Clinical Evaluation Of MP26 Features in Adults
Phase: NA
Conditions: Brain Imaging, Whole Body Imaging
Sponsor: GE Healthcare

 
 
Page 1 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare - Confidential 
Clinical Study Protocol: 
Clinical Evaluation Of MP26 Features in Adults  
(Study No. 114.03-2016-GES-0001) 
 
Version: 4.0; 30/Aug/2016 
 
 
Sponsor: 
 
General Electric Company, acting through its GE Healthcare Business 
3000 N. Grandview Blvd 
Waukesha, WI 53005 
Sponsor Contact:  
Kevin Siewert, Clinical Affairs Project Manager 
Tel:  
 
1-262-409-5722 
E-mail:   
Kevin.R.Siewert@ge.com 
Medical Monitor:  
Tibor Duliskovich, MD, Medical Director 
Tel:  
 
+1-262-391-6852 
E-mail:   
Tibor.Duliskovich@ge.com 
SAE Contact:  
SAE@ge.com 
Investigational Device/Product: ZTE MRAC and Q Static (Q. 
MRAC) on the GE SIGNA PET/MR MP software platform 
Modality: MRI 
FOR QUALIFIED INVESTIGATORS, STUDY STAFF, AND THEIR 
ETHICS COMMITTEE(S) ONLY 
 
CONFIDENTIALITY STATEMENT 
Information in this RESEARCH STUDY PROTOCOL is for investigators, site personnel involved with the study, ethics 
committee(s), and/or their authorized representative(s) except as required to obtain consent from study 
participants or as otherwise required by law. Once signed, the terms of the protocol are binding for all parties. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 2 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
The Sponsor and Investigator have approved this protocol version, and I confirm hereby to conduct the study 
according to the protocol and in accordance with applicable principles of the World Medical Association 
Declaration of Helsinki and Good Clinical Practice (GCP) guidelines as per ISO 14155:2011, any conditions of 
approval imposed by the reviewing EC or governing regulatory body, and applicable laws and regulations. The 
investigator should not deviate from this protocol except for emergency use. I have read and understood and 
agree to abide by all the conditions and instructions contained in this protocol. 
 
Local Principal Investigator at study site: 
 
Investigator Signature 
 
Date 
 
 
 
Print Name 
 
 
 
 
 
Site Name, Department, Address 
 
 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 3 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
Table of Contents 
Document and Version Control........................................................................................................... 5 
List of Abbreviations and Terms ......................................................................................................... 6 
Study Synopsis ................................................................................................................................... 7 
Administrative Structure of Investigation ........................................................................................... 9 
1. Background and Justification ...................................................................................................... 10 
2. Device/Product Description ........................................................................................................ 11 
 
Identity, Mechanism, and Function ........................................................................................................... 11 
 
Intended Use.............................................................................................................................................. 11 
 
Concomitant/Ancillary Administrations .................................................................................................... 11 
 
Accountability ............................................................................................................................................ 12 
 
Anticipated Risks and Benefits ................................................................................................................... 12 
3. Study Objectives and Endpoints ................................................................................................. 14 
 
Purpose of the Study ................................................................................................................................. 14 
 
Study Endpoints ......................................................................................................................................... 14 
 
Summary of Study Design .......................................................................................................................... 14 
4. Study Design .............................................................................................................................. 15 
 
Study Population........................................................................................................................................ 15 
 
Number of Subjects ................................................................................................................................... 15 
 
Protection of Vulnerable Subjects ............................................................................................................. 15 
 
Eligibility Criteria ........................................................................................................................................ 16 
 
Recruiting and Screening ........................................................................................................................... 17 
 
Criteria for Withdrawal/Discontinuation ................................................................................................... 17 
5. Study Procedures ....................................................................................................................... 18 
 
Activities Prior to Research PET/MR Exam ................................................................................................ 18 
 
Activities during Research PET/MR Scanning and Data Acquisition .......................................................... 19 
 
Activities after PET/MR Scanning .............................................................................................................. 20 
 
Follow-up Visits .......................................................................................................................................... 21 
6. Study Data Collection and Assessments ...................................................................................... 21 
 
Primary Assessment ................................................................................................................................... 21 
 
Secondary Assessments ............................................................................................................................. 21 
 
Safety Assessments .................................................................................................................................... 22 
7. Qualification and Training Plan ................................................................................................... 23 
 
Staff Qualifications ..................................................................................................................................... 23 
 
Training Plan for the Protocol and Research Device/Product ................................................................... 23 
8. Safety ........................................................................................................................................ 23 
 
Anticipated Adverse Events ....................................................................................................................... 23 
 
Adverse Event Definitions .......................................................................................................................... 25 
 
Documentation of Safety Events ............................................................................................................... 25 
 
Reporting of Safety Events and Device Deficiencies/Complaints .............................................................. 26 
 
Device Deficiencies/Complaints ................................................................................................................ 26 
9. Ethical Conduct of the Study....................................................................................................... 27 
 
Ethics Committee ....................................................................................................................................... 27 
 
Regulatory Agencies and Competent Authority(ies) ................................................................................. 27 
 
Management of Protocol Modifications and Amendments ...................................................................... 27 
 
Participant Information and Informed Consent ........................................................................................ 28 
 
Early Termination of the Study .................................................................................................................. 28 
10. Statistical Methods .................................................................................................................... 28 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 4 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
 
Statistical Hypothesis ................................................................................................................................. 28 
 
Sample Size Determination ........................................................................................................................ 28 
 
Statistical Analysis ...................................................................................................................................... 29 
 
Handling of Missing Data ........................................................................................................................... 29 
 
Deviation(s) from the Original Statistical Plan ........................................................................................... 29 
11. Quality Assurance and Control ................................................................................................... 29 
 
Data Management ..................................................................................................................................... 29 
12. Monitoring Plan ......................................................................................................................... 31 
 
Confidentiality and Data Protection .......................................................................................................... 31 
 
Publication Policy ....................................................................................................................................... 31 
References ....................................................................................................................................... 32 
Appendix A - Study Site and Investigator List .................................................................................... 33 
Appendix B - Amendment to Protocol Version 1.0 to 2.0 ................................................................... 34 
Appendix C - Amendment to Protocol Version 2.0 to 3.0 ................................................................... 39 
Appendix D - Amendment to Protocol Version 3.0 to 4.0 ................................................................... 42 
 
List of Figures and Tables 
Table 1. Target quota blocks for subject enrollment/target datasets ......................................................................... 15 
Figure 1. Study procedure for research PET/MR scans relative to clinically indicated imaging (PET/CT or PET/MR) 
with injected radiotracer ............................................................................................................................................. 19 
Table 2. Characteristics recorded to the CRF during PET/MR scan sessions ............................................................... 20 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 5 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
DOCUMENT AND VERSION CONTROL 
This section records all changes made to the protocol for a specific study. In the table below, record every relevant 
change by indicating what changes were made. 
Revision 
Date 
Revision Author 
Comments/Changes 
1.0 
17/Jun/2016 
Angela Johnson 
Clinical writer – initial draft. 
2.0 
09/Aug/2016 
Angela Johnson 
Clinical writer – To expand the study population to be 
inclusive of eligible patients with an indication for 
PET/CT or PET/MR as detailed in APPENDIX B - 
AMENDMENT TO PROTOCOL VERSION 1.0 TO 2.0. 
3.0 
30/Aug/2016 
Angela Johnson 
Clinical writer – To clarify that subjects will only receive 
one type of research exam (ZTE or Q.Static) not both, as 
detailed in APPENDIX C - AMENDMENT TO PROTOCOL 
VERSION 2.0 TO 3.0. 
4.0 
30/Aug/2016 
Angela Johnson 
Clinical writer – Remove legacy element in Table 2 that 
inadvertently was included in this version when 
amendment 3.0 was approved in the Sponsor’s MWS 
documentation system. 
 
 
 
 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 6 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
LIST OF ABBREVIATIONS AND TERMS 
3.0T HNU 
 
3.0T Head and neck unit  
3.0T LAA 
 
3.0T Lower anterior array 
3.0T PET/MR CMA 
3.0T PET/MR Central Multiplexed Array  
3.0T UAA 
 
3.0T Upper anterior array 
8-ChBr  
 
PETMR 8 Channel High Resolution Brain Array 
ADE 
 
 
Adverse Device Effect 
AE 
 
 
Adverse Event 
ALARP  
 
As Low as Reasonably Possible 
AMA 
 
 
American Medical Association  
CA 
 
 
Competent Authority 
CAPM 
 
 
GE Clinical Affairs Project Manager 
CCG 
 
 
Case Report Form Completion Guidelines 
CFR 
 
 
Code of Federal Regulations 
CHF 
 
 
Clinical History File (synonymous with e-Trial Master File) 
CRF 
 
 
Case Report Form 
DCF 
 
 
Data Clarification Form 
EC 
 
 
Ethics Committee 
EU 
 
 
European Union 
FDA 
 
 
United States Food and Drug Administration 
GCP 
 
 
Good Clinical Practice (see ISO 14155:2011) 1 
GE 
 
 
General Electric 
GEHC 
 
 
General Electric Healthcare 
GEMflex coil 
 
GEM (Geometry Embracing Method) Flex Coil Array  
ICF 
 
 
Informed Consent Form 
ISO 
 
 
International Standards Organization 
MP 
 
 
GE MR Program Identifier 
MRAC 
 
 
MR-based attenuation correction 
MRDD  
 
Magnetic resonance diagnostic devices  
MRI 
 
 
Magnetic resonance imaging 
MWS 
 
 
GE MyWorkshop Internal Documentation System 
PET 
 
 
Positron Emission Tomography 
PET/MR  
 
GE SIGNA hybrid PET and MRI system 
PNS 
 
 
Peripheral nerve stimulation 
RF 
 
 
Radiofrequency 
SADE 
 
 
Serious Adverse Device Effect 
SAE 
 
 
Serious Adverse Event 
SAR 
 
 
Specific Absorption Rate 
SNR 
 
 
Signal to noise ratio 
 
SPR 
 
 
System Problem Report 
T 
 
 
Tesla 
US 
 
 
United States 
ZTE 
 
 
Zero echo time 
 
 
 
