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Clinical Trials/NCT04417998
NCT04417998
Completed
Phase 4

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

Mayo Clinic1 site in 1 country80 target enrollmentJune 3, 2020

Overview

Phase
Phase 4
Intervention
Siemens E7 Reconstruction Tool
Conditions
Brain Imaging
Sponsor
Mayo Clinic
Enrollment
80
Locations
1
Primary Endpoint
Motion Correction
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
June 3, 2020
End Date
December 20, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bradley Kemp

Principal Investigator

Mayo Clinic

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

Arms & Interventions

Motion Correction

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.

Intervention: Siemens E7 Reconstruction Tool

Parametric Imaging

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.

Intervention: 18F-FDG

Parametric Imaging

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.

Intervention: 18F-AV1451

Outcomes

Primary Outcomes

Motion Correction

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Study Sites (1)

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