Clinical Evaluation Of MP26 Features in Adults

• Sponsor: GE Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02927327
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 2
• Duration (Months): 10.6
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Imaging; Whole Body Imaging	Device: Zero Echo Time (ZTE) scan for head attenuation; Device: Q.Static (Q. MRAC) for respiratory motion correction	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Clinical Evaluation Of MP26 Features in Adults
• Study Start Date: Nov 1, 2016
• Actual Primary Completion Date: Sep 20, 2017
• Actual Study Completion Date: Sep 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Device: 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
Experimental: 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)	Device: 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)

Outcome Measures

Primary Outcome Measures

1. Diagnostic Image Quality [through study completion, an average of 2 months]

   scored on a 5-pt Likert scale: Unacceptable Poor Acceptable Good Excellent

Secondary Outcome Measures

1. 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.

2. 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.

3. 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 Outcome Measures

1. Summary of Safety Information [through study completion, an average of 2 months]

   Number of safety events (AEs and SAEs).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• GE Healthcare

Investigators

• Study Director: Tibor Duliskovich, M.D., GE Healthcare, Medical Monitor

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 30, 2016

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT02927327
• Other Study ID Numbers: 114.03-2016-GES-0001
• First Posted: Oct 7, 2016
• Last Update Posted: Dec 6, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Arm/Group Title	PET/MR ZTE MRAC	PET/MR Q Static (Q. MRAC)
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

Baseline Characteristics

Arm/Group Title	PET/MR ZTE MRAC	PET/MR Q Static (Q. MRAC)	Total
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 Participants	30	31	61
Age (Count of Participants)
<=18 years	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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.6 (12.86)	67.3 (10.76)	64.0 (12.21)
Sex: Female, Male (Count of Participants)
Female	12 40%	14 45.2%	26 42.6%
Male	18 60%	17 54.8%	35 57.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	30 100%	31 100%	61 100%

Outcome Measures

1. Primary Outcome

Title	Diagnostic Image Quality
Description	scored on a 5-pt Likert scale: Unacceptable Poor Acceptable Good Excellent
Time Frame	through study completion, an average of 2 months

Outcome Measure Data

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)
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)
Measure Participants	30	31
Mean (Standard Deviation) [scores on a scale]	4.4 (0.54)	3.9 (0.68)

2. Secondary Outcome

Title	Determination of Diagnostic Acceptability
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

Outcome Measure Data

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)
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)
Measure Participants	30	31
Count of Participants [Participants]	30 100%	31 100%

3. Secondary Outcome

Title	Ease of Use Per Procedure Rated on a 5-pt Likert Scale Score
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PET/MR ZTE MRAC	PET/MR Q Static (Q. MRAC)
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)
Measure Participants	30	31
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
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

Outcome Measure Data

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)
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)
Measure Participants	30	31
Count of Participants [Participants]	30 100%	31 100%

5. Other Pre-specified Outcome

Title	Summary of Safety Information
Description	Number of safety events (AEs and SAEs).
Time Frame	through study completion, an average of 2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

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.
Arm/Group Title	PET/MR ZTE MRAC		PET/MR Q Static (Q. MRAC)
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/31 (0%)
Serious Adverse Events
	PET/MR ZTE MRAC		PET/MR Q Static (Q. MRAC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	PET/MR ZTE MRAC		PET/MR Q Static (Q. MRAC)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.