 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 7 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
STUDY SYNOPSIS 
Sponsor: 
General Electric Company, acting through its GE Healthcare Business 
Research Type: 
This is an open label, non-randomized, prospective Clinical research study conducted in a 
sample population considered representative of the intended clinical population. 
Regulatory Status: 
This is a pre-market research study of the following devices/products:  
Pre-market devices:  Zero echo time (ZTE) sequence for head attenuation correction and Q 
Static (Q. MRAC) for SIGNA PET/MR MP software platform  
Background and 
Rationale: 
The purpose of the study is to collect representative clinical images of demonstrated 
diagnostic quality using the ZTE MRAC and Q Static (Q. MRAC) on the GE SIGNA PET/MR 
MP software platform. The images and summary data from this study are intended for use 
in regulatory submission. 
Procedures/ 
Methods: 
Adult subjects with pre-existing clinical indications for PET/CT or PET/MR with radiotracer 
injection will be enrolled to undergo a PET/MR exam lasting up to 1 hour (which includes 
screening and approximately 30 minutes of scanning) within the tracer validity time frame 
in addition to their clinically indicated exam. During each scan, the operator will complete 
with the ZTE MRAC or Q Static (Q. MRAC) research protocol(s) appropriate for the 
subject’s indication. As part of the study, the corresponding PET/CT images will also be 
collected for ZTE subjects. Images collected from the sites will be post-processed outside 
of the clinical care environment by the Sponsor or its delegate using investigational MR 
post-processing software, and resultant images will be read by the site for diagnostic 
acceptability and by independent readers for scaled diagnostic image quality, as described 
in the Blinded Reader Evaluation (BIE) plan. The cumulative results of this study and 
concurrent studies of the device conducted by the Sponsor may be used to support 
regulatory submission of the devices under study. 
Objectives: 
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. 
Endpoints: 
 
Primary Endpoints:  
• 
Independent radiologist/nuclear medicine physician determination of diagnostic 
image quality considering all evaluable images from each subject (scored on a 5-
pt Likert scale) 
Secondary Endpoints: 
• 
Site level determination of diagnostic acceptability (Y/N) based on consensus 
between radiologist(s) and nuclear medicine physician(s) at the site 
• 
Ease of use per procedure rated on a 5-pt Likert scale score 
• 
Functionality rated for each feature per procedure on a binary (Y/N) 
performance scale 
Safety Endpoints: Type and number of safety events (AEs and SAEs) and device issues 
(malfunctions, user errors, and labeling issues) will be summarized. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 8 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
Summary of Analysis: 
The Statistical Analysis Plan (SAP) prepared by the Sponsor’s biostatistician prior to the 
start of independent reading will detail the study analyses.  
Eligibility criteria: 
 
Inclusion criteria: 
Subjects who meet all of the following 
inclusion criteria may be included that: 
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: 
Subjects who meet any of the following 
exclusion criteria will be excluded that: 
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.  
 
Sample size and Sites: 
Up to 75 adult subjects will be enrolled at one site.  
Study duration: 
The study is expected to last about 2 months. 
Estimated start date: 01/Oct/2016 
Estimated end date: 01/Dec/2016 
 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 9 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
ADMINISTRATIVE STRUCTURE OF INVESTIGATION 
Clinical Affairs Project 
Manager 
(Sponsor Contact):  
Kevin Siewert, Clinical Affairs Project 
Manager III 
Tel:  
+1-262-409-5722 
e-mail:  Kevin.R.Siewert@ge.com 
GE Healthcare (GEHC), Clinical Affairs  
Address:  3000 N. Grandview Blvd. 
Waukesha, WI, 53188 
Research Manager:  
Yi Xia, PhD. Senior Research 
Manager – PET/MR 
Tel:  
+1-262-312-1095 
e-mail:  Yi.Xia@ge.com 
GEHC, MR Business 
Address:  3200 N. Grandview Blvd. 
Waukesha, WI, 53188 
Medical Monitor:  
 
Tibor Duliskovich, MD, Medical 
Director 
Tel:  
+1-262-391-6852 
e-mail:  Tibor.Duliskovich@ge.com 
GE Healthcare (GEHC), Medical Affairs  
Address:  3000 N. Grandview Blvd. 
Waukesha, WI, 53188 
Biostatistician: 
 
Keyi Wang, PhD, Biostatistician 
Tel:  
+1-262-548-2945 
e-mail:  Keyi.Wang@ge.com 
GE Healthcare (GEHC), Clinical Affairs Operations  
Address:  3000 N. Grandview Blvd. 
Waukesha, WI, 53188 
Clinical Writer: 
 
Angela N. Johnson, MSE, RAC 
Tel:  
+1-262-226-9495 
e-mail: Angela.Johnson@ge.com 
GE Healthcare (GEHC), Clinical Affairs Operations  
Address:  3000 N. Grandview Blvd. 
Waukesha, WI, 53188 
 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 10 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
1. BACKGROUND AND JUSTIFICATION 
Hybrid (or combined) PET/MR systems have become available for clinical use in many regions of the 
world, including Europe, China, and the United States. PET/MR systems combine the capabilities of data 
acquisition for PET and MR in one device, so that more information can be taken during a single scan 
session. The excellent functional and morphological MRI capabilities are complemented by the high 
signal-to-noise ratio PET images. The advantage of this approach is in the possibility of combining the 
entire range of functional and morphological capabilities of MRI with tracers labeled with radioisotopes 
that are already commercially distributed, such as 18F-based radiotracers, and other short half-life 
radioisotopes (e.g. 11C-Choline 2 or 15O-water 3). This may allow physicians to better highlight specific 
pathological and physiological mechanisms during clinical exams. PET and MRI are useful for combined 
diagnostic use to enhance images and indicate cancerous and inflammatory abnormalities in tissues, and 
contrast-enhanced MR offers potential benefits over routine MR without contrast in identifying 
revascularization and metastatic movement of cancer. 4, 5, 6  
The planned new release of GE SIGNA PET/MR MP26 software platform introduces several improved 
features, including Zero echo time (ZTE) scan for head attenuation and Q.Static. Techniques using ZTE 
MR have been explored for bone visualization and have been shown to be an efficient means of 
obtaining high-resolution maps of bone tissue with sufficient anatomic accuracy. 7, 8 Images acquired 
with the ZTE sequence can be segmented to extract bone structure, and this permits anatomically 
accurate bone to be added to the head attenuation map for attenuation correction of the PET data in 
PET/MR. 7 Such attenuation correction may be used as an alternative technique to the currently used 
‘Atlas’ method. In addition, the platform will also introduce a Q.MRAC feature, which provides the 
ability to correct for respiratory motion during the MRAC portion of a PET/MR exam. It has the goal to 
create a quiescent (end expiratory) phase PET image with a phase-matched MR based attenuation 
correction, which is intended to provide more accurate attenuation correction for GE Q.Static PET 
images. 
This study is being conducted to demonstrate diagnostic image quality using the ZTE and Q.Static MRAC 
features in a representative sample of clinical cases requiring head and/or whole-body PET/MR scans.  
  
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 11 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
2. DEVICE/PRODUCT DESCRIPTION 
 
Identity, Mechanism, and Function 
Name:  
ZTE MRAC and Q Static (Q. MRAC) on the GE SIGNA PET/MR MP software platform 
Modality/Type: 
MRI 
Manufacturer:  
GE Healthcare 
Software version: 
Correspondent enabling SIGNA software platform 
Regulatory Status:  
Pre-market 
The research device(s), instructions for use, or packaging shall indicate that the research device/product 
is for use in a research investigation, in accordance with US FDA 21 CFR and other applicable laws and 
regulations. The investigational device will be exclusively used for research purposes. 
The results of this study are intended for use in 510(k) submission to the United States Food and Drug 
Administration (FDA). Results may be used to help commercialize the product in other global regions in 
the future, at the discretion of the Sponsor. 
 Zero echo time (ZTE) Software Feature 
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. ZTE 
functions serves a similar clinical purpose as existent visualization techniques (for example Atlas scans).  
 Q Static (Q. MRAC) Software Feature 
In addition, the platform will introduce 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. The planned new release of GE SIGNA PET/MR MP26 software platform 
introduces an improved Q.Static feature with Q.MRAC, which provides the ability to correct for 
respiratory motion during the MRAC portion of a PET/MR exam. It has the goal to create a quiescent 
(end expiratory) phase PET image with a phase-matched MR based attenuation correction, which is 
intended to provide more accurate attenuation correction for GE Q.Static PET images. 
 
Intended Use 
ZTE MRAC and Q Static (Q. MRAC) on the GE SIGNA PET/MR MP software platform are MR features 
intended to be used by trained physicians to aid in diagnosis. The procedures conducted in this study are 
intended for research purposes and are not intended as a substitute for required medical care. 
 
Concomitant/Ancillary Administrations 
 Medications and Biologic Products 
No medications or biologic products will be administered as part of the study procedures. Prior to 
participation in the study, subjects with clinical indications for PET/CT or PET/MR exams will receive 
their clinically indicated injected radiotracer and any other medically necessary medications as ordered 
by their regular physician. Due to the in vivo half-life of radiotracer agents, it is reasonably expected that 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 12 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
subjects participating in the study will have active radiotracer in their bodies during their additional 
research PET/MR scan; therefore no additional radiotracers will be administered as part of the study. No 
sedatives or contrast agents will be administered for research purposes. 
 Dosimetry 
It is important to note that the patient will not receive a second radiotracer injection for the research 
PET/MR study. The residual radioactivity from the initial radiotracer injection of the clinical PET exam 
will be adequate.  
 Laboratory Tests 
No laboratory tests are planned as part of the study procedures. 
 
Accountability 
Accurate and adequate records will be maintained for all devices, from time of shipment to the sites 
until return or disposal of all devices issued by the Sponsor as part of this study, as required by 
applicable laws and regulations. The Principal Investigator will be ultimately responsible for the security 
and integrity of research devices/products at the investigational site during the course of the study. The 
unique identifying information of post-processing devices used as part of this study will be recorded by 
the Sponsor. 
 Issuance 
The investigational PET/MR software will be provided by Sponsor and installed on existing hardware 
platforms installed at the investigational site. Some parts of the study require post-processing of 
clinically acquired MR data conducted outside of the clinical care environment. Study post-processing 
will be conducted under the control of the Sponsor and may utilize investigational software and 
workstations required for post-processing tasks (such as AW Workstations or equivalent). No human 
subjects will be directly exposed to post-processing devices as part of this study. The Sponsor will 
provide necessary installation support, calibration, and maintenance to the device and its software 
components as necessary to ensure safety and maintain integrity of study data.  
 Disposition 
The investigational components provided by the Sponsor will be uninstalled after the study by this 
Sponsor, in accordance with applicable laws and regulations. Identifiable subject information will be 
removed from devices, including post-processing software and workstations, used by or returned to the 
Sponsor at the end of the study. 
 
