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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motion Correction | Active Comparator | 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. The purpose of this arm is to evaluate the effectiveness of motion correction software. |
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| Parametric Imaging | Active Comparator | Aim 2 involves the prospective data collection of subjects undergoing brain or whole body oncologic PET/CT scans on the V600-R1. The purpose of this arm is to evaluate the data acquisition and image processing workflow. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FDG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Parametric Imaging | Metabolic rate of 18F-FDG measured from dynamic PET images. Uptake rate constant Ki in the grey matter of the brain. | 2 years |
| 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. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Kemp, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| SNMMI abstract on parametric imaging | View source |
| SNMMI abstract on brain motion correction | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This outcome measure was collected and analyzed for the Motion Correction arm only. | Posted | Mean | Standard Deviation | percentage of voxels | 2 years |
|
Adverse Events were collected at baseline, for approximately fifteen minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradley J. Kemp, Ph.D. | Mayo Clinic | 507-284-4399 | Kemp.Brad@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 3, 2024 | Dec 17, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| C000591008 | 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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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.
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| 18F-AV1451 | Drug | 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. |
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| Siemens E7 Reconstruction Tool | Device | Software to correct for motion |
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| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Parametric Imaging | Metabolic rate of 18F-FDG measured from dynamic PET images. Uptake rate constant Ki in the grey matter of the brain. | This outcome measure was collected and analyzed for the Parametric Imaging arm only. | Posted | Mean | Standard Deviation | ml/min/ml | 2 years |
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| 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. | This outcome measure was collected and analyzed for the MAP reconstruction arm only. | Posted | Median | Full Range | ratio | 2 years |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Measurements |
|---|---|
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| SNR in lesions for MAP |
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