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Loss of funding
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| Name | Class |
|---|---|
| Siemens Corporation, Corporate Technology | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic PET Imaging | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic PET/CT Imaging | Device | -Will take approximately 60 minutes |
|
| 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 | -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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria Main Cohort:
Inclusion Criteria Repeatability Cohort:
Exclusion Criteria:
-Younger than 18 years of age
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Wahl, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39142828 | Derived | Ince S, Laforest R, Itani M, Prasad V, Derenoncourt PR, Crandall JP, Ashrafinia S, Smith AM, Wahl RL, Fraum TJ. Quantitative Assessments of Tumor Activity in a General Oncologic PET/CT Population: Which Metric Minimizes Tracer Uptake Time Dependence? J Nucl Med. 2024 Sep 3;65(9):1349-1356. doi: 10.2967/jnumed.123.266469. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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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.
Beginning 3 months and ending 10 years following article publication.
Proposals should be directly submitted to rwahl@wustl.edu.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dynamic PET Imaging |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dynamic PET Imaging |
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | At time of scan (day 1) |
|
Adverse events and all-cause mortality were collected on the day of the PET/CT.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dynamic PET Imaging |
|
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema multiforme | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard L. Wahl, M.D. | Washington University School of Medicine | 314-362-7100 | rwahl@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2020 | Mar 2, 2024 | Prot_SAP_000.pdf |
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| At the time of scan (Day 1) |
| 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) |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| Day 1 and approximately 1 week later |
| 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) |
| 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) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | This outcome measure requires subjects to have disease so only 36 subjects had disease. | Posted | Median | Inter-Quartile Range | SUV-max | 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. | This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed. | Posted | Median | Inter-Quartile Range | contrast-to-noise ratio | 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 |
| This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed. | Posted | Mean | Full Range | relative lesions | 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 |
| This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed. | Posted | Mean | Full Range | mean relative lesion number | 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 |
| This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed. | Posted | Mean | Full Range | mean relative lesion number | 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 |
| This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed. | Posted | Mean | Full Range | mean relative lesion number | 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 |
| This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed. | Posted | Mean | Full Range | mean relative lesion number | 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 |
| This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed. | Posted | Mean | Full Range | mean relative lesion number | 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 |
| Only 9 subjects completed the test-retest protocol and of those only 4 subjects had [18F]FDG-avid lesions. | Posted | Mean | 95% Confidence Interval | test-retest percent changes | 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. | This outcome measure required subjects to have cancer so only 41 subjects had sufficient cancer in order to be analyzed. | Posted | Mean | Full Range | score on a scale | 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. | The intercept images were unacceptable due to high quantitative biases and noise levels. | Posted | At the time of scan (Day 1) |
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 1 |
| 80 |
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|
| Ungated |
|
|
| Ungated |
|
| 0.28 |
| Superiority |
| >0.05 |
| Superiority |
| >0.05 |
| Superiority |
| 0.02 |
| Superiority |
| 0.02 |
| Superiority |
| Title | Measurements |
|---|---|
|
| SUV-peak |
|
| cSUV-max |
|
| cSUV-peak |
|
| SUR-max |
|
| SUR-peak |
|
| cSUR-max |
|
| cSUR-peak |
|
| Title | Measurements |
|---|---|
|
| PS-Late Reader 2 |
|
| <0.001 |
| Superiority |