Clinical trial NCT04417998: Improving PET Image Quality and Quantification by Using Motion Correction, Parametric Imaging and MAP Reconstruction
Official title: Improving PET Image Quality and Quantification by Using Motion Correction, Parametric Imaging and MAP Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Imaging
Whole Body Imaging
Keywords: Brain Imaging
Whole Body Imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Motion Correction
timeFrame: 2 years
measure: Parametric Imaging
timeFrame: 2 years
measure: Map Reconstruction
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bradley Kemp, PhD
role: PRINCIPAL_INVESTIGATOR
References: