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Gated and Non-Gated Dynamic PET/CT Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04283552
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
Siemens Corporation, Corporate Technology
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dynamic PET/CT Imaging Device: Dynamic PET/CT Imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Exploration of Gated and Non-Gated Dynamic PET/CT Imaging
Actual Study Start Date : May 29, 2020
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dynamic FDG Imaging
-Dynamic PET/CT imaging will begin at approximately the same time as the FDG injection and will continue until approximately the start of the clinical scan
Device: Dynamic PET/CT Imaging
-Will take approximately 60 minutes




Primary Outcome Measures :
  1. Feasibility of rapid, whole-body dynamic PET imaging as measured by number of participants who successfully complete the study imaging component [ Time Frame: Completion of imaging for all participants enrolled in the study (estimated to be 3 years) ]
    -Successful completion of the study imaging component will be defined as: (1) patient remains on scanner for at least 60 minutes of dynamic PET imaging 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Scheduled to undergo a clinical PET/CT who is at least suspected of having cancer (pathologic confirmation not required)
  • Able to provide informed consent

Exclusion Criteria:

-Younger than 18 years of age


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283552


Contacts
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Contact: Richard L Wahl, M.D. 314-362-7100 rwahl@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Richard L Wahl, M.D.    314-362-7100    rwahl@wustl.edu   
Principal Investigator: Richard L Wahl, M.D.         
Sub-Investigator: Tyler J Fraum, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Siemens Corporation, Corporate Technology
Investigators
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Principal Investigator: Richard L Wahl, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04283552    
Other Study ID Numbers: 201910076
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Beginning 3 months and ending 10 years following article publication.
Access Criteria: Proposals should be directly submitted to rwahl@wustl.edu.

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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