Anticipated Risks and Benefits 
The devices under study have undergone risk assessment, in accordance with International Standards 
Organization (ISO) 14971:2010, and risks have been mitigated to levels as low as reasonably possible 
(ALARP). Risks associated with the PET/MR procedures in this study are similar to the risks found in 
typical clinical MR (field strengths less than 3.0T) or PET scans using devices that are already approved 
for regular commercial use. Hybrid (combined) PET/MR systems have been commercially available in the 
Europe and the US since 2011, and the GE PET/MR SIGNA system has been commercially marketed in 
2015 in the US and EU. 7, 8 During a typical PET/MR exam, patients will be exposed to minimal levels of 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 13 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
ionizing radiation from their clinically indicated PET radiotracer administration and the magnetic and 
electromagnetic fields of the device, at levels within the ranges set forth by established safety 
standards. 9  
The study does not require any clinical follow-up. There are no expected risks to subjects, operators, or 
others in this study beyond those of comparable clinical diagnostic imaging procedures routinely used in 
clinical practice. Subjects are not expected to benefit directly from study participation. The results may 
benefit future patients by helping to better understand new technology to support PET/MR technology 
development and commercialization. 
 Risk Category and Rationale 
The ZTE MRAC and Q Static (Q. MRAC) on the GE SIGNA PET/MR MP software platform and associated 
MR hardware and software systems required for this research, as used in this study, are not considered 
a significant risk device per the 21 CFR §812.3 definition:  
1) it is not intended as an implant;  
2) is not purported or represented to be for a use in supporting or sustaining human life;  
3) is not for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health; and 
4) it does not otherwise present a potential for serious risk to the health, safety, or welfare of a 
subject. 
In the United States (US), the SIGNA PET/MR Scanners (GE Medical Systems, LLC, Waukesha, WI) is 
considered Class II magnetic resonance diagnostic devices per 21 CFR §892.1000. In the US, MR software 
features under study are considered pre-market MR software components under 21 CFR §892.1000 and 
Class II Picture archiving and communications system per 21 CFR §892.2050. Workstations for 
processing MR images (such as the VolumeShare Advantage 5 or “AW”) are considered to be a Class II 
Picture archiving and communications system per 21 CFR §892.2050. 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 14 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
3. STUDY OBJECTIVES AND ENDPOINTS 
 
Purpose of the Study 
The purpose of the study is to collect representative clinical images with demonstrated diagnostic image 
quality using ZTE MRAC and Q Static (Q. MRAC) software features. The images and summary data from 
this study are intended for use in regulatory submission(s). 
 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 Endpoints 
 Primary Endpoints: 
Independent radiologist/nuclear medicine physician determination of diagnostic image quality 
considering all evaluable images from each subject (scored on a 5-pt Likert scale) 
 Secondary Endpoints:  
Site level determination of diagnostic acceptability (Y/N) based on consensus between radiologist(s) and 
nuclear medicine physician(s) at the site 
Ease of use per procedure rated on a 5-pt Likert scale score 
Functionality rated for each feature per procedure on a binary (Y/N) performance scale 
 Safety Endpoints 
Type and number of safety events (AEs and SAEs) and device issues (malfunctions, user errors, and 
labeling issues) will be summarized. 
 
Summary of Study Design 
This is a pre-market, open label, prospective, non-randomized clinical research study at one site. The 
study is designed to allow for sample PET/MR image collection and to demonstrate diagnostic image 
quality of resultant sample image sets from each participating subject. The results of this study will be 
analyzed according to a prospective Blinded Image Evaluation (BIE) plan and Statistical Analysis Plan 
(SAP) prepared by the Sponsor prior to the start of image reads. This study is run concurrently with 
other studies of the device conducted by the Sponsor and it is prospectively expected that the 
cumulative results of these studies may be used to support regulatory submissions. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 15 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
4. STUDY DESIGN 
 
Study Population 
Subjects will be enrolled that have a clinical indication for PET/CT or PET/MR with radiotracer injection 
prescribed for their medical care outside of the study. Sites should make reasonable attempts to ensure 
diversity of clinical state (including injury severity or extent of disease progression) within the enrolled 
population in order to achieve a sample maximally representative of the intended use population. 
 
Number of Subjects 
The study aims to acquire up to 75 clinical PET/MR image sets (up to 38 subjects will be enrolled to have 
a ZTE MRAC exam and the remaining 37 subjects will be enrolled to have a Q Static (Q. MRAC) exam. In 
the event that a subject scan does not produce images, as in the case of withdrawal or technical issues 
preventing scanning, additional subjects may be enrolled until the target number is achieved (not to 
exceed a maximum of 75 subjects during the course of the study) as described in Section 10.2 - Sample 
Size Determination. The minimum number of necessary subjects will be enrolled to achieve the target 
number of datasets. 
 Enrollment Quota 
Subjects will be enrolled based on a quota block method based on scan type (relative to the patient 
clinical indication for PET/CT or PET/MR). Each subject may have only one type of scan towards these 
quota blocks (ZTE or Q.Static MRAC), not both (Table 1). 
Table 1. Target quota blocks for subject enrollment/target datasets 
Scan Type 
Target number of subject datasets 
(NTarget = 30) 
ZTE MRAC 
At least 30 subject scans 
(Nneuro = 30 to 38) 
Q Static (Q. MRAC) 
At least 30 subject scans 
(Nbody = 30 to 37) 
 
Protection of Vulnerable Subjects 
Vulnerable subjects are individuals whose willingness to volunteer in a clinical investigation could be 
unduly influenced by the expectation, whether justified or not, of benefits associated with participation 
or of retaliatory response from senior members of a hierarchy in case of refusal to participate. The 
Sponsor shall avoid improper influence on, or inducement of, the subject, monitor, any investigator(s), 
or other parties participating in, or contributing to, the clinical investigation. 
All investigators shall avoid improper influence on, or inducement of, the subject, Sponsor, monitor, 
other investigator(s), or other parties participating in, or contributing to, the clinical investigation. 
This study does not examine any groups of subjects who are considered to be vulnerable subjects in the 
country in which the study is being conducted. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 16 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
 
Eligibility Criteria 
 Inclusion Criteria  
Subjects should be recruited to cover a variety of clinical indications which represent clinical cases seen 
in PET examinations. Subject must meet all of the following inclusion criteria to be included: 
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  
Subjects who meet any of the following exclusion criteria will be excluded that: 
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); 1 
4. Have implants or attached medical devices that could be unsafe for MRI; 2 
5. Have medical conditions or require urgent care that could make it unsafe to participate 
 
 
                                                          
1 The maximum patient size for the bore is an axial diameter of 55 cm (~21.7 in.) or weight of 227 kgs (~500.5 lbs). 
2 Potentially unsafe devices include metallic/conductive or electrically/magnetically active implants or attached medical devices 
(except dental devices/fillings, surgical clips, and surgical staples), as determined by the site institutional MRI safety policies. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 17 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
 
Recruiting and Screening  
Subjects will be recruited for potential enrollment in this study prior to their clinically indicated PET/CT 
or PET/MR exam according to the institutional procedures of the investigational site and its governing 
IRB. Participants identified after completing their clinically indicated imaging exam may be recruited, if 
otherwise eligible and within the study time window. All participation will be voluntary, and written 
informed consent will be collected from each participant prior to exposure to any investigational devices 
or procedures. 
Subjects will be screened for enrollment in this study against the inclusion and exclusion criteria 
according to the standard procedures of the investigational site. 
Following recruitment, a subject will be considered enrolled (the point of enrollment) once he/she signs 
and dates the informed consent form (ICF). Safety events and device issues will, however, only be 
reported during the period of exposure to the investigational PET/MR device (from the time the subject 
enters until the time the subject leaves the PET/MR suite), and not for clinically indicated imaging (e.g. 
PET/MR or PET/CT) procedures that may be observed after the patient provides consent but are not a 
consequence of study participation.  
Once enrolled, the subject will be assigned a unique subject number, which will not contain information 
that could identify the subject. The unique subject number will be used to label case report form (CRF) 
data for the subject throughout his/her participation in the study. 
 
Criteria for Withdrawal/Discontinuation 
A subject may withdraw from study participation at any time, for any reason. The investigator may 
withdraw a subject at any time, for any reason. The reasons for withdrawal and discontinuation for any 
subject shall be recorded. These will be reported to the Sponsor. The EC should be notified per their 
notification of subject withdrawal policy. 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 18 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
5. STUDY PROCEDURES  
 
Activities Prior to Research PET/MR Exam 
For all subjects, study staff will confirm that the subject is eligible and complies with applicable site 
requirements prior to starting study procedures. After the subject completes the ICF, he/she will be 
required to complete certain activities to participate in the study.  
 Pre-Screening Activities (All Subjects) 
• 
Verify site institutional policy(ies) for MR safety are followed. 
• 
Record implant information for subjects with implants allowable per the inclusion/exclusion 
that will be present during scanning (with the exception of passive dental filling/implants, 
surgical clips, or surgical staples)*, as follows: 
i. 
Name of the device 
ii. 
Manufacturer of the device 
iii. 
Model Number of the device 
Note: If any or all information is not available, write N/A in the applicable area(s) 
• 
Record subject characteristics, as follows: 
i. 
age (in years) 
ii. 
gender 
iii. 
weight 
iv. 
height 
 
Pre-Screen Activities for PET/CT Subjects 
• 
Record clinically indicated PET/CT information (before the PET/CT scan when possible to limit 
delay time between PET/CT and research PET/MR exam), including start and end time of the 
PET/CT scan and information about injected radiotracer, as follows: 
i. 
radiotracer type, dose and units, and time of injection  
ii. 
clinical indication for PET/CT scanning (oncology, neurology, and/or cardiac etc.) 
iii. 
date and time of PET/CT 
• 
Check for completeness of acquired PET/CT images, if a subject is missing required PET/CT 
images, the subject may be withdrawn from the study. PET/CT images will be collected as part of 
the study. 
• 
Check for solid food or insulin administration. If a study subject is administered insulin, solid 
food, or any non-water beverage prior to the PET/MR imaging that can be expected to interfere 
with radiotracer activity, the subject may be withdrawn from the study at the discretion of the 
investigator if such administration(s) could interference with performing study procedures 
and/or radiotracer bioavailability during the study period. 
 
