Gated and Non-Gated Dynamic PET/CT Imaging

An Exploration of Gated and Non-Gated Dynamic PET/CT Imaging

The goal of this study is to see how the images collected during the first hour compare with the routine images collected as part of the clinical scan.

Study Overview

• Status: Recruiting
• Conditions: Dynamic PET/CT Imaging
• Intervention / Treatment: Device: Dynamic PET/CT Imaging

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Richard L Wahl, M.D.; Phone Number: 314-362-7100; Email: rwahl@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Tyler J Fraum, M.D.
      • Contact: Richard L Wahl, M.D.; Phone Number: 314-362-7100; Email: rwahl@wustl.edu
      • Principal Investigator: Richard L Wahl, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria Main Cohort:

• 18 years of age or older
• Scheduled to undergo a clinical PET/CT scan with any clinically prescribed radiotracer for known or suspected malignancy (pathologic confirmation not required)
• Able to provide informed consent

Inclusion Criteria Repeatability Cohort:

• 18 years of age or older
• Scheduled to undergo a clinical PET/CT FDG or 68Ga- DOTA-0-Tyr3-Octreotate (DOTATATE) for known or suspected malignancy (pathologic confirmation not required)
• Able to provide informed consent

Exclusion Criteria:

-Younger than 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dynamic PET Imaging; Dynamic PET/CT imaging will begin at approximately the same time as the clinically prescribed radiotracer injection and will continue until approximately the start of the clinical scan; A subset of patients (up to 30 scheduled to undergo FDG or DOTATATE PET/CT imaging) will be asked to return within 7 days for a repeat imaging study.	Device: Dynamic PET/CT Imaging; -Will take approximately 60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of rapid, whole-body dynamic PET imaging as measured by number of participants who successfully complete the study imaging component	-Successful completion of the study imaging component will be defined as: (1) patient remains on scanner for the full dynamic phase of PET imaging prior to the standard of care PET/CT and (2) automated scanner software is able to successfully generate valid parametric maps (requires at least three consecutive whole-body PET acquisitions without substantial motion between acquisitions).	Completion of imaging for all participants enrolled in the study (estimated to be 4 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative impacts of data motion correction (OncoFreeze) as measured by semi-quantitative standardized uptake value (SUV) metrics	Will be assessed by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images.; OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise.; Two independent readers blinded to the reconstruction approach will score image quality utilizing a standard Likert-type scale and will extract quantitative metrics for any apparent FDG-avid lesions.	At the time of scan (Day 1)
Clinical impacts of data motion correction (OncoFreeze) as measured by number of detectable lesions	Will be assessed by comparing motion-corrected images derived from OncoFreeze with standard static non-gated PET images and conventionally gated PET images.; OncoFreeze is a novel approach to PET motion correction that utilizes 100% of events, which are corrected to an optimal gate image utilizing an optical flow algorithm, creating the potential for motion corrected images without increasing image noise.	At the time of scan (Day 1)
Repeatability of dynamic imaging as measured by calculating the measurement agreement in semi-quantitative PET metrics between test and retest dynamic images	-Imaging metric agreement will be measured using Bland-Altman analysis. Groupwise differences between imaging time-points will also be assessed using t-tests or Mann-Whitney U tests, depending on normality.	Day 1 and approximately 1 week later
Metabolic rate of images	-Will help to determine the optimal post-injection time period for dynamic PET imaging for Patlak analysis.	At the time of scan (Day 1)
Volume of distribution (intercept) images	-Will help to determine the optimal post-injection time period for dynamic PET imaging for Patlak analysis.	At the time of scan (Day 1)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Siemens Corporation, Corporate Technology
• Investigators: Principal Investigator: Richard L Wahl, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Actual): April 10, 2023
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 201910076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators may share your images with other researchers. They may be doing research in areas similar to this research or in other unrelated areas. These researchers may be at Washington University, at other research centers and institutions, or industry sponsors of research. The investigators may also share your research data with large data repositories (a repository is a database of information) for broad sharing with the research community. If the individual research data is placed in one of these repositories only qualified researchers, who have received prior approval from individuals that monitor the use of the data, will be able to look at the information.
• IPD Sharing Time Frame: Beginning 3 months and ending 10 years following article publication.
• IPD Sharing Access Criteria: Proposals should be directly submitted to rwahl@wustl.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No