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OpenTrials
Completed

NCT Number: NCT04417998

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: FDG

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.

Other names: TAU

Siemens E7 Reconstruction Tool

Device

Software to correct for motion

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 5, 2020
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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