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

NCT04417998 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 19-010591
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Imaging; Whole Body Imaging

Keywords

Brain Imaging; Whole Body Imaging

Outcome Measures

Primary Outcomes (3)

• 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. 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 years

• Parametric Imaging

  Metabolic rate of 18F-FDG measured from dynamic PET images. Uptake rate constant Ki in the grey matter of the brain.

  2 years

• Map Reconstruction

  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.

  2 years

Study Arms (2)

Motion Correction

ACTIVE COMPARATOR

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.

Device: Siemens E7 Reconstruction Tool

Parametric Imaging

ACTIVE COMPARATOR

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.

Drug: 18F-FDG; Drug: 18F-AV1451

Interventions

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.

Also known as: FDG

Parametric Imaging

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.

Also known as: TAU

Parametric Imaging

Siemens E7 Reconstruction Tool DEVICE

Software to correct for motion

Motion Correction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• SNMMI abstract on parametric imaging
• SNMMI abstract on brain motion correction

MeSH Terms

Interventions

Fluorodeoxyglucose F18; 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Results Point of Contact

• Title: Bradley J. Kemp, Ph.D.
• Organization: Mayo Clinic

Kemp.Brad@mayo.edu

507-284-4399

Study Officials

• Bradley Kemp, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: June 5, 2020
• Study Start: June 3, 2020
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: January 22, 2025
• Results First Posted: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)