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Clinical Evaluation Of MP26 Features in Adults

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ClinicalTrials.gov Identifier: NCT02927327
Recruitment Status : Completed
First Posted : October 7, 2016
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Brain Imaging
Whole Body Imaging
Interventions Device: Zero Echo Time (ZTE) scan for head attenuation
Device: Q.Static (Q. MRAC) for respiratory motion correction
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PET/MR ZTE MRAC PET/MR Q Static (Q. MRAC)
Hide Arm/Group Description

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

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)

Period Title: Overall Study
Started 30 31
Completed 30 31
Not Completed 0 0
Arm/Group Title PET/MR ZTE MRAC PET/MR Q Static (Q. MRAC) Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 30 31 61
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  56.7%
11
  35.5%
28
  45.9%
>=65 years
13
  43.3%
20
  64.5%
33
  54.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 31 participants 61 participants
60.6  (12.86) 67.3  (10.76) 64.0  (12.21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 31 participants 61 participants
Female
12
  40.0%
14
  45.2%
26
  42.6%
Male
18
  60.0%
17
  54.8%
35
  57.4%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 30 participants 31 participants 61 participants
30
 100.0%
31
 100.0%
61
 100.0%
1.Primary Outcome
Title Diagnostic Image Quality
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title PET/MR ZTE MRAC PET/MR Q Static (Q. MRAC)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 30 31
Mean (Standard Deviation)
Unit of Measure: scores on a scale
4.4  (0.54) 3.9  (0.68)
2.Secondary Outcome
Title Determination of Diagnostic Acceptability
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Diagnostic acceptability in the form of binary responses (Y/N) were collected from 61 subjects who completed the study.
Arm/Group Title PET/MR ZTE MRAC PET/MR Q Static (Q. MRAC)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 30 31
Measure Type: Count of Participants
Unit of Measure: Participants
30
 100.0%
31
 100.0%
3.Secondary Outcome
Title Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PET/MR ZTE MRAC PET/MR Q Static (Q. MRAC)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 30 31
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Prescribing PET scan 4.6  (0.73) 4.6  (0.73)
Prescribing MR scans simultaneous with PET 4.6  (0.73) 4.6  (0.73)
Starting and monitoring scanning 4.6  (0.81) 4.6  (0.81)
Reviewing PET and MR images 4.6  (0.73) 4.6  (0.73)
Overall process of doing this exam 4.6  (0.78) 4.6  (0.78)
Performing exam within acceptable duration to meet 4.6  (0.85) 4.6  (0.85)
4.Secondary Outcome
Title Number of Participants Reporting "Yes" On All Binary Performance Scale Questions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title PET/MR ZTE MRAC PET/MR Q Static (Q. MRAC)
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 30 31
Measure Type: Count of Participants
Unit of Measure: Participants
30
 100.0%
31
 100.0%
5.Other Pre-specified Outcome
Title Summary of Safety Information
Hide Description Number of safety events (AEs and SAEs).
Time Frame through study completion, an average of 2 months
Outcome Measure Data Not Reported
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PET/MR ZTE MRAC PET/MR Q Static (Q. MRAC)
Hide Arm/Group Description

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

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)

All-Cause Mortality
PET/MR ZTE MRAC PET/MR Q Static (Q. MRAC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/31 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
PET/MR ZTE MRAC PET/MR Q Static (Q. MRAC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PET/MR ZTE MRAC PET/MR Q Static (Q. MRAC)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/31 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John Strohmeyer
Organization: GE Healthcare
Phone: 609-865-7423
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02927327     History of Changes
Other Study ID Numbers: 114.03-2016-GES-0001
First Submitted: October 4, 2016
First Posted: October 7, 2016
Results First Submitted: July 26, 2018
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018