Trial Outcomes & Findings for Gated and Non-Gated Dynamic PET/CT Imaging (NCT NCT04283552)
NCT ID: NCT04283552
Last Updated: 2024-05-20
Results Overview
-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).
TERMINATED
NA
80 participants
At time of scan (day 1)
2024-05-20
Participant Flow
Participant milestones
| Measure |
Dynamic PET Imaging
* 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.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gated and Non-Gated Dynamic PET/CT Imaging
Baseline characteristics by cohort
| Measure |
Dynamic PET Imaging
n=80 Participants
* 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.
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At time of scan (day 1)-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).
Outcome measures
| Measure |
Dynamic PET Imaging
n=80 Participants
* 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.
|
Dynamic PET/CT Belt-Gating Optimal Gate
* 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.
|
|---|---|---|
|
Feasibility of Rapid, Whole-body Dynamic PET Imaging as Measured by Number of Participants Who Successfully Completed the Study Imaging Component
|
80 Participants
|
—
|
SECONDARY outcome
Timeframe: At the time of scan (Day 1)Population: This outcome measure requires subjects to have disease so only 36 subjects had disease.
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.
Outcome measures
| Measure |
Dynamic PET Imaging
n=36 Participants
* 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.
|
Dynamic PET/CT Belt-Gating Optimal Gate
* 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.
|
|---|---|---|
|
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max
Belt-gating optimal gate
|
10.77 SUV-max
Interval 6.21 to 18.46
|
—
|
|
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max
Elastic motion correction with blurring utilizing belt gating
|
10.75 SUV-max
Interval 5.86 to 18.7
|
—
|
|
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max
Elastic motion correction with blurring utilizing data-driven gating
|
10.74 SUV-max
Interval 6.04 to 18.66
|
—
|
|
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Semi-quantitative Standardized Uptake Value (SUV)-Max
Ungated
|
9.00 SUV-max
Interval 5.01 to 15.97
|
—
|
SECONDARY outcome
Timeframe: At the time of scan (Day 1)Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
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.
Outcome measures
| Measure |
Dynamic PET Imaging
n=36 Participants
* 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.
|
Dynamic PET/CT Belt-Gating Optimal Gate
* 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.
|
|---|---|---|
|
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs)
Belt-gating optimal gate
|
6.31 contrast-to-noise ratio
Interval 3.97 to 12.08
|
—
|
|
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs)
Elastic motion correction with blurring utilizing belt gating
|
9.14 contrast-to-noise ratio
Interval 5.59 to 15.87
|
—
|
|
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs)
Elastic motion correction with blurring utilizing data-driven gating
|
8.89 contrast-to-noise ratio
Interval 5.5 to 17.05
|
—
|
|
Quantitative Impacts of Data Motion Correction (OncoFreeze) as Measured by Lesion Contrast-to-noise Ratios (CNRs)
Ungated
|
7.89 contrast-to-noise ratio
Interval 4.99 to 15.17
|
—
|
SECONDARY outcome
Timeframe: At the time of scan (Day 1)Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
* 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.
Outcome measures
| Measure |
Dynamic PET Imaging
n=36 Participants
* 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.
|
Dynamic PET/CT Belt-Gating Optimal Gate
n=36 Participants
* 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.
|
|---|---|---|
|
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate
Reader 1
|
1.11 relative lesions
Interval 0.0 to 9.0
|
0.14 relative lesions
Interval 0.0 to 9.0
|
|
Clinical Impacts of Data Motion Correction (OncoFreeze) as Measured by Mean Relative Lesion Number Between Ungated and Belt-gating Optimal Gate
Reader 2
|
0.31 relative lesions
Interval 0.0 to 2.0
|
0.14 relative lesions
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: At the time of scan (Day 1)Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
* 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.
Outcome measures
| Measure |
Dynamic PET Imaging
n=36 Participants
* 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.
|
Dynamic PET/CT Belt-Gating Optimal Gate
n=36 Participants
* 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.
|
|---|---|---|
|
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
Reader 1
|
1.11 mean relative lesion number
Interval 0.0 to 9.0
|
1.28 mean relative lesion number
Interval 0.0 to 9.0
|
|
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
Reader 2
|
0.31 mean relative lesion number
Interval 0.0 to 2.0
|
0.50 mean relative lesion number
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: At the time of scan (Day 1)Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
* 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.
Outcome measures
| Measure |
Dynamic PET Imaging
n=36 Participants
* 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.
|
Dynamic PET/CT Belt-Gating Optimal Gate
n=36 Participants
* 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.
|
|---|---|---|
|
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
Reader 1
|
1.11 mean relative lesion number
Interval 0.0 to 9.0
|
1.47 mean relative lesion number
Interval 0.0 to 9.0
|
|
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
Reader 2
|
0.31 mean relative lesion number
Interval 0.0 to 2.0
|
0.50 mean relative lesion number
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: At the time of scan (Day 1)Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
* 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.