Activities Required before Study PET/MR for All Subjects 
• 
Encourage subjects to empty their bladder prior to PET/MR scanning. 
• 
Provide MR-safe clothing according to participating investigational site’s standard procedures, 
such as hospitals gowns, and isolate all non-MR compatible equipment or devices and route the 
devices and/or cables as required out of the magnet room. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 19 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
• 
Provide mandatory hearing protection, as per site institutional procedure. 
 
Activities during Research PET/MR Scanning and Data Acquisition 
 Subject Procedure 
The site should perform research PET/MR scans during the time that the radiotracer validity time frame. 
Typically research PET/MR exams should be started with approximately 4 hours of radiotracer 
administration; however, the site may scan a subject at their discretion is the scan is expected to take 
place during the clinical validity window based on the investigator’s expertise (not required to be within 
4 hours, Fig. 1). This is to ensure sufficient radiotracer activity during the investigational procedure. 
Figure 1. Study procedure for research PET/MR scans relative to clinically indicated imaging (PET/CT or PET/MR) with 
injected radiotracer 
 
*MR Safety Screening and Pre-screening activities identified in Section 5.1 Activities Prior to PET/MR (Pre-Screen) 
should be completed prior to the start of the study PET/MR scan. 
The research PET/MR scan session will be performed while the subject is lying on a scan table. During 
this time, the subject may be asked to shift position to one side or another, lie still and to follow simple 
instructions such as to hold his/her breath at specified times.  Subjects may be provided with a calling 
system that allows him or her to contact the Device Operator at any time during the scan. While the 
subject is in the scanner, the device operator will remain where the subject is visible (e.g. through a 
window) and audible (e.g. through an intercom).  
The PET/MR exam may last up to a 1 hour (which includes screening and approximately 30 minutes of 
scanning). Start and end time of research PET/MR scanning and additional information will be recorded 
as per Table 2.  
 ZTE MRAC and Q Static (Q. MRAC) PET/MR Scanning Procedure 
The device operator will acquire scan data using default PET/MR scan protocols, default MR-only scan 
protocols, and other scanning protocols optimized by the operator as appropriate for the subject’s 
clinical state. The scan protocols and associated pulse sequences used shall be chosen by the 
investigator. For PET/MR simultaneous scanning, the first scan will be a whole body localizer. The user 
will then define n beds (n ≤ 14). The user will have the option to insert as many MR scans at each bed 
position, although a MR attenuation correction scan will always be acquired first at each bed position 
(approximately a 30 second scan). The PET will continue to acquire data until the time set by the 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 20 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
operator has elapsed. The system will then automatically move to the next bed position. The user will be 
able to view the PET images overlaid on the MR images from each bed after it has been reconstructed. 
During each scan, the operator should complete ZTE MRAC or Q Static (Q. MRAC) protocol appropriate 
for the subject’s indication, and record the sequence used in the exam. For Q Static (Q. MRAC) scans, the 
site should conduct 5 non-gated MRAC acquisitions and 5 gated acquisitions for each subject around the 
lung/abdominal region including the diaphragm. For all scans, the device operator should attempt to 
complete both PET and MRI scans on the PET/MR system and to collect an image set that includes both 
PET and MRI images. At the end of each scan session, the device operator will record information about 
the device used, the time of the scan session and his/her observations in the Case Report Forms (CRFs). 
If the device operator is unable to collect both PET and MRI images, he or she should record the reason 
on the Case Report Form (CRF). The device operator will save the images and raw data. 
Table 2. Characteristics recorded to the CRF during PET/MR scan sessions 
Coil(s) Used 
Gating device(s) used 
Medical tubes wires/cables 
 
• 
3.0T PET/MR CMA   
• 
3.0T HNU 
• 
3.0T UAA  
• 
3.0T LAA 
• 
GEM Flex Coil 16-S, 
M, L Array 
• 
3.0T Split head coil 
• 
PETMR 8Ch HiRes 
Brain Array  
• 
3.0T HD Flat GEM 
Table Breast Array 
• 
Other, specify 
 
• 
Respiratory bellows 
• 
ECG leads 
• 
Peripheral gating 
photopulse sensor 
 
• 
None 
• 
IV 
• 
Catheterization 
• 
Breathing tube 
• 
Oxygen 
• 
ECG Monitor 
• 
Other, specify 
 
 Emergency Procedures 
In the event of a medical emergency, the scan will be stopped immediately and facility’s emergency 
response plan will be followed. The subject will be provided with emergency care as needed. 
The subject’s care shall take precedence over any imaging associated with the study. In the event the 
subject experiences discomfort or wishes to stop the exam for any reason, the exam will be immediately 
stopped and appropriate follow up response will occur. The event will be recorded in compliance with 
US FDA and GE Healthcare safety reporting requirements.  
 Incidental Findings 
The additional PET/MR procedures performed in this study are for research only and are not intended 
for diagnostic use. Should the device operator observe what they interpret to be a potential 
abnormality, the investigator will evaluate the findings and alert the patient if necessary. The 
investigator may recommend diagnostic exams to be performed independent of the study. No medical 
or diagnostic care of any kind will be rendered based on study image sets using the research PET/MR. 
 
Activities after PET/MR Scanning 
Upon completion of the exam, the device operator or those assisting him/her will assist the subject from 
the device and out of the scan area. Any reported safety or device issues will be recorded to the CRF up 
until the time the subject leaves the PET/MR suite.  

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 21 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
After the exam is complete and the subject has left the PET/MR suite, the device operator will complete 
the CRF and store the image sets for the scan, which will be labeled with the subject’s unique ID 
number. All images collected from clinical sites will be sent to the Sponsor or its delegate for 
investigational post-processing with the investigational technology prior to image reads.  
 
Follow-up Visits 
All patient procedures will be conducted during a single visit. No follow-up visits are required. 
6. STUDY DATA COLLECTION AND ASSESSMENTS 
 
Primary Assessment 
 Independent Reader Determination of Diagnostic Image Quality 
Diagnostic image quality will be rated on a 5-pt Likert scale by at least 2 independent board certified 
nuclear medicine physician and/or radiologists for all evaluable image sets (including all clinically 
acquired MR image sets able to be successfully post-processed that are complete image sets [not from 
cases of withdrawal or critical deviation that could impair to the quality of data]). Independent reads will 
be conducted outside of the clinical care environment according to the procedures specified in the 
Blinded Image Evaluation (BIE) plan prepared by the Sponsor prior to the start of image reading. 
Identifiable subject information will be removed prior to independent reads. 
Diagnostic image quality will be recorded on a 5-pt Likert scale, where ratings of ≥3 are considered 
acceptable for diagnostic use and ratings of 1-2 are considered unacceptable for diagnostic use, as 
follows: 
1. Unacceptable (cannot be used for diagnostic use) 
2. Poor (not completely suitable for diagnostic use) 
3. Acceptable (suitable for diagnostic use but with minor defects) 
4. Good (good suitability for diagnostic use) 
5. Excellent (excellent suitability for diagnostic use) 
The reader should record the rationale for any image scored unacceptable for diagnostic use (scores of 1 
or 2). And/or provide comments in image annotation or point to the problem area in the images. Scores 
should be based on the entire image set, considering all available views, with the exception of the LAVA 
sequence used for MR-attenuation correction (which should not be considered in the evaluation for 
image quality). 
 
Secondary Assessments 
 Site Determination of Diagnostic Acceptability 
Based on consensus of at least one radiologist and at least one nuclear medicine physician at the site, 
diagnostic acceptability of each evaluable image set (including all clinically acquired MR image sets able 
to be successfully post-processed that are complete image sets [not from cases of withdrawal or critical 
deviation that could impair to the quality of data]). 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 22 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
Binary diagnostic image quality will be recorded by the site on a single CRF that includes the names and 
signatures of both the radiologist and nuclear medicine physician making the evaluation, as follows: 
“Is the image of acceptable quality for diagnostic use? (Y/N)” 
The reader should record the rationale for any “no” answer indicating that the image is not acceptable 
quality for diagnostic use. And/or provide comments in image annotation or point to the problem area 
in the images. Scores should be based on all views included in the image set, considering all available 
views, with the exception of the LAVA sequence used for MR-attenuation correction (which should not 
be considered in the evaluation for image quality).  
 Ease of use 
Each of the following ease of use parameters will be rated by the device operator on a 5-point scale (1 = 
challenging, 2 = somewhat challenging, 3 = neutral neither challenging nor easy, 4 = somewhat easy, 5 = 
easy), where scores of ≥3 are acceptable, as follows: 
• 
Prescribing and Scanning 
o Prescribing PET scan 
o Prescribing MR scans simultaneous with PET 
o Starting and monitoring scanning 
o Reviewing PET and MR image sets 
• 
General Workflow 
o Overall process of doing this exam 
o Performing exam within acceptable duration to meet normal site workflow 
requirements 
 Functionality 
Each of the following parameters for functionality will be rated by the device operator on a binary (Y/N) 
scale, as follows: 
• 
Did the system function to view the PET, MR, and/or fused image sets? 
• 
Did the system function to position subject and coils in scanner? 
• 
Did the system function to prescribe and scan this exam? If no, indicate which (PET, MR, 
and/or fused did not function properly). 
If no is indicated for any functionality, the investigator should indicate the reason in a provided area for 
comments on the Case Report Form (CRF). 
 
Safety Assessments 
The description, severity, and device relatedness of any AE or SAE during the study will be recorded. 
Subjects will, if necessary, be provided with emergency care. In the event of any device issues, the event 
will be recorded. Safety reporting will be conducted as described in this protocol. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 23 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
7. QUALIFICATION AND TRAINING PLAN 
 
Staff Qualifications 
All members of the study staff participating in the conduct of the investigation shall be qualified by 
education, training and/or experience to perform their tasks, and this shall be documented 
appropriately, as per US FDA and ISO 14155:2011.  
 Reader Qualifications 
All readers in this study will: 
• 
Have >4 years of direct experience in evaluating MRI and/or PET image sets. 
• 
Be certified as diagnostic radiology and/or nuclear medicine physicians. 
 
