Gated and Non-Gated Dynamic PET/CT Imaging

May 13, 2024 updated by: Washington University School of Medicine

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of Rapid, Whole-body Dynamic PET Imaging as Measured by Number of Participants Who Successfully Completed the Study Imaging Component
Time Frame: At time of scan (day 1)
-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).
At time of scan (day 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max
Time Frame: At the time of scan (Day 1)
Subjects underwent standard-of-care (SOC) PET acquisition with a respiratory-gating belt. Ungated (UG), belt-gating-derived optimal gate (BG-OG), EMCD utilizing belt gating (BG-EMCD), and EMCD utilizing data-driven gating (DDG-EMCD) images were reconstructed. Tracer-avid lesions in the lower chest or upper abdomen were segmented. Quantitative metrics were extracted.
At the time of scan (Day 1)
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs)
Time Frame: At the time of scan (Day 1)
Subjects underwent standard-of-care (SOC) PET acquisition with a respiratory-gating belt. Ungated (UG), belt-gating-derived optimal gate (BG-OG), EMCD utilizing belt gating (BG-EMCD), and EMCD utilizing data-driven gating (DDG-EMCD) images were reconstructed. Tracer-avid lesions in the lower chest or upper abdomen were segmented. Quantitative metrics were extracted.
At the time of scan (Day 1)
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate
Time Frame: At the time of scan (Day 1)
  • Will be assessed by Reader 1 and Reader 2 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)
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Belt Gating
Time Frame: At the time of scan (Day 1)
  • Will be assessed by Reader 1 and Reader 2 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)
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Elastic Motion Correction With Blurring Utilizing Data-driven Gating
Time Frame: At the time of scan (Day 1)
  • Will be assessed by Reader 1 and Reader 2 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)
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Belt Gating
Time Frame: At the time of scan (Day 1)
  • Will be assessed by Reader 1 and Reader 2 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)
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Belt-gating Optimal Gate and Elastic Motion Correction With Blurring Utilizing Data-driven Gating
Time Frame: At the time of scan (Day 1)
  • Will be assessed Reader 1 and Reader 2 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)
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Elastic Motion Correction With Blurring Utilizing Belt Gating and Elastic Motion Correction With Blurring Utilizing Data-driven Gating
Time Frame: At the time of scan (Day 1)
  • Will be assessed by Reader 1 and Reader 2 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
Time Frame: Day 1 and approximately 1 week later
  • Standardized uptake value (SUV)-max, SUV-peak, Uptake time-corrected SUV (cSUV), Standardized uptake ratio (SUR), Uptake time-corrected standardized uptake ratio (cSUR), Patlak slope (PS)-max, and PS-peak were analyzed.
  • Test-retest repeatability of quantitative metrics based on the PS versus the SUV among lesions and normal organs on oncologic [18F]FDG-PET/CT.
  • Repeatability was assessed via mean test-retest percent changes [T-RT %Δ]
Day 1 and approximately 1 week later
Metabolic Rate of Images
Time Frame: At the time of scan (Day 1)
-Will help to determine the optimal post-injection time period for dynamic PET imaging for Early (35-50 min post-injection) and Late (75-90 min post-injection) Patlak slope (PS) analysis. Reader 1 and Reader 2 used a standard Likert score from 0-4 with 1 being the worst and 4 being the best. A higher score indicated the image was easier to read.
At the time of scan (Day 1)
Volume of Distribution (Intercept) Images
Time Frame: At the time of scan (Day 1)
-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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Siemens Corporation, Corporate Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard L Wahl, M.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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