Outcome measures
| Measure |
Dynamic PET Imaging
n=36 Participants
* 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.
|
Dynamic PET/CT Belt-Gating Optimal Gate
n=36 Participants
* 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.
|
|---|---|---|
|
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
Reader 1
|
0.14 mean relative lesion number
Interval 0.0 to 1.0
|
1.28 mean relative lesion number
Interval 0.0 to 9.0
|
|
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
Reader 2
|
0.14 mean relative lesion number
Interval 0.0 to 2.0
|
0.50 mean relative lesion number
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: At the time of scan (Day 1)Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
* 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.
Outcome measures
| Measure |
Dynamic PET Imaging
n=36 Participants
* 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.
|
Dynamic PET/CT Belt-Gating Optimal Gate
n=36 Participants
* 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.
|
|---|---|---|
|
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
Reader 1
|
0.14 mean relative lesion number
Interval 0.0 to 1.0
|
1.47 mean relative lesion number
Interval 0.0 to 9.0
|
|
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
Reader 2
|
0.14 mean relative lesion number
Interval 0.0 to 2.0
|
0.50 mean relative lesion number
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: At the time of scan (Day 1)Population: This outcome measure required subjects to have cancer so only 36 subjects had sufficient cancer in order to be analyzed.
* 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.
Outcome measures
| Measure |
Dynamic PET Imaging
n=36 Participants
* 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.
|
Dynamic PET/CT Belt-Gating Optimal Gate
n=36 Participants
* 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.
|
|---|---|---|
|
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
Reader 1
|
1.28 mean relative lesion number
Interval 0.0 to 9.0
|
1.47 mean relative lesion number
Interval 0.0 to 9.0
|
|
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
Reader 2
|
0.50 mean relative lesion number
Interval 0.0 to 2.0
|
1.47 mean relative lesion number
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Day 1 and approximately 1 week laterPopulation: Only 9 subjects completed the test-retest protocol and of those only 4 subjects had \[18F\]FDG-avid lesions.
* 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 \[T-RT %Δ\]
Outcome measures
| Measure |
Dynamic PET Imaging
n=4 Participants
* 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.
|
Dynamic PET/CT Belt-Gating Optimal Gate
* 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.
|
|---|---|---|
|
Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
SUV-peak
|
26 test-retest percent changes
Interval -22.0 to 75.0
|
—
|
|
Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
cSUV-max
|
-6 test-retest percent changes
Interval -53.0 to 41.0
|
—
|
|
Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
cSUV-peak
|
-27 test-retest percent changes
Interval -77.0 to 23.0
|
—
|
|
Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
SUR-max
|
81 test-retest percent changes
Interval 48.0 to 114.0
|
—
|
|
Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
PS-max
|
11 test-retest percent changes
Interval -32.0 to 54.0
|
—
|
|
Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
PS-peak
|
15 test-retest percent changes
Interval -30.0 to 59.0
|
—
|
|
Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
SUV-max
|
47 test-retest percent changes
Interval 3.0 to 91.0
|
—
|
|
Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
SUR-peak
|
63 test-retest percent changes
Interval 23.0 to 102.0
|
—
|
|
Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
cSUR-max
|
7 test-retest percent changes
Interval -33.0 to 48.0
|
—
|
|
Repeatability of Dynamic Imaging as Measured by Calculating the Measurement Agreement in Semi-quantitative PET Metrics Between Test and Retest Dynamic Images
cSUR-peak
|
-14 test-retest percent changes
Interval -60.0 to 33.0
|
—
|
SECONDARY outcome
Timeframe: At the time of scan (Day 1)Population: This outcome measure required subjects to have cancer so only 41 subjects had sufficient cancer in order to be analyzed.
-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.
Outcome measures
| Measure |
Dynamic PET Imaging
n=41 Participants
* 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.
|
Dynamic PET/CT Belt-Gating Optimal Gate
* 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.
|
|---|---|---|
|
Metabolic Rate of Images
PS-Early Reader 1
|
1.19 score on a scale
Interval 1.0 to 2.0
|
—
|
|
Metabolic Rate of Images
PS-Late Reader 1
|
3.95 score on a scale
Interval 3.0 to 4.0
|
—
|
|
Metabolic Rate of Images
PS-Early Reader 2
|
2.14 score on a scale
Interval 1.0 to 4.0
|
—
|
|
Metabolic Rate of Images
PS-Late Reader 2
|
3.95 score on a scale
Interval 3.0 to 4.0
|
—
|
SECONDARY outcome
Timeframe: At the time of scan (Day 1)Population: The intercept images were unacceptable due to high quantitative biases and noise levels.
-Will help to determine the optimal post-injection time period for dynamic PET imaging for Patlak analysis.
Outcome measures
Outcome data not reported
Adverse Events
Dynamic PET Imaging
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dynamic PET Imaging
n=80 participants at risk
* 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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
1.2%
1/80 • Adverse events and all-cause mortality were collected on the day of the PET/CT.
|
Additional Information
Richard L. Wahl, M.D.
Washington University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place