Brain Imaging, Whole Body Imaging
Conditions
Brief summary
The purpose of the study is to collect representative clinical images (head and whole-body scans) of demonstrated diagnostic quality using the next-generation SIGNA PET/MR device equipped with investigational software components in adult population. The images and summary data from this study are intended for use in regulatory submission.
Detailed description
Primary Objective: To demonstrate diagnostic image quality of image sets with ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR in representative clinical cases of the general imaging population. Secondary Objective(s): To verify diagnostic acceptability, ease of use, and functionality of ZTE MRAC and Q Static (Q. MRAC) for SIGNA PET/MR at clinical sites. Safety Objective(s): To collect information about safety events and device issues.
Interventions
DEVICEZero Echo Time (ZTE) scan for head attenuation
The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR. PET/MR ZTE MRAC
DEVICEQ.Static (Q. MRAC) for respiratory motion correction
An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images. PET/MR Q Static (Q. MRAC)
Sponsors
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Are adults (aged 18 or older); 2. Have preexisting clinical indication for PET/CT or PET/MR with radiotracer injection (for subjects that will undergo ZTE procedures, a preexisting clinical indication for PET/CT is required); 3. Are able to undergo PET/MR within the tracer validity time frame after radiotracer injection; 4. Can hear without assistive devices and have necessary mental capacity to follow study instructions; 5. Are willing and able to provide written informed consent; 6. Are considered eligible for MRI and PET exams, according to site institutional safety policies.
Exclusion criteria
1. Were previously enrolled in the study; 2. If female, are pregnant or of undetermined pregnancy status; 3. Cannot fit safely in the device (\>55 cm axial diameter or \>227 kgs body weight); 4. Have implants or attached medical devices that could be unsafe for MRI; 5. Have medical conditions or require urgent care that could make it unsafe to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Image Quality | through study completion, an average of 2 months | scored on a 5-pt Likert scale: 1. Unacceptable 2. Poor 3. Acceptable 4. Good 5. Excellent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of Diagnostic Acceptability | through study completion, an average of 2 months | Site level determination of diagnostic acceptability (Y/N) based on consensus between radiologist(s) and nuclear medicine physician(s) at the site. Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study. |
| Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | through study completion, an average of 2 months | Ease of use ratings, based on a 5-point Likert scale (e.g. 1=unacceptable, 2=poor, 3=acceptable, 4=good, 5=excellent), were collected from the population of subjects who completed the study. |
| Number of Participants Reporting Yes On All Binary Performance Scale Questions | through study completion, an average of 2 months | The number of participants reporting yes on a binary performance scale (Y/N) were collected. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Summary of Safety Information | through study completion, an average of 2 months | Number of safety events (AEs and SAEs). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PET/MR ZTE MRAC PET/MR zero echo time (ZTE) scan for head attenuation and Q.Static . PET/MR ZTE MRAC images to be acquired for post-processing and reader assessment.
Zero Echo Time (ZTE) scan for head attenuation
Zero Echo Time (ZTE) scan for head attenuation: The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.
PET/MR ZTE MRAC | 30 |
| PET/MR Q Static (Q. MRAC) Q.Static (Q. MRAC) for respiratory motion correction. PET/MR Q Static (Q. MRAC) images to be acquired for post-processing and reader assessment.
PET/MR Q Static (Q. MRAC)
Q.Static (Q. MRAC) for respiratory motion correction: An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.
