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

Brain Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04417998
• Other study ID #: 19-010591
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: June 3, 2020
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Imaging
• Whole Body Imaging

Intervention

Drug:
• 18F-FDG
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.
• 18F-AV1451
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.

Device:
• Siemens E7 Reconstruction Tool
Software to correct for motion

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Parametric Imaging	Metabolic rate of 18F-FDG measured from dynamic PET images	2 years
Primary	Map Reconstruction	Confirm that maximum a posteriori reconstructed PET images are diagnostically acceptable	2 years