Training Plan for the Protocol and Research Device/Product 
Before starting the study, the study staff will be trained on the clinical investigation requirements set 
forth in this study protocol according to the study Training Plan stored in the Sponsor’s Clinical History 
File (CHF).  
Study staff directly operating or maintaining the investigational PET/MR system will be trained based on 
the training plan and device documentation. Device operators will be qualified to operate the devices, as 
per the policies of the site. 
The Principal Investigator will be ultimately responsible for execution of this study in accordance with 
the protocol and for devices used in this study by members of the study staff. 
8. SAFETY 
 
Anticipated Adverse Events 
MR technologies up to 3.0T have been used in clinical applications for over 30 years and have a well-
documented safety profile. Similarly, PET scanners are widely used in clinical practice. The PET/MR 
scanner does not involve any risks other than those normally associated with routine clinical PET and 
MRI scans, similar to those already performed in many hospitals. The following are some discomfort one 
may experience during a PET/MR scan session. 
Movement of metal objects: PET/MR systems operate in a high field magnetic field typical of MRI 
systems, which can cause movement or projectile motion of certain ferrous metal objects. Though 
injuries are rare (occurring in less than one of 100,000 patients), small objects can cause bruises or cuts, 
and large objects can cause severe trauma or even death. 
Implants: Objects embedded within the body can be affected by the strong external magnetic field near 
and inside of the PET/MR device during an MRI exam, causing movement and/or electronic malfunction 
that can lead to injury or even death.  
Warming and burns: Radiofrequency (RF) energy transmitted by the PET/MR system during MRI 
scanning can result in generalized or localized heating of body tissues, occurring in about 5-10% of 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 24 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
patients. Some subjects may experience sensations of warming and/or perspiration, which can be 
uncomfortable. Though warming can cause burns, severe injuries are rare. 
Peripheral nerve stimulation (PNS): During a PET/MR exam, rapidly changing magnetic fields during MRI 
exams can cause stimulation of nerves, causing unusual generalized or localized “tingling” sensations, 
known as peripheral nerve stimulation (PNS). PNS normally occurs in 5-10% of subjects, but may occur in 
up to 50% of subjects under certain conditions. 
Acoustic Noise: During PET/MR, the MRI system is capable of generating acoustic noise levels higher 
than 99dB. The acoustic noise levels of the system do not exceed 140 dB under worst-case conditions. 
Sometimes, transient hearing loss or “ringing” in the ears (tinnitus) can occur, which it typically is mild 
and resolves spontaneously after scanning. Severe or chronic hearing conditions can occur if proper 
hearing protection is not used, but are rare (occurring in less than one of in 100,000 patients). 
PET Radiotracers and MR contrast agents: Subjects in this study will be administered PET radiotracers 
prescribed as part of their normal medical care, and dosage will not be changed or increased by 
participating in this study. Though no MR contrast agents are being administered solely for the purposes 
of this study, some patients may have incidentally received MR contrast as part of regular medical care 
prior to starting study procedures. The safety and risk profiles of PET radiotracers and MR contrast 
agents are well documented and are not increased by having a PET/MR scanning. These risks vary by the 
type of agent administered, but most commonly include: 
• 
warm or hot (“flushed”) sensations that typically resolve spontaneously; 
• 
transient “metallic” taste that typically resolves spontaneously; 
• 
allergic reactions, ranging from mild irritation, such as itching and hives that may resolve 
spontaneously, to a life-threatening emergency (anaphylactic reaction) that requires additional 
medical care;  
• 
kidney damage as the agent is excreted from the body, a potentially severe condition called 
nephrotoxicity. Risk is increased for subjects with diabetes, chronic renal disease, advanced 
congestive heart failure, concomitant use of non-steroidal anti-inflammatory agents (NSAID).   
• 
unintentional penetration of agents into the local areas surrounding tissues, either by leakage 
(e.g., because of brittle veins in very elderly patients) or direct exposure (e.g. because the 
needle has punctured the vein and the infusion goes directly into the arm tissue), a condition 
known as extravasation. Extravasation typically causes mild effects, such as pain, reddening, or 
irritation at the injection site, but can, in rare cases, cause severe injury requiring medical care. 
• 
for PET radiotracers, a radioactive drug (radiotracer) is injected into the body. This results in a 
small amount of radiation exposure, at very low levels not typically associated with any adverse 
effects on the body. 
• 
for gadolinium-based MR contrast agents, a rare and serious side effect of contrast 
administration is formation of fibrotic nodules and indurations on the skin and other tissues 
throughout the body, called nephrogenic systemic fibrosis (NSF), which is painful and typically 
requires additional medical care. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 25 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
Due to possible effects in the developing fetus and health of the mother, no women that are pregnant 
or suspected to be pregnant will be included in this study. 
There is always a chance of unexpected risks. Throughout the study, the Sponsor will evaluate and 
update safety information in study documents.  
 
Adverse Event Definitions 
Adverse Event (AE): any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device [ISO 14155:2011 3.2]. This includes events related to the 
investigational device or the comparator and to the procedures involved. For users or other persons, 
this is restricted to events related to the investigational medical device. 
Serious Adverse Event (SAE): an adverse event that led to death; led to a serious deterioration in the 
health of the subject, that either resulted in a life-threatening illness or injury, a permanent impairment 
of a body structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical 
intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a 
body function; or led to fetal distress, fetal death or a congenital abnormality or birth defect. Planned 
hospitalization for a pre-existing condition, or a procedure required by the protocol without serious 
deterioration in health, is not considered a SAE [ISO 14155:2011 3.37]. 
Adverse Device Effect (ADE): an adverse event related to the use of an investigational medical device 
[ISO 14155:2011 3.1]. This includes any adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. This includes any event that is a result of a user error or intentional 
misuse of the investigational device [ISO 14155:2011 3.43]. 
Serious Adverse Device Effect (SADE): an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event [ISO 14155:2011 3.36]. 
Device deficiency: an inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety, or performance, such as malfunctions, use errors, and inadequate labelling [ISO 
14155:2011 3.15]. 
Unanticipated serious adverse device effect (USADE): a serious adverse device effect, which by its 
nature, incidence, severity, or outcome has not been identified in the current version of the risk analysis 
report [ISO 14155:2011 3.42]. In the United States, any serious adverse effect on health or safety or any 
life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence in the study documents, 
will be reported in accordance with 21 CFR §812.3 and applicable laws and regulations. 
 
Documentation of Safety Events 
All adverse events (AE), including all serious adverse events (SAE), are required to be collected, 
investigated, and documented during the study reporting period, as defined in the study procedure as 
the time the subject enters until the time the subject leaves the PET/MR suite. Documentation will 
include: 
• 
Description of Event 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 26 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
• 
Date of onset and resolution  
• 
Severity (mild, moderate, or severe)  
▪ 
Mild: Symptom(s) barely noticeable to the subject or does not make the subject 
uncomfortable. The AE does not influence performance or functioning. Prescription 
drugs are not ordinarily needed for relief of symptom(s). 
▪ 
Moderate: Symptom(s) of a sufficient severity to make the subject uncomfortable. 
Performance of daily activities is influenced. Treatment of symptom(s) may be needed. 
▪ 
Severe: Symptom(s) of a sufficient severity to cause the subject severe discomfort. 
Treatment for symptom(s) may be given. 
• 
Serious (yes/no)  
• 
Causal relationship to investigational medical device? (not related, possibly related, or related) 
▪ 
Not related: The adverse event is reasonably expected to be related to (or caused by) a 
concurrent illness, effect of another device/drug or other cause, and is unlikely related 
to the investigational product. 
▪ 
Possibly related: The adverse event is reasonably expected to be related to the 
investigational product, and an alternative etiology is equally or less likely compared to 
the potential relationship to investigational product. 
▪ 
Related: There is a strong relationship to investigational product or recurs on re-
challenge, and another etiology is unlikely or there is no other reasonable medical 
explanation for the event. 
• 
Treatment given and/or action taken (procedure stopped, withdrawn from study, or no action) 
• 
Anticipated (yes/no): Anticipated adverse events for this study are defined in Section 
Anticipated Adverse Events. 
 
Reporting of Safety Events and Device Deficiencies/Complaints 
The following events are to be reported to the Sponsor within 72 hours of the event occurrence and to 
the EC per their policy: 
• 
All SAEs and USADEs 
• 
All device issues that could possible lead to an SAE 
Any study-related death should be reported to the Sponsor with 24 hours. Additional follow-up 
information may be requested by the Sponsor. In addition, safety information may be shared with 
regulatory agencies and other participating sites, as required by applicable law and regulation. 
 
Device Deficiencies/Complaints 
Device deficiencies/complaints should be reported to the study Sponsor contact identified on the cover 
page of this protocol. All device deficiencies/complaints will to be collected, fully investigated, and 
documented in the source document and appropriate case report form (CRF) during the study reporting 
period. The Principal Investigator is responsible for notifying the Sponsor in the event that there is any 
device issue that could potentially lead to a SAE. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 27 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
9. ETHICAL CONDUCT OF THE STUDY 
The study will be carried out in accordance with the protocol and with principles enunciated in the 
current version of the Declaration of Helsinki; the guidelines of Good Clinical Practice (GCP) for medical 
devices, as set forth by ISO 14155:2011 and ISO 14971:2010; applicable sections of US FDA 21 Code of 
Federal Regulations (CFR); and any other applicable state or national legal requirements in the United 
States. 
The study will be conducted and reported in accordance with applicable policies of the requirements of 
the Ethics Committee (EC) and governing regulatory authorities. 
If national or regional EC requirements are less strict than the requirements of GCP, such as ISO 
14155:2011 for medical devices, the Sponsor shall apply the requirements of this International Standard 
to the greatest extent possible, irrespective of any lesser requirements, and shall record such efforts. 
 
Ethics Committee 
The responsible Principal Investigator at each site will ensure that approval from an appropriately 
constituted EC is attained for the clinical study prior to enrolling subjects, and Principal Investigator will 
ensure that documentation of approval is maintained for the duration of the study.  
The Principal Investigator will ensure that the Sponsor is notified of any withdrawal of EC approval 
within 5 working days of such occurrence. If approval is terminated or suspended, the Principal 
Investigator will promptly notify the Sponsor and provide written explanation. 
 
Regulatory Agencies and Competent Authority(ies) 
This study will be conducted in accordance with US FDA requirements. Registration with the agency 
prior to the start of the study is not required for this image evaluation study, in accordance with 
applicable laws and regulations. Any additional requirements imposed by the EC or regulatory authority 
shall be followed. 
 
