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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET/MR ZTE MRAC | Experimental | 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 |
|
| PET/MR Q Static (Q. MRAC) | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zero Echo Time (ZTE) scan for head attenuation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Image Quality | scored on a 5-pt Likert scale:
| through study completion, an average of 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Safety Information | Number of safety events (AEs and SAEs). | through study completion, an average of 2 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tibor Duliskovich, M.D. | GE Healthcare, Medical Monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Diagnostic Image Quality | scored on a 5-pt Likert scale:
| Subjects that had a clinical indication for PET/CT or PET/MR with radiotracer injection prescribed for their medical care outside of the study. | Posted | Mean | Standard Deviation | scores on a scale | through study completion, an average of 2 months |
|
Adverse Events were reported from the time the subject entered the PET/MR suite until the subject left the PET/MR suite, an average of less than 2 hours.
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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 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Strohmeyer | GE Healthcare | 609-865-7423 | john.strohmeyer@ge.com |
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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 | Aug 30, 2016 | Oct 25, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003947 | Diagnostic Techniques, Radioisotope |
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|
| Q.Static (Q. MRAC) for respiratory motion correction | Device | 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) |
|
| 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. | through study completion, an average of 2 months |
| 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. | through study completion, an average of 2 months |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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) |
|
|
| 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. | Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study. | Posted | Count of Participants | Participants | through study completion, an average of 2 months |
|
|
|
| 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. | Posted | Mean | Standard Deviation | scores on a scale | through study completion, an average of 2 months |
|
|
|
| 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. | 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). | Posted | Count of Participants | Participants | through study completion, an average of 2 months |
|
|
|
| Other Pre-specified | Summary of Safety Information | Number of safety events (AEs and SAEs). | Not Posted | through study completion, an average of 2 months | Participants |
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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) | 0 | 31 | 0 | 31 | 0 | 31 |
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| Starting and monitoring scanning |
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| Reviewing PET and MR images |
|
| Overall process of doing this exam |
|
| Performing exam within acceptable duration to meet |
|