Brain Imaging, Whole Body Imaging
Conditions
Keywords
Brain Imaging, Whole Body Imaging
Brief summary
The purpose of this study is to assess the effectiveness of new software available on a new PET/CT scanner in the Molecular Imaging Research PET/CT Facility. Further, the study aims to evaluate the data acquisition and image processing workflow.
Detailed description
The study will be separated into three cohorts: Motion Correction, Parametric Imaging, and MAP Reconstruction. The motion correction (Aim 1) cohort will involve a group of 30 subjects who are already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and are scheduled to be scanned on the Siemens Biograph Vision 600 PET/CT system in the PET/CT Molecular Imaging Research Center in Charlton 6 of Mayo Clinic Rochester. The data gathered from this cohort will assess the effectiveness of motion correction software for patients undergoing PET brain scans. The parametric imaging (Aim 2) cohort will include 30 subjects that have recently undergone a brain or whole body oncologic PET/CT scans on the V600-R1. The purpose of this cohort is to assess the data acquisition and image processing workflow for parametric analysis of brain and whole body scans. The MAP Reconstruction Cohort (Aim 3) is a retrospective study to assess the quality of PET images reconstructed with maximum a posteriori (MAP) reconstruction algorithm.
Interventions
DRUG18F-FDG
A cohort of participants in Aim 2 will undergo a 18F-FDG PET/CT scan. This scan is done with a radiotracer called 18F-fluorodeoxyglucose (FDG). FDG looks at cellular activity.
DRUG18F-AV1451
A cohort of participants in Aim 2 will undergo a 18F-AV1451 PET/CT scan. This scan is done with a radiotracer called 18F-AV1451 (TAU) that will find small areas of tau (abnormal protein) in the brain.
DEVICESiemens E7 Reconstruction Tool
Software to correct for motion
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Participants are assigned to two groups in parallel for the duration of the study. Aim 1 involves the prospective data collection of subjects who are already enrolled in Mayo Clinic Rochester research study 08-005553 (PI: Dr Val Lowe) and are 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. Aim 2 involves the prospective data collection of subjects undergoing brain or whole body oncologic PET/CT scans on the V600-R1.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older * Subjects who are able and willing to sign the informed consent * Subjects who are able to follow verbal commands * A negative urine pregnancy test within 48 hours prior to PET imaging procedures in females of childbearing potential * Subjects who are scheduled for a PET/CT study under Mayo Clinic Rochester IRB research protocol 08-005553 (Aim 1 cohort only) * A positive 18F-FDG oncology PET/CT exam in the last six months (Aim 2 cohort only)
Exclusion criteria
* Patients who are unable to lay still for an additional 15 minutes (for Aim 1 cohort) * Patients who are unable to lay still for 90 min for 18F-FDG scans or 100 min for 18F-AV1451 scans (for Aim 2 cohort) * Patients who cannot follow the prep instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motion Correction | 2 years | 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. |
| Parametric Imaging | 2 years | Metabolic rate of 18F-FDG measured from dynamic PET images. Uptake rate constant Ki in the grey matter of the brain. |
| Map Reconstruction | 2 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 30 |
| 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. | 20 |
| 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. | 30 |
| Total | 80 |
Baseline characteristics
| Characteristic | Motion Correction | Parametric Imaging | MAP Reconstruction | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 7 Participants | 17 Participants | 40 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 13 Participants | 13 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 20 Participants | 28 Participants | 78 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 29 Participants | 20 Participants | 30 Participants | 79 Participants |
| Region of Enrollment United States | 30 participants | 20 participants | 30 participants | 80 participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 14 Participants | 37 Participants |
| Sex: Female, Male Male | 17 Participants | 10 Participants | 16 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 20 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 20 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 20 | 0 / 30 |
Outcome results
Primary
Map Reconstruction
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.
Time frame: 2 years
Population: This outcome measure was collected and analyzed for the MAP reconstruction arm only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Motion Correction | Map Reconstruction | SNR in liver for OPTOF | 17 ratio |
| Motion Correction | Map Reconstruction | SNR in liver for MAP | 16 ratio |
| Motion Correction | Map Reconstruction | SNR in lesions for OPTOF | 37 ratio |
| Motion Correction | Map Reconstruction | SNR in lesions for MAP | 48 ratio |
Primary
Motion Correction
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.
Time frame: 2 years
Population: This outcome measure was collected and analyzed for the Motion Correction arm only.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motion Correction | Motion Correction | without motion correction | 57.4 percentage of voxels | Standard Deviation 8.5 |
| Motion Correction | Motion Correction | with motion correction | 13.9 percentage of voxels | Standard Deviation 7.4 |
Primary
Parametric Imaging
Metabolic rate of 18F-FDG measured from dynamic PET images. Uptake rate constant Ki in the grey matter of the brain.
Time frame: 2 years
Population: This outcome measure was collected and analyzed for the Parametric Imaging arm only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Motion Correction | Parametric Imaging | 0.0311 ml/min/ml | Standard Deviation 0.0025 |