDP
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: This assessment was conducted only for Cohort 1, and only for participants with skeletal metastases, as part of the "pilot phase" of the study.
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.
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=3 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT
18F-NaF > 18F-FDG
|
3 Participants
|
—
|
|
Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT
18F-NaF = 18F-FDG
|
0 Participants
|
—
|
|
Cohort 1 - 18F-NaF PET/CT vs 18F-FDG PET/CT
18F-NaF < 18F-FDG
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: This assessment was conducted only for Cohort 1 as part of the "pilot phase" of the study. Only participants with medically-evaluable results for both scans are included.
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
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=8 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT
WB MRI > 18F NaF PET/CT
|
5 Participants
|
—
|
|
Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT
WB MRI = 18F NaF PET/CT
|
2 Participants
|
—
|
|
Cohort 1 - Whole-body MRI vs 18F-NaF PET/CT
WB MRI < 18F NaF PET/CT
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: This assessment was conducted only for Cohort 1 as part of the "pilot phase" of the study. Only participants with medically-evaluable results for both scans are included.
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.
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=9 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT
WB MRI > 18F-FDG PET/CT
|
0 Participants
|
—
|
|
Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT
WB MRI = 18F-FDG PET/CT
|
6 Participants
|
—
|
|
Cohort 1 - Whole-body MRI vs 18F-FDG PET/CT
WB MRI < 18F-FDG PET/CT
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 30 daysPopulation: This assessment was conducted only for Cohort 1 as part of the "pilot phase" of the study. Only participants with both medically-evaluable scans are included.
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.
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=9 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
n=9 Participants
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT
Participants with lesions detected by 18F-NaF
|
9 Participants
|
6 Participants
|
|
Cohort 1 - Detection of Osseous (Skeletal) Metastases by 18F-NaF and 18F-FDG PET/CT
Participants with lesions not detected by 18F-NaF
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: For this outcome, participants in Cohort 2 were analyzed with 2 distinct scanning procedures, ie, 18F-NaF/18F-FDG PET/CT scan and whole-body MRI scan.
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.
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=30 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
n=30 Participants
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions
Sensitivity
|
92.9 percentage of particpants
|
92.9 percentage of particpants
|
|
Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions
Positive predictive value
|
81.3 percentage of particpants
|
86.7 percentage of particpants
|
|
Cohort 2 - 18F-NaF/18F-FDG PET/CT vs Whole-body MRI for Detection of Extraskeletal Lesions
Accuracy
|
76.5 percentage of particpants
|
82.4 percentage of particpants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: For this outcome, participants in Cohort 2 were analyzed with 2 distinct scanning procedures, ie, 18F-NaF/18F-FDG PET/CT scan and whole-body MRI scan.
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.
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=30 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
n=30 Participants
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions
Sensitivity
|
96.2 percentage of particpants
|
81.4 percentage of particpants
|
|
Cohort 2 - 18F-NaF/18F-FDG vs Whole-body MRI for Detection of Skeletal Lesions
Accuracy
|
89.8 percentage of particpants
|
74.7 percentage of particpants
|
SECONDARY outcome
Timeframe: 30 daysSensitivity 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.
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=30 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
n=30 Participants
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions
Sensitivity
|
96.2 percentage of participants
|
64.6 percentage of participants
|
|
Cohort 2 - 18F-NaF/18F-FDG vs 99mTc-MDP Bone Scintigraphy for Detection of Skeletal Lesions
Accuracy
|
89.8 percentage of participants
|
65.9 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysOverall 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.
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=30 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
n=30 Participants
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI
Sensitivity
|
95.7 percentage of participants
|
83.3 percentage of participants
|
|
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI
Accuracy
|
87.6 percentage of participants
|
76.0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysOverall 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.
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=30 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
n=30 Participants
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy
Sensitivity
|
95.7 percentage of participants
|
91.6 percentage of participants
|
|
Cohort 2 - Overall Sensitivity and Accuracy for 18F-NaF/18F-FDG vs Whole-body MRI/99mTc-MDP Bone Scintigraphy
Accuracy
|
87.6 percentage of participants
|
83.0 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysParticipants 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.
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=74 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
n=74 Participants
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 3 - Skeletal Lesions Identified by 99mTc MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
|
37 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 30 daysParticipants 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.
Outcome measures
| Measure |
Cohort 1 Pilot-WB-MRI & Combined 18F-NaF-CT/18F-FDG-PET Scans
n=74 Participants
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.
Bone scan: Scan to diagnose a number of bone conditions including cancer or metastasis
99mTc-methyl diphosphonate: Radiolabel for bone scan procedures
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
18F-Sodium Fluoride (18F-NaF): Radiolabel for CT and PET scans, \& as a contrast agent for MRI scans.
Gadopentetate dimeglumine: A gadolinium-based contrast agent for MRI
|
Cohort 1 Pilot - 18F-FDG-PET Scan
n=74 Participants
Preliminary pilot assessment to confirm feasibility \& improved diagnostic accuracy of the 18F-NaF CT \& 18F-FDG PET scan procedures.
Positron Emission Tomography (PET) scan: Scan to detect gamma rays emitted by a positron-emitting radioligand such as 18F
18F-Fludeoxyglucose (18F-FDG): Radiolabel for positron emission tomography scan procedures
Computed Tomography (CT) scan: Scan to detect \& analyze X-rays
|
|---|---|---|
|
Cohort 3 - Total Skeletal Lesions Identified, Tc-99m MDP WBBS vs 18F-NaF / 18F-FDG PET/MRI
|
81 lesions
|
140 lesions
|
Adverse Events
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
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andrei Iagaru, Professor of Radiology (Nuclear Medicine)
Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place