Improving PET Image Quality and Quantification by Using Motion Correction, Parametric Imaging and MAP Reconstruction

Study Overview
=================
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.

Official Title
-----------------
Improving PET Image Quality and Quantification by Using Motion Correction, Parametric Imaging and MAP Reconstruction

Conditions
-----------------
Brain Imaging, Whole Body Imaging

Intervention / Treatment
-----------------
* Drug: 18F-FDG
* Drug: 18F-AV1451
* Device: Siemens E7 Reconstruction Tool


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Motion Correction<br>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. | Device: Siemens E7 Reconstruction Tool<br>* Software to correct for motion<br>|
| Active Comparator: Parametric Imaging<br>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. | Drug: 18F-FDG<br>* 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.<br>* Other names: FDG;Drug: 18F-AV1451<br>* 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.<br>* Other names: TAU;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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. | 2 years | 
| Parametric Imaging | Metabolic rate of 18F-FDG measured from dynamic PET images | 2 years | 
| Map Reconstruction | Confirm that maximum a posteriori reconstructed PET images are diagnostically acceptable | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain Imaging, Whole Body Imaging