Trial Outcomes & Findings for Improving PET Image Quality and Quantification by Using Motion Correction, Parametric Imaging and MAP Reconstruction (NCT NCT04417998)
NCT ID: NCT04417998
Last Updated: 2025-01-22
Results Overview
Confirm that motion-corrected reconstructed images acquired when the subject was moving provides similar image quality to the baseline reference reconstructed images acquired when the subject was instructed to remain still. For each subject compute the cumulative absolute relative difference (ARD) histogram in standard uptake values in grey matter voxels in images with and without motion correction versus a reference image for which the subject was stationary, then calculate the percentage of voxels with an ARD greater than 10%. Calculate mean and standard deviation across all subjects. For this measurement 0% is ideal.
COMPLETED
PHASE4
80 participants
2 years
2025-01-22
Participant Flow
Participant milestones
| Measure |
Motion Correction
Motion Correction involved the prospective data collection of subjects who were already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and were scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system (hereafter referred to as the V600-R1) in the PET/CT Molecular Imaging Research Center on Charlton 6 of Mayo Clinic Rochester. The purpose of this arm was to evaluate the effectiveness of motion correction software.
Siemens E7 Reconstruction Tool: Software to correct for motion
|
Parametric Imaging
Parametric Imaging involved the prospective data collection of subjects who underwent brain or whole-body oncologic PET/CT scans on the V600-R1. The purpose of this arm was to evaluate the data acquisition and image processing workflow.
18F-FDG: participants underwent a 18F-FDG PET/CT scan. This scan was done with a radiotracer called 18F-fluorodeoxyglucose (FDG). FDG looks at cellular activity.
18F-AV1451: participants underwent a 18F-AV1451 PET/CT scan. This scan was done with a radiotracer called 18F-AV1451 (TAU) that finds small areas of tau (abnormal protein) in the brain.
|
MAP Reconstruction
MAP reconstruction involved the retrospective data collection of clinically indicated patient scans with the new MAP reconstruction algorithm and compared it to our standard reconstruction algorithm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
20
|
30
|
|
Overall Study
COMPLETED
|
30
|
20
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving PET Image Quality and Quantification by Using Motion Correction, Parametric Imaging and MAP Reconstruction
Baseline characteristics by cohort
| Measure |
Motion Correction
n=30 Participants
Motion Correction involved the prospective data collection of subjects who were already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and were scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system (hereafter referred to as the V600-R1) in the PET/CT Molecular Imaging Research Center on Charlton 6 of Mayo Clinic Rochester. The purpose of this arm was to evaluate the effectiveness of motion correction software.
Siemens E7 Reconstruction Tool: Software to correct for motion
|
Parametric Imaging
n=20 Participants
Parametric Imaging involved the prospective data collection of subjects who underwent brain or whole-body oncologic PET/CT scans on the V600-R1. The purpose of this arm was to evaluate the data acquisition and image processing workflow.
18F-FDG: participants underwent a 18F-FDG PET/CT scan. This scan was done with a radiotracer called 18F-fluorodeoxyglucose (FDG). FDG looks at cellular activity.
18F-AV1451: participants underwent a 18F-AV1451 PET/CT scan. This scan was done with a radiotracer called 18F-AV1451 (TAU) that finds small areas of tau (abnormal protein) in the brain.
|
MAP Reconstruction
n=30 Participants
MAP reconstruction involved the retrospective data collection of clinically indicated patient scans with the new MAP reconstruction algorithm and compared it to our standard reconstruction algorithm.
|
Total
n=80 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
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
43 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
|
30 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
78 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
79 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
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
20 participants
n=7 Participants
|
30 participants
n=5 Participants
|
80 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: This outcome measure was collected and analyzed for the Motion Correction arm only.
Confirm that motion-corrected reconstructed images acquired when the subject was moving provides similar image quality to the baseline reference reconstructed images acquired when the subject was instructed to remain still. For each subject compute the cumulative absolute relative difference (ARD) histogram in standard uptake values in grey matter voxels in images with and without motion correction versus a reference image for which the subject was stationary, then calculate the percentage of voxels with an ARD greater than 10%. Calculate mean and standard deviation across all subjects. For this measurement 0% is ideal.
Outcome measures
| Measure |
Motion Correction
n=30 Participants
Motion Correction involved the prospective data collection of subjects who were already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and were scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system (hereafter referred to as the V600-R1) in the PET/CT Molecular Imaging Research Center on Charlton 6 of Mayo Clinic Rochester. The purpose of this arm was to evaluate the effectiveness of motion correction software.
Siemens E7 Reconstruction Tool: Software to correct for motion
|
|---|---|
|
Motion Correction
without motion correction
|
57.4 percentage of voxels
Standard Deviation 8.5
|
|
Motion Correction
with motion correction
|
13.9 percentage of voxels
Standard Deviation 7.4
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: This outcome measure was collected and analyzed for the Parametric Imaging arm only.
Metabolic rate of 18F-FDG measured from dynamic PET images. Uptake rate constant Ki in the grey matter of the brain.
Outcome measures
| Measure |
Motion Correction
n=20 Participants
Motion Correction involved the prospective data collection of subjects who were already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and were scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system (hereafter referred to as the V600-R1) in the PET/CT Molecular Imaging Research Center on Charlton 6 of Mayo Clinic Rochester. The purpose of this arm was to evaluate the effectiveness of motion correction software.
Siemens E7 Reconstruction Tool: Software to correct for motion
|
|---|---|
|
Parametric Imaging
|
0.0311 ml/min/ml
Standard Deviation 0.0025
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: This outcome measure was collected and analyzed for the MAP reconstruction arm only.
Confirm that maximum a posteriori reconstructed PET images are diagnostically acceptable. Calculate the Signal-to-Noise ratio (SNR) of the liver and of lesions in images reconstructed with clinical reconstruction (OPTOF) and with MAP (maximum a posteriori) reconstruction. Compute the median and range of SNR for liver and lesions for OPTOF and MAP reconstructions.
Outcome measures
| Measure |
Motion Correction
n=30 Participants
Motion Correction involved the prospective data collection of subjects who were already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and were scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system (hereafter referred to as the V600-R1) in the PET/CT Molecular Imaging Research Center on Charlton 6 of Mayo Clinic Rochester. The purpose of this arm was to evaluate the effectiveness of motion correction software.
Siemens E7 Reconstruction Tool: Software to correct for motion
|
|---|---|
|
Map Reconstruction
SNR in liver for OPTOF
|
17 ratio
Interval 11.0 to 29.0
|
|
Map Reconstruction
SNR in liver for MAP
|
16 ratio
Interval 12.0 to 31.0
|
|
Map Reconstruction
SNR in lesions for OPTOF
|
37 ratio
Interval 10.0 to 182.0
|
|
Map Reconstruction
SNR in lesions for MAP
|
48 ratio
Interval 14.0 to 275.0
|
Adverse Events
Motion Correction
Parametric Imaging
MAP Reconstruction
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