Gated and Non-Gated Dynamic PET/CT Imaging

Study Overview
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Brief Summary
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The goal of this study is to see how the images collected during the first hour compare with the routine images collected as part of the clinical scan.

Official Title
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An Exploration of Gated and Non-Gated Dynamic PET/CT Imaging

Conditions
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Dynamic PET/CT Imaging

Intervention / Treatment
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* Device: Dynamic PET/CT Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Main Cohort: 18 years of age or older Scheduled to undergo a clinical PET/CT scan with any clinically prescribed radiotracer for known or suspected malignancy (pathologic confirmation not required) Able to provide informed consent Inclusion Criteria Repeatability Cohort: 18 years of age or older Scheduled to undergo a clinical PET/CT FDG or 68Ga- DOTA-0-Tyr3-Octreotate (DOTATATE) for known or suspected malignancy (pathologic confirmation not required) Able to provide informed consent Exclusion Criteria: -Younger than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Main Cohort: Dynamic PET Imaging<br>-Dynamic PET/CT imaging will begin at approximately the same time as the clinically prescribed radiotracer injection and will continue until approximately the start of the clinical scan | Device: Dynamic PET/CT Imaging<br>* -Will take approximately 60 minutes<br>|
| Experimental: Repeatability Cohort: Dynamic PET Imaging<br>Dynamic PET/CT imaging will begin at approximately the same time as the FDG or DOTATATE injection and will continue until approximately the start of the clinical scan A subset of patients (up to 30 scheduled to undergo FDG or DOTATATE PET/CT imaging) will be asked to return within 7 days for a repeat imaging study. | Device: Dynamic PET/CT Imaging<br>* -Will take approximately 60 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of rapid, whole-body dynamic PET imaging as measured by number of participants who successfully complete the study imaging component | -Successful completion of the study imaging component will be defined as: (1) patient remains on scanner for the full dynamic phase of PET imaging prior to the standard of care PET/CT and (2) automated scanner software is able to successfully generate valid parametric maps (requires at least three consecutive whole-body PET acquisitions without substantial motion between acquisitions). | Completion of imaging for all participants enrolled in the study (estimated to be 4 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative impacts of data motion correction (OncoFreeze) as measured by semi-quantitative standardized uptake value (SUV) metrics | Will be assessed by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise. Two independent readers blinded to the reconstruction approach will score image quality utilizing a standard Likert-type scale and will extract quantitative metrics for any apparent FDG-avid lesions. | At the time of scan (Day 1) | 
| Clinical impacts of data motion correction (OncoFreeze) as measured by number of detectable lesions | Will be assessed by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images. OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise. | At the time of scan (Day 1) | 
| Repeatability of dynamic imaging as measured by calculating the measurement agreement in semi-quantitative PET metrics between test and retest dynamic images | -Imaging metric agreement will be measured using Bland-Altman analysis. Groupwise differences between imaging time-points will also be assessed using t-tests or Mann-Whitney U tests, depending on normality. | Day 1 and approximately 1 week later | 
| Metabolic rate of images | -Will help to determine the optimal post-injection time period for dynamic PET imaging for Patlak analysis. | At the time of scan (Day 1) | 
| Volume of distribution (intercept) images | -Will help to determine the optimal post-injection time period for dynamic PET imaging for Patlak analysis. | At the time of scan (Day 1) |