Management of Protocol Modifications and Amendments  
Substantial amendments will only be implemented after approval of the EC.  
A deviation is any instance(s) of failure to follow, intentionally or unintentionally, the requirements of 
the protocol. Under emergency circumstances, deviations from the protocol to protect the rights, 
safety, and wellbeing of human subjects may proceed without prior approval of the Sponsor and the 
EC/competent authority (CA). Such deviations shall be documented and reported to the Sponsor and the 
EC as soon as possible. Deviations will be reported as: 
• 
Critical Deviations: Deviations that significantly affect the safety, efficacy, integrity, or conduct 
of the study. These deviations must be reported to the Sponsor no later than 5 working days 
from awareness of occurrence and reported to the EC per the deviation reporting policy.  
• 
Non-Critical Deviations: Protocol deviations that do not significantly affect the safety, efficacy, 
integrity, or conduct of the trial. These deviations must be documented on the CRF Protocol 
Deviation page and will be reviewed by the study monitor. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 28 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
Non-substantial modifications may be made during the normal course of device optimization, 
maintenance, and feasibility testing. Non-substantial modifications will be communicated to the CA as 
soon as possible, if applicable, and to the EC per their policy.  
 
Participant Information and Informed Consent  
The investigators will explain to each participant the nature of the study, its purpose, the procedures 
involved, the expected duration of exposure to the investigational device (if applicable), the potential 
risks and benefits, and any potential discomforts. Each participant will be informed that participation in 
the study is voluntary, that he/she may withdraw from the study at any time, and that withdrawal of 
consent will not affect his/her subsequent medical assistance and treatment. The participant must be 
informed that his/her medical records may be examined by authorized individuals other than their 
treating physician. 
All participants for the study will be provided an ICF, describing the study and providing sufficient 
information to allow the participant to make an informed decision about his/her participation in the 
study. Informed consent documents will be subject to approval by the EC prior to enrolling subjects in 
the study. 
The participant should read and consider the statement before signing and dating the ICF, and shall be 
given a copy of the signed document. The ICF must also be signed and dated by the investigator (or 
his/her designee), and it shall be retained as part of the study records.  
 
Early Termination of the Study 
The Sponsor may terminate the study prematurely according to certain circumstances. Examples of such 
circumstances include ethical concerns, insufficient participant recruitment, participant safety concerns, 
alterations in accepted clinical practice that make the continuation of a clinical trial unwise, early 
evidence of benefit or harm of the research product, or for any other reason. 
10. STATISTICAL METHODS 
 Statistical Hypothesis  
No statistical hypothesis is being prospectively tested in this study. As necessary for regulatory 
submission, additional analyses will be detailed prior to the star to independent reads in the Statistical 
Analysis Plan (SAP) prepared by the Sponsor’s biostatistician.  
 Sample Size Determination 
The sample size is based on the Sponsor’s engineering determinations of the required number of sample 
images, and is not prospectively powered to produce statistically powered results. The protocol aims to 
acquire 30 images using Q Static (Q. MRAC) and 30 images using ZTE. Datasets may include one or both 
image type, based on clinical availability, to meet these targets. Assuming than 10% of cases will include 
both types of data and 25% attrition rate due to various causes, this study requires a population (N) such 
as that: 
1.1𝑁−(1.10 × 𝑁)(0.25) = 30 𝑍𝑇𝐸+ 30 𝑄 𝑠𝑡𝑎𝑡𝑖𝑐  

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 29 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
To satisfy this requirement, a minimum population size of N = 72 is required. This is approximated to N = 
75, as this number is considered by the Sponsor to be sufficient to account for unforeseen contributions 
to dropout or evaluable image rates.  
 Statistical Analysis 
 General Statistical Methods 
The study data will be presented in tables, listings, and figures. Data will be summarized using 
descriptive statistics. The descriptive statistics for variables will include mean, standard deviation, 
median, Q1 and Q3, minimum, maximum, and count. Categorical variables will be described with 
counts, percentages. If necessary for regulatory submission, additional statistical methods may be 
employed as detailed in the Statistical Analysis Plan (SAP) prepared by the Sponsor’s responsible 
biostatistician and stored in the study’s clinical history file (CHF). 
 Analysis Set(s) 
The study analysis sets include the Safety Population and Per-protocol population.  
The safety population includes all subjects enrolled and scanned, the per-protocol population include all 
subjects enrolled, scanned, processed with ZTE and/or Q-static and without critical protocol deviation.  
 Analysis of Primary Endpoint(s) 
General descriptive statistical methods will be used to summarize the study diagnostic image quality 
results by reader and overall. 
 Analysis of Secondary Endpoint(s) 
General descriptive statistical methods will be used to summarize each secondary endpoint. 
 Safety Analysis  
Tables and listings of safety events, deviations, and device issues will be prepared, including counts and 
percentages as appropriate. 
10.3 Interim Analysis 
No interim analyses are prospectively planned as part of this study. 
 Handling of Missing Data  
Analysis will be based on collected data, and no imputation will be done for missing data. 
 Deviation(s) from the Original Statistical Plan 
Any changes or deviations from the original statistical plan specified in this protocol will be described 
and justified in the SAP and/or study final report as required by ISO 14155:2011. 
11.  QUALITY ASSURANCE AND CONTROL 
 Data Management 
Data management processes for handling study data will be maintained by the Sponsor. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 30 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
 Completion of Case Report Forms (CRFs) 
The data reported on the CRFs shall be derived from source documents and be consistent with these 
source documents. Paper CRFs and/or electronic CRFs (eCRFs) will be used to collect data. The Sponsor 
will provide CRFs and train study staff on completion of CRFs using Good Documentation Practices 
(GDP). CRF Completion Guidelines (CCG) may be provided by the Sponsor to help facilitate training. 
CRFs are to be completed as information becomes available at the site. CRFs should be signed by 
indicated parties, in indicated area(s), to certify the contents of the form. The Principal Investigator is 
ultimately responsible for ensuring completion of CRFs. 
If discrepancies are discovered on paper CRFs during monitoring, the Sponsor’s representative will 
ensure that the study staff makes necessary corrections directly to the CRF(s) prior to collection.  
Following CRF collection, the Sponsor will review the data. A Data Clarification Form (DCF) may be 
provided to the site to correct or clarify discrepancies. 
If a site discovers discrepancies after CRF collection, the site may notify the Sponsor and request data 
modification. 
 Data Handling and Record Keeping  
All documents and data shall be produced and maintained in a manner that assures control and 
traceability. 
 Source Data and Documents 
Source data includes information in original records, certified copies of original records of clinical 
findings, observations, or other activities for the study. Source documents for each subject must be 
retained throughout the investigation, including printed or electronic documents containing source 
data. Elements should include: 
• 
Source data and documentation relevant to data recorded for subject screening and CRF 
corroboration. 
• 
Subject records containing the completed ICFs and CRFs   
• 
Regulatory binder containing the protocol and any subsequent amendments, EC submissions 
and approvals, blank ICF(s), and site logs 
• 
Reference manuals containing investigator responsibilities, Sponsor, AE/SAE and informed 
consent guidelines, applicable study aids and training materials, and  
The Principal Investigator or institution shall provide direct access to source data during and after the 
clinical investigation for monitoring, audits, EC review, and regulatory authority inspections.  
 Archiving 
All study data must be archived for the longer of 3 years after study termination or premature 
termination of the clinical trial or as required by current local law. No source documents or study 
records will be destroyed without Sponsor notification and approval. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 31 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
12. MONITORING PLAN 
In collaboration with the site, the Sponsor will ensure proper monitoring of the study to confirm that all 
the research requirements are met. Monitoring visits will oversee the progress of a clinical investigation 
and ensure that it is conducted, recorded, and reported in accordance with the protocol, written 
procedures, Good Clinical Practice (GCP) ISO 14155:2011, and the applicable regulatory requirements. 
 Confidentiality and Data Protection 
The investigator affirms and upholds the principle of the participant's right to privacy, and the 
investigator shall comply with applicable privacy laws. Especially, anonymity of the participants shall be 
guaranteed when presenting the data at scientific meetings or publishing data in scientific journals. 
Individual subject medical information obtained as a result of this study will be considered confidential, 
and disclosure to third parties will be prohibited. Subject confidentiality will be further ensured by 
utilizing subject identification code numbers. For data verification purposes, authorized representatives 
of the Sponsor, a competent authority (CA), or an ethics committee (EC) may require direct access to 
parts of the medical records relevant to the study, including subject medical history. 
 Storage of Images and Associated Health Data 
PET/MR images and associated data will be collected and disclosed to the Sponsor as part of this study. 
Fully de-identified data, which has had all personal identifying information removed, may be stored and 
used by the Sponsor indefinitely. The Sponsor and/or its authorized representatives may use any de-
identified data collected in this study for future technology and engineering development, marketing 
purposes, education, regulatory submissions, publications, or other possible uses. 
 Publication Policy 
The results of this study may be used in future publications as agreed between the Sponsor and site 
conducting the study. The conditions of publication are described in a separate contractual agreement. 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 32 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
REFERENCES 
 
1. ISO. Clinical investigation of medical devices for human subjects - Good Clinical Practice: International 
Organization for Standardization; 2011. ISO 14155:2011(E). 
2. Chen J, Zhao Y, Li X, et al. Imaging primary prostate cancer with 11C-Choline PET/CT: relation to tumour stage, 
Gleason score and biomarkers of biologic aggressiveness. Radiol Oncol. 2012;46(3):179-88. 
3. Ortuño F, Lopez P, Ojeda N, Cervera S. Dysfunctional supplementary motor area implication during attention 
and time estimation tasks in schizophrenia: a PET-O15 water study. 2005;24(2):575-9. 
4. Armbruster M, Sourbron S, Haug A, Zech C. Evaluation of neuroendocrine liver metastases: a comparison of 
dynamic contrast-enhanced magnetic resonance imaging and positron emission tomography/computed 
tomography. Invest Radiol. 2014;49(1). 
5. Kamson D, Mittal S, Buth A, et al. Differentiation of glioblastomas from metastatic brain tumors by tryptophan 
uptake and kinetic analysis: a positron emission tomographic study with magnetic resonance imaging 
comparison. Mol Imaging. 2013;12(5):327–337. 
6. Kitajima K, Suenaga Y, Ueno Y, et al. Value of fusion of PET and MRI in the detection of intra-pelvic recurrence 
of gynecological tumor: comparison with 18F-FDG contrast-enhanced PET/CT and pelvic MRI. Ann Nucl Med. 
2014;28(1):25-32. 
7. G D, Wiesinger F, Sacolick L, et al. Clinical evaluation of zero-echo-time MR imaging for the segmentation of 
the skull. J Nucl Med. 2015;3(417-22):56. 
8. Sun Y, Ventura M, Oosterwijk E, Jansen J, Walboomers F, Heerschap A. Zero Echo Time Magnetic Resonance 
Imaging of Contrast-Agent-Enhanced Calcium Phosphate Bone Defect Fillers. Tissue Eng Part C Methods. 
2013;19(4):281–287. 
9. Center for Devices and Radiological Health (CDRH). Silver Spring, MD: US FDA; 2014. K142098. 
10. Fornell. PET/MRI Enters the U.S. Market. Imaging Tech News. June 2011:1-4. 
11. Brix G, Nekolla E, Nosske D, Griebel J. Risks and safety aspects related to PET/MR examinations. Eur J Nucl 
Med Mol Imaging. 2009;36(S1):S131-8. 
 
 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 33 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
APPENDIX A - STUDY SITE AND INVESTIGATOR LIST  
 The following investigator at the indicated site will be responsible for the conduct of this study:  
Investigator: 1 
 
Principal Investigator 
Bradley J. Kemp, Ph.D.  
Tel:  
1- 507-255-3614 
e-mail:  Kemp.Brad@mayo.edu 
Mayo Clinic 
 
Address:  200 1st St SW 
Rochester, MN 55905 
1 The role of the Principal Investigator is to implement and manage the conduct of the investigation as well as ensure data 
integrity and the rights, safety, and well-being of humans involved in the study [ISO 14155:2011 9.1], as described in this 
protocol.  
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 34 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
APPENDIX B - AMENDMENT TO PROTOCOL VERSION 1.0 TO 2.0 
Purpose: This amendment document describes the changes from protocol version 1.0 to 2.0 to account 
for allowing patient with a pre-existing indication for PET/CT or PET/MR to participate. This does not 
change the safety profile or scientific intent of the study 
The following amendments were made to version 1.0 to produce version 2.0. Point-by-point revisions 
are shown as additions in double-underline (double-underline) and deletions in strikethrough 
(strikethrough) for each change made in this amendment for the previous version.  
Item 
Section 
Revision or Clarification 
Justification 
1 
Study Synopsis: 
Procedures/ 
Methods: 
Adult subjects with pre-existing clinical indications for PET/CT or 
PET/MR with radiotracer injection will be enrolled to undergo 
up to 1 hour of PET/MR scanning within the tracer validity time 
frame in addition toafter their clinically indicated PET/CT or 
PET/MR exam. As part of the study, the corresponding PET/CT 
images will also be collected for ZTE subjects. Images collected 
from the sites will be post-processed outside of the clinical care 
environment by the Sponsor or its delegate using investigational 
MR post-processing software, and resultant images will be read 
by the site for diagnostic acceptability and by independent 
readers for scaled diagnostic image quality, as described in the 
Blinded Reader Evaluation (BIE) plan. The cumulative results of 
this study and concurrent studies of the device conducted by 
the Sponsor may be used to support regulatory submission of 
the devices under study. 
To clarify that subjects with 
indications for PET/MR or 
PET/CT may participate 
(only PET/CT for ZTE 
testing). 
2 
Study Synopsis:  
Eligibility criteria: 
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); 
 
To clarify that subjects with 
indications for PET/MR or 
PET/CT may participate 
(only PET/CT for ZTE 
testing). 
3 
Section 2.1.1 Zero echo 
time (ZTE) Software 
Feature 
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. ZTE functions 
serves a similar clinical purpose as exist ant existent 
visualization techniques (for example Atlas scans).  
 
Typographical correction. 
4 
Section 2.1.2 Q Static (Q. 
MRAC) Software Feature 
In addition, the platform will introduce 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. The planned 
new release of GE SIGNA PET/MR MP26 software platform 
introduces an improved Q.Static feature with Q.MRAC, which 
provides the ability to correct for respiratory motion during the 
MRAC portion of a PET/MR exam. It has the goal to create a 
quiescent (end expiratory) phase PET image with a phase-
matched MR based attenuation correction, which is intended to 
provide more accurate attenuation correction for GE Q.Static 
PET images. 
Added additional detail, as 
suggested by the site. 
5 
Section 2.3.1 
Medications and Biologic 
Products 
No medications or biologic products will be administered as part 
of the study procedures. Prior to participation in the study, 
subjects with clinical indications for PET/CT or PET/MR exams 
Clarifies that patients with 
indications for PET/MR or 
PET/CT may participate, as 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 35 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
will receive their clinically indicated injected radiotracer and any 
other medically necessary medications as ordered by their 
regular physician. Due to the in vivo half-life of radiotracer 
agents, it is reasonably expected that subjects participating in 
the study may have active radiotracer in their bodies during 
their PET/MR scan, but no additional radiotracers will be 
administered as part of the study. No sedatives or contrast 
agents will be administered for research purposes. 
described in Amendments 
#1 and #2. 
6 
Section 2.3.2 Dosimetry 
2.3.2 Dosimetry 
It is important to note that the patient will not receive a second 
radiotracer injection for the research PET/MR study. The 
residual radioactivity from the initial radiotracer injection of the 
clinical PET exam will be adequate.  
Added section to clarify 
that no additional or 
increased dosages will be 
given of radiotracer or 
sedatives for research 
purposes. 
7 
Section 4.1 Study 
Population 
Subjects will be enrolled that have a clinical indication for 
PET/CT or PET/MR with radiotracer injection prescribed for their 
medical care outside of the study. Sites should make reasonable 
attempts to ensure diversity of clinical state (including injury 
severity or extent of disease progression) within the enrolled 
population in order to achieve a sample maximally 
representative of the intended use population. 
Clarifies that patients with 
indications for PET/MR or 
PET/CT may participate, as 
described in Amendments 
#1 and #2. 
8 
Section 4.2.1 Enrollment 
Quota 
Subjects will be enrolled based on a quota block method based 
on scan type (relative to the patient clinical indication for 
PET/CT or PET/MR): 
Clarifies that patients with 
indications for PET/MR or 
PET/CT may participate, as 
described in Amendments 
#1 and #2. 
9 
Section 4.4.1 Inclusion 
Criteria 
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); 
 
To clarify that subjects with 
indications for PET/MR or 
PET/CT may participate 
(only PET/CT for ZTE 
testing). 
10 
Section 4.5 Recruiting 
and Screening 
Subjects will be recruited for potential enrollment in this study 
prior to their clinically indicated PET/CT or PET/MR exam 
according to the institutional procedures of the investigational 
site and its governing IRB. Participants identified after 
completing the their clinically indicated imaging PET/CT exam 
may be recruited, if otherwise eligible and within the study time 
window. All participation will be voluntary, and written 
informed consent will be collected from each participant prior 
to exposure to any investigational devices or procedures. 
Subjects will be screened for enrollment in this study against the 
inclusion and exclusion criteria according to the standard 
procedures of the investigational site. 
Following recruitment, a subject will be considered enrolled (the 
point of enrollment) once he/she signs and dates the informed 
consent form (ICF). Safety events and device issues will, 
however, only be reported during the period of exposure to the 
investigational PET/MR device (from the time the subject enters 
until the time the subject leaves the PET/MR suite), and not for 
clinically indicated imaging (e.g. PET/MR or PET/CT) PET/CT 
procedures that may be observed after the patient provides 
consent but are not a consequence of study participation.  
Once enrolled, the subject will be assigned a unique subject 
number, which will not contain information that could identify 
the subject. The unique subject number will be used to label 
Clarifies that patients with 
indications for PET/MR or 
PET/CT may participate, as 
described in Amendments 
#1 and #2. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 36 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
case report form (CRF) data for the subject throughout his/her 
participation in the study. 
11 
Section 5.1 Activities 
Prior to PET/MR (Pre-
Screen) 
5.1 Activities Prior to PET/MR  
For all subjects, sStudy staff will confirm that the subject is 
eligible and complies with applicable site requirements prior to 
starting study procedures. After the subject completes the ICF, 
he/she will be required to complete certain a two-part pre-
screening procedureactivities to participate in the study. When 
possible, Part 1 should be completed before the subjects PET/CT 
exam. 
5.1.1 Pre-Screening Activities (All Subjects) Part 1 (Before 
PET/CT) 
• 
Verify site institutional policy(ies) for MR safety are 
followed. 
• 
Record implant information for subjects with 
implants allowable per the inclusion/exclusion that 
will be present during scanning (with the exception of 
passive dental filling/implants, surgical clips, or 
surgical staples)*, as follows: 
iv. 
Name of the device 
v. 
Manufacturer of the device 
vi. 
Model Number of the device 
Note: If any or all information is not available, write 
N/A in the applicable area(s) 
• 
Record subject characteristics, as follows: 
v. 
age (in years) 
vi. 
gender 
vii. 
weight 
viii. 
height 
5.1.2 Pre-Screen Part 2 (Activities Afterfor PET/CT 
Subjects) 
• 
Record clinically indicated PET/CT information 
(before the PET/CT scan when possible to limit delay 
time between PET/CT and PET/MR), including start 
and end time of the PET/CT scan and information 
about injected radiotracer, as follows: 
iv. 
radiotracer type, dose and units, and time of 
injection  
v. 
clinical indication for PET/CT scanning 
(oncology, neurology, and/or cardiac etc.) 
vi. 
date and time of PET/CT 
• 
Check for completeness of acquired PET/CT images, if 
a subject is missing required PET/CT images, the 
subject may be withdrawn from the study. PET/CT 
images will be collected as part of the study. 
• 
Check for solid food or insulin administration. If a 
study subject is administered insulin, solid food, or 
any non-water beverage prior to the PET/MR imaging 
that can be expected to interfere with radiotracer 
activity, the subject may be withdrawn from the study 
at the discretion of the investigator if such 
administration(s) could interference with performing 
study procedures and/or radiotracer bioavailability 
during the study period. 
Clarifies which screening 
elements are required for 
all patients and those only 
required for patients 
undergoing PET/CT or 
PET/MR. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 37 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
5.1.3 Part 2 (Activities Required before Study 
PET/MRAfter for All Subjects) 
• 
Encourage subjects to empty their bladder prior to 
PET/MR scanning. 
• 
Provide MR-safe clothing according to participating 
investigational site’s standard procedures, such as 
hospitals gowns, and isolate all non-MR compatible 
equipment or devices and route the devices and/or 
cables as required out of the magnet room. 
• 
Provide mandatory hearing protection, as per site 
institutional procedure. 
 
12 
Section 5.2.1 Subject 
Procedure 
Figure 1. Study procedure for PET/MR scans relative to clinically 
indicated imaging (PET/CT or PET/MR) with injected radiotracer 
*MR Safety Screening and Pre-screening activities identified in 
Section 5.1 Activities Prior to PET/MR (Pre-Screen) should be 
completed prior to the start of the study PET/MR scan. 
 
