Trial Outcomes & Findings for PET/CT or PET/MRI in Measuring Tumors in Patients Undergoing Clinical Imaging or With Newly Diagnosed Breast Cancer (NCT NCT01892540)
NCT ID: NCT01892540
Last Updated: 2020-03-04
Results Overview
Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals.
COMPLETED
NA
43 participants
1 yr from study start
2020-03-04
Participant Flow
Participant milestones
| Measure |
Cohort 1: Standard Positioning Device
Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA.
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
|
Cohort 2: New Positioning Device
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Position Device
|
Cohort 3: Current Positioning Device Until New is Available
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Position Device
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
0
|
28
|
|
Overall Study
COMPLETED
|
15
|
0
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Cohort 1: Standard Positioning Device
Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA.
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
|
Cohort 2: New Positioning Device
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Position Device
|
Cohort 3: Current Positioning Device Until New is Available
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Position Device
|
|---|---|---|---|
|
Overall Study
Did not complete PET/MRI
|
0
|
0
|
2
|
|
Overall Study
Did not fit in scanner
|
0
|
0
|
1
|
Baseline Characteristics
PET/CT or PET/MRI in Measuring Tumors in Patients Undergoing Clinical Imaging or With Newly Diagnosed Breast Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1: Standard Positioning Device
n=15 Participants
Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA.
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
|
Cohort 2: New Positioning Device
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Position Device
|
Cohort 3: Current Positioning Device Until New is Available
n=28 Participants
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Position Device
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
30-39 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Age, Customized
40-49 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Customized
50-59 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Customized
60-69 years
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Age, Customized
70-79 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Gender · Unknown
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
31 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
—
|
28 participants
n=5 Participants
|
43 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yr from study startPopulation: No data available - SUV data do not exist for Cohort I and cohort II was never conducted.
Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yr from study startPopulation: No data available - SUV data do not exist for Cohort I and cohort II was never conducted.
Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yr from study startPopulation: Participants in cohort 3 that completed scans.
McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare specificity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest specificity. Single parameter: DCE-MRI is the gold standard to which the two parameter and three parameter rows are compared. Combinations include: Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET
Outcome measures
| Measure |
Cohort 1: Standard Positioning Device
Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA.
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
|
Cohort 2: New Positioning Device
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Position Device
|
Cohort 3: Current Positioning Device Until New is Available
n=25 Participants
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Position Device
|
|---|---|---|---|
|
Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III)
Single parameter: DCE-MRI
|
—
|
—
|
0 percent of specificity
Interval 0.0 to 0.0
|
|
Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III)
Two Parameter A: DCE-MRI and DWI ADC
|
—
|
—
|
89 percent of specificity
Interval 52.0 to 100.0
|
|
Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III)
Two Parameter B: DCE-MRI and FDG-PET
|
—
|
—
|
89 percent of specificity
Interval 52.0 to 100.0
|
|
Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III)
Three Parameter: DCE-MRI, DWI ADC, FDG-PET
|
—
|
—
|
100 percent of specificity
Interval 66.0 to 100.0
|
PRIMARY outcome
Timeframe: 1 yr from study startPopulation: Participants in cohort 3 that completed scans.
McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare sensitivity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest sensitivity. Combinations include: Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET
Outcome measures
| Measure |
Cohort 1: Standard Positioning Device
Patients undergo clinical FDG-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without DTPA.
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
|
Cohort 2: New Positioning Device
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Position Device
|
Cohort 3: Current Positioning Device Until New is Available
n=25 Participants
positron emission tomography/computed tomography: Undergo PET/CT
PET/MRI: Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Position Device
|
|---|---|---|---|
|
Sensitivity of PET/CT and PET/MRI (Cohort III)
Single parameter: DCE-MRI
|
—
|
—
|
100 percent sensitivity
Interval 100.0 to 100.0
|
|
Sensitivity of PET/CT and PET/MRI (Cohort III)
Two Parameter A: DCE-MRI and DWI ADC
|
—
|
—
|
95 percent sensitivity
Interval 83.0 to 100.0
|
|
Sensitivity of PET/CT and PET/MRI (Cohort III)
Two Parameter B: DCE-MRI and FDG-PET
|
—
|
—
|
86 percent sensitivity
Interval 71.0 to 100.0
|
|
Sensitivity of PET/CT and PET/MRI (Cohort III)
Three Parameter: DCE-MRI, DWI ADC, FDG-PET
|
—
|
—
|
85 percent sensitivity
Interval 70.0 to 94.0
|
Adverse Events
Cohort 1: Standard Positioning Device
Cohort 2: New Positioning Device
Cohort 3: Current Positioning Device Until New is Available
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place