Clinical trial NCT04283552: Gated and Non-Gated Dynamic PET/CT Imaging
Official title: An Exploration of Gated and Non-Gated Dynamic PET/CT Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dynamic PET/CT Imaging
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Siemens Corporation, Corporate Technology
First posted: 2020-02-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Rapid, Whole-body Dynamic PET Imaging as Measured by Number of Participants Who Successfully Completed the Study Imaging Component
timeFrame: At time of scan (day 1)
Secondary outcomes:
measure: Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max
timeFrame: At the time of scan (Day 1)
measure: Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs)
timeFrame: At the time of scan (Day 1)
measure: Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate
timeFrame: At the time of scan (Day 1)
measure: 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
timeFrame: At the time of scan (Day 1)
measure: 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
timeFrame: At the time of scan (Day 1)
measure: 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
timeFrame: At the time of scan (Day 1)
measure: 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
timeFrame: At the time of scan (Day 1)
measure: 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
timeFrame: At the time of scan (Day 1)
measure: Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
timeFrame: Day 1 and approximately 1 week later
measure: Metabolic Rate of Images
timeFrame: At the time of scan (Day 1)
measure: Volume of Distribution (Intercept) Images
timeFrame: At the time of scan (Day 1)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Richard L Wahl, M.D.
role: PRINCIPAL_INVESTIGATOR
References: