Dynamic PET/CT Imaging Clinical Trial
Official title:
An Exploration of Gated and Non-Gated Dynamic PET/CT Imaging
| NCT number | NCT04283552 |
| Other study ID # | 201910076 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | May 29, 2020 |
| Est. completion date | April 10, 2023 |
| Verified date | May 2024 |
| Source | Washington University School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 80 |
| Est. completion date | April 10, 2023 |
| Est. primary completion date | April 10, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Washington University School of Medicine | Siemens Corporation, Corporate Technology |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max | 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) | |
| Secondary | Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs) | 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) | |
| Secondary | Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate | 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) | |
| Secondary | 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 | 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) | |
| Secondary | 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 | 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) | |
| Secondary | 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 | 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) | |
| Secondary | 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 | 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) | |
| Secondary | 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 | 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) | |
| Secondary | Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images | 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 %?] |
Day 1 and approximately 1 week later | |
| Secondary | Metabolic Rate of Images | -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) | |
| Secondary | 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) |