Trial Outcomes & Findings for Clinical Evaluation Of MP26 Features in Adults (NCT NCT02927327)
NCT ID: NCT02927327
Last Updated: 2018-12-06
Results Overview
scored on a 5-pt Likert scale: 1. Unacceptable 2. Poor 3. Acceptable 4. Good 5. Excellent
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
through study completion, an average of 2 months
Results posted on
2018-12-06
Participant Flow
Participant milestones
| Measure |
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
|
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)
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PET/MR ZTE MRAC
n=30 Participants
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
|
PET/MR Q Static (Q. MRAC)
n=31 Participants
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)
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=30 Participants
|
11 Participants
n=31 Participants
|
28 Participants
n=61 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=30 Participants
|
20 Participants
n=31 Participants
|
33 Participants
n=61 Participants
|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 12.86 • n=30 Participants
|
67.3 years
STANDARD_DEVIATION 10.76 • n=31 Participants
|
64.0 years
STANDARD_DEVIATION 12.21 • n=61 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=30 Participants
|
14 Participants
n=31 Participants
|
26 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=30 Participants
|
17 Participants
n=31 Participants
|
35 Participants
n=61 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
30 Participants
n=30 Participants
|
31 Participants
n=31 Participants
|
61 Participants
n=61 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 2 monthsPopulation: Subjects that had a clinical indication for PET/CT or PET/MR with radiotracer injection prescribed for their medical care outside of the study.
scored on a 5-pt Likert scale: 1. Unacceptable 2. Poor 3. Acceptable 4. Good 5. Excellent
Outcome measures
| Measure |
PET/MR ZTE MRAC
n=30 Participants
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
|
PET/MR Q Static (Q. MRAC)
n=31 Participants
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)
|
|---|---|---|
|
Diagnostic Image Quality
|
4.4 scores on a scale
Standard Deviation 0.54
|
3.9 scores on a scale
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: through study completion, an average of 2 monthsPopulation: Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study.
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.
Outcome measures
| Measure |
PET/MR ZTE MRAC
n=30 Participants
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
|
PET/MR Q Static (Q. MRAC)
n=31 Participants
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)
|
|---|---|---|
|
Determination of Diagnostic Acceptability
|
30 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: through study completion, an average of 2 monthsEase 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.
Outcome measures
| Measure |
PET/MR ZTE MRAC
n=30 Participants
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
|
PET/MR Q Static (Q. MRAC)
n=31 Participants
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)
|
|---|---|---|
|
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
|
4.6 scores on a scale
Standard Deviation 0.73
|
|
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
|
4.6 scores on a scale
Standard Deviation 0.73
|
|
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
|
4.6 scores on a scale
Standard Deviation 0.81
|
|
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
|
4.6 scores on a scale
Standard Deviation 0.73
|
|
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
|
4.6 scores on a scale
Standard Deviation 0.78
|
|
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
|
4.6 scores on a scale
Standard Deviation 0.85
|
SECONDARY outcome
Timeframe: through study completion, an average of 2 monthsPopulation: 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).
The number of participants reporting "yes" on a binary performance scale (Y/N) were collected.
Outcome measures
| Measure |
PET/MR ZTE MRAC
n=30 Participants
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
|
PET/MR Q Static (Q. MRAC)
n=31 Participants
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)
|
|---|---|---|
|
Number of Participants Reporting "Yes" On All Binary Performance Scale Questions
|
30 Participants
|
31 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: through study completion, an average of 2 monthsNumber of safety events (AEs and SAEs).
Outcome measures
Outcome data not reported
Adverse Events
PET/MR ZTE MRAC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PET/MR Q Static (Q. MRAC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place