Study Stopped
Loss of funding
Gated and Non-Gated Dynamic PET/CT Imaging
An Exploration of Gated and Non-Gated Dynamic PET/CT Imaging
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedStudy Start
First participant enrolled
May 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 10, 2023
CompletedResults Posted
Study results publicly available
May 20, 2024
CompletedMay 20, 2024
May 1, 2024
2.9 years
February 20, 2020
April 9, 2024
May 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility of Rapid, Whole-body Dynamic PET Imaging as Measured by Number of Participants Who Successfully Completed 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).
At time of scan (day 1)
Secondary Outcomes (11)
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max
At the time of scan (Day 1)
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs)
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
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
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
At the time of scan (Day 1)
- +6 more secondary outcomes
Study Arms (1)
Dynamic PET Imaging
EXPERIMENTAL* 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- Younger than 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Related Links
Results Point of Contact
- Title
- Richard L. Wahl, M.D.
- Organization
- Washington University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Richard L Wahl, M.D.
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2020
First Posted
February 25, 2020
Study Start
May 29, 2020
Primary Completion
April 10, 2023
Study Completion
April 10, 2023
Last Updated
May 20, 2024
Results First Posted
May 20, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- Beginning 3 months and ending 10 years following article publication.
- Access Criteria
- Proposals should be directly submitted to rwahl@wustl.edu.
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.