PET/MR Q Static (Q. MRAC) | 31 |
| Total | 61 |
Baseline characteristics
| Characteristic | Total | PET/MR ZTE MRAC | PET/MR Q Static (Q. MRAC) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 33 Participants | 13 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 17 Participants | 11 Participants |
| Age, Continuous | 64.0 years STANDARD_DEVIATION 12.21 | 60.6 years STANDARD_DEVIATION 12.86 | 67.3 years STANDARD_DEVIATION 10.76 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 61 Participants | 30 Participants | 31 Participants |
| Sex: Female, Male Female | 26 Participants | 12 Participants | 14 Participants |
| Sex: Female, Male Male | 35 Participants | 18 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 0 / 30 | 0 / 31 |
| serious Total, serious adverse events | 0 / 30 | 0 / 31 |
Outcome results
Primary
Diagnostic Image Quality
scored on a 5-pt Likert scale: 1. Unacceptable 2. Poor 3. Acceptable 4. Good 5. Excellent
Time frame: through study completion, an average of 2 months
Population: Subjects that had a clinical indication for PET/CT or PET/MR with radiotracer injection prescribed for their medical care outside of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PET/MR ZTE MRAC | Diagnostic Image Quality | 4.4 scores on a scale | Standard Deviation 0.54 |
| PET/MR Q Static (Q. MRAC) | Diagnostic Image Quality | 3.9 scores on a scale | Standard Deviation 0.68 |
Secondary
Determination of Diagnostic Acceptability
Site level determination of diagnostic acceptability (Y/N) based on consensus between radiologist(s) and nuclear medicine physician(s) at the site. Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study.
Time frame: through study completion, an average of 2 months
Population: Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PET/MR ZTE MRAC | Determination of Diagnostic Acceptability | 30 Participants |
| PET/MR Q Static (Q. MRAC) | Determination of Diagnostic Acceptability | 31 Participants |
Secondary
Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score
Ease of use ratings, based on a 5-point Likert scale (e.g. 1=unacceptable, 2=poor, 3=acceptable, 4=good, 5=excellent), were collected from the population of subjects who completed the study.
Time frame: through study completion, an average of 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PET/MR ZTE MRAC | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Prescribing MR scans simultaneous with PET | 4.6 scores on a scale | Standard Deviation 0.73 |
| PET/MR ZTE MRAC | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Reviewing PET and MR images | 4.6 scores on a scale | Standard Deviation 0.73 |
| PET/MR ZTE MRAC | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Prescribing PET scan | 4.6 scores on a scale | Standard Deviation 0.73 |
| PET/MR ZTE MRAC | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Overall process of doing this exam | 4.6 scores on a scale | Standard Deviation 0.78 |
| PET/MR ZTE MRAC | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Starting and monitoring scanning | 4.6 scores on a scale | Standard Deviation 0.81 |
| PET/MR ZTE MRAC | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Performing exam within acceptable duration to meet | 4.6 scores on a scale | Standard Deviation 0.85 |
| PET/MR Q Static (Q. MRAC) | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Performing exam within acceptable duration to meet | 4.6 scores on a scale | Standard Deviation 0.85 |
| PET/MR Q Static (Q. MRAC) | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Prescribing PET scan | 4.6 scores on a scale | Standard Deviation 0.73 |
| PET/MR Q Static (Q. MRAC) | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Prescribing MR scans simultaneous with PET | 4.6 scores on a scale | Standard Deviation 0.73 |
| PET/MR Q Static (Q. MRAC) | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Starting and monitoring scanning | 4.6 scores on a scale | Standard Deviation 0.81 |
| PET/MR Q Static (Q. MRAC) | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Reviewing PET and MR images | 4.6 scores on a scale | Standard Deviation 0.73 |
| PET/MR Q Static (Q. MRAC) | Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score | Overall process of doing this exam | 4.6 scores on a scale | Standard Deviation 0.78 |
Secondary
Number of Participants Reporting Yes On All Binary Performance Scale Questions
The number of participants reporting yes on a binary performance scale (Y/N) were collected.
Time frame: through study completion, an average of 2 months
Population: Functionality ratings, based on a binary performance scale (Y/N), were collected from the population of subjects who completed the study, including both ZTE and Q.Static populations (N=61 total subjects).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PET/MR ZTE MRAC | Number of Participants Reporting Yes On All Binary Performance Scale Questions | 30 Participants |
| PET/MR Q Static (Q. MRAC) | Number of Participants Reporting Yes On All Binary Performance Scale Questions | 31 Participants |
Other Pre-specified
Summary of Safety Information
Number of safety events (AEs and SAEs).
Time frame: through study completion, an average of 2 months