The research PET/MR scan session will be performed while the 
subject is lying on a scan table. During this time, the subject may 
be asked to shift position to one side or another, lie still and to 
follow simple instructions such as to hold his/her breath at 
specified times.  Subjects may be provided with a calling system 
that allows him or her to contact the Device Operator at any 
time during the scan. While the subject is in the scanner, the 
device operator will remain where the subject is visible (e.g. 
through a window) and audible (e.g. through an intercom). Start 
and end time of research PET/MR scanning and additional 
information will be recorded as per Table 2.  
Modified Figure and 
Caption to reflect that 
PET/MR or PET/CT 
indications may be 
included. 
13 
Appendix A  
Appendix B A – Study Site and Investigator List  
The following investigator at the indicated site will be 
responsible for the conduct of this study:  
 
Invest
igator
: 1 
 
Principal Investigator 
Bradley J. Kemp, Ph.D. 
Robert Witte, MD 
 
Tel: 1- 507-255-3614 
507-284-2511 
 
e-mail: 
Kemp.Brad@mayo.edu 
witte.robert@mayo.edu  
Mayo Clinic 
 
Address:   
200 1st St SW 
Rochester, MN 
55905 
 
 
Corrected typographical 
error in Appendix header. 
 
Added contact information 
for Co-investigator. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 38 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 39 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
APPENDIX C - AMENDMENT TO PROTOCOL VERSION 2.0 TO 3.0 
Purpose: This amendment document describes the changes from protocol version 2.0 to 3.0 to clarify 
that subjects will only receive one type of research exam (ZTE or Q.Static), not both. 
The following amendments were made. Point-by-point revisions are shown as additions in double-
underline (double-underline) and deletions in strikethrough (strikethrough) for each change made in this 
amendment for the previous version.  
Item 
Section 
Revision or Clarification 
Justification 
14 
Study Synopsis: 
Procedures/ 
Methods 
Adult subjects with pre-existing clinical indications for 
PET/CT or PET/MR with radiotracer injection will be enrolled 
to undergo a PET/MR exam lasting up to 1 hour of PET/MR 
scanning (which includes screening and approximately 30 
minutes of scanning) within the tracer validity time frame in 
addition to their clinically indicated exam. During each scan, 
the operator will complete with the ZTE MRAC or Q Static (Q. 
MRAC) research protocol(s) appropriate for the subject’s 
indication. As part of the study, the corresponding PET/CT 
images will also be collected for ZTE subjects. 
Clarified that scan time is 
inclusive of screening and 
scanning. 
15 
Study Synopsis: Study 
duration 
The study is expected to last about 2 months. 
Estimated start date: 01/AugOct/2016 
Estimated end date: 01/OctDec/2016 
Revises anticipated 
start/end dates to reflect 
current timelines. 
16 
Section 1. Background 
and Justification 
This study is being conducted to demonstrate diagnostic 
image quality using the ZTE and Q.Static MRAC features in a 
representative sample of clinical cases requiring head and/or 
whole-body PET/MR scans.  
Corrected terminology for 
consistency with other 
protocol sections. 
17 
Section 2.3.1 
Medications and 
Biologic Products 
No medications or biologic products will be administered as 
part of the study procedures. Prior to participation in the 
study, subjects with clinical indications for PET/CT or PET/MR 
exams will receive their clinically indicated injected 
radiotracer and any other medically necessary medications 
as ordered by their regular physician. Due to the in vivo half-
life of radiotracer agents, it is reasonably expected that 
subjects participating in the study may will have active 
radiotracer in their bodies during their additional research 
PET/MR scan; therefore, but no additional radiotracers will 
be administered as part of the study. No sedatives or 
contrast agents will be administered for research purposes. 
Clarified language for 
transparency regarding 
anticipated incidental 
contrast agent 
administration. There is 
no intended change to 
study design or risk 
profiles based on these 
changes. 
18 
Section 3.3 Summary of 
Study Design 
This is a pre-market, open label, prospective, non-
randomized clinical research study at one site. The study is 
designed to allow for sample PET/MR image collection and 
to demonstrate diagnostic image quality of resultant sample 
image sets from each participating subject. The results of 
this study will be read analyzed according to a prospective 
Blinded Image Evaluation (BIE) plan and Statistical Analysis 
Plan (SAP) prepared by the Sponsor prior to the start of 
image reads. This study is run concurrently with other 
studies of the device conducted by the Sponsor and it is 
prospectively expected that the cumulative results of these 
studies may be used to support regulatory submissions. 
 
Corrected typographical 
error. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 40 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
19 
Section 4.2.1 
Enrollment Quota: 
Table 1 
4.2 Number of Subjects 
The study aims to acquire up to 75 clinical PET/MR image 
sets (up to 38 using subjects will be enrolled to have athe 
ZTE MRAC exam and the remaining 37 subjects will be 
enrolled to have ausing the Q Static (Q. MRAC) 
featuresexam. In the event that a subject scan does not 
produce images, as in the case of withdrawal or technical 
issues preventing scanning, additional subjects may be 
enrolled until the target number is achieved (not to exceed a 
maximum of 75 subjects during the course of the study) as 
described in Section 10.2 - Sample Size Determination. The 
minimum number of necessary subjects will be enrolled to 
achieve the target number of datasets. 
4.2.1 Enrollment Quota 
Subjects will be enrolled based on a quota block method 
based on scan type (relative to the patient clinical indication 
for PET/CT or PET/MR). Each subject may have only one type 
of scan towards these quota blocks (ZTE or Q.Static MRAC), 
not both (Table 1).: 
Table 1. Target quota blocks for subject 
enrollment/target datasets 
Scan Type 
Target number of subject 
datasets 
(NTarget = 30) 
ZTE MRAC 
At least 30 subject scans 
(Nneuro = 30 to 38) 
Q Static  
(Q. MRAC) 
At least 30 subject scans 
(Nbody = 30 to 37) 
 
 
Clarified that subjects will 
only receive one type of 
research exam (ZTE or 
Q.Static), not both, and 
thus may fill only one 
quota block per subject.  
 
Corrected terminology for 
consistency. 
20 
Section 5.1 Activities 
Prior to Research 
PET/MR Exam 
5.1 Activities Prior to Research PET/MR Exam 
 
Clarified that these 
procedures refer to the 
Research PET/MR exam. 
21 
Section 5.1.2 Pre-
Screen Activities for 
PET/CT Subjects 
• 
Record clinically indicated PET/CT information 
(before the PET/CT scan when possible to limit 
delay time between PET/CT and research PET/MR 
exam), including start and end time of the PET/CT 
scan and information about injected radiotracer, as 
follows: 
 
Clarified that these 
procedures refer to the 
Research PET/MR exam. 
22 
Section 5.2 Activities 
during Research 
PET/MR Scanning and 
Data Acquisition 
5.2 Activities during Research PET/MR Scanning and Data 
Acquisition 
5.2.1 Subject Procedure 
The site should perform research PET/MR scans during the 
time that the radiotracer validity time frame. Typically 
research PET/MR exams should be started with 
approximately 4 hours of radiotracer administration; 
however, the site may scan a subject at their discretion is the 
scan is expected to take place during the clinical validity 
window based on the investigator’s expertise (not required 
to be within 4 hours, Fig. 1). This is to ensure sufficient 
radiotracer activity during the investigational procedure. 
… 
Clarified that these 
procedures refer to the 
Research PET/MR exam. 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 41 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
The PET/MR exam may last up to a 1 hour (which includes 
screening and approximately 30 minutes of scanning). Start 
and end time of research PET/MR scanning and additional 
information will be recorded as per Table 2.  
23 
Section 5.2.2 ZTE MRAC 
and Q Static (Q. MRAC) 
PET/MR Scanning 
Procedure 
During each scan, the operator should complete ZTE MRAC 
and/or Q Static (Q. MRAC) protocol(s) appropriate for the 
subject’s indication (both when clinically possible), and 
record the sequence used in the exam. For Q Static (Q. 
MRAC) scans, the site should conduct 5 non-gated MRAC 
acquisitions and 5 gated acquisitions for each subject around 
the lung/abdominal region including the diaphragm. 
Clarifies that subjects will 
only receive one type of 
research exam (ZTE or 
Q.Static) not both. 
24 
Section 5.2.4 Incidental 
Findings 
The additional PET/MR procedures performed in this study 
are for research only and are not intended for diagnostic 
use. Should the device operator observe what they interpret 
to be a potential abnormality, the investigator will evaluate 
the findings and alert the patient if necessary. The 
investigator may recommend diagnostic exams to be 
performed independent of the study. No medical or 
diagnostic care of any kind will be rendered based on study 
image sets using the research PET/MR. 
Clarified that these 
procedures refer to the 
Research PET/MR exam. 
 
 
 

Study Title: Clinical Evaluation Of MP26 Features in Adults 
Study No: 114.03-2016-GES-0001 
 
 
Page 42 of 42 
 
GE MWS DOC1862726 
 
 
Ver: 4.0; 30/Aug/2016 
GE Healthcare – Confidential 
 
APPENDIX D - AMENDMENT TO PROTOCOL VERSION 3.0 TO 4.0 
Purpose: This amendment document describes the changes to a remove legacy element in Table2 that 
inadvertently was included in this version when amendment 3.0 was approved in the Sponsor’s MWS 
documentation system. 
The following amendments were made. Point-by-point revisions are shown as additions in double-
underline (double-underline) and deletions in strikethrough (strikethrough) for each change made in this 
amendment for the previous version.  
Item 
Section 
Revision or Clarification 
Justification 
25 
Section 5.2.2 ZTE MRAC 
and Q Static (Q. MRAC) 
PET/MR Scanning 
Procedure: Table 2 
 
 
 
Coil(s) Used 
Gating 
device(s) used 
Medical tubes 
wires/cables 
Subject 
Motility 
• 3.0T PET/MR 
CMA   
• 3.0T HNU 
• 3.0T UAA  
• 3.0T LAA 
• GEM Flex 
Coil 16-S, M, 
L Array 
• 3.0T Split 
head coil 
• PETMR 8Ch 
HiRes Brain 
Array  
• 3.0T HD Flat 
GEM Table 
Breast Array 
• Other, 
specify 
 
• Respiratory 
bellows 
• ECG leads 
• Peripheral 
gating 
photopulse 
sensor 
 
• None 
• IV 
• Catheterizatio
n 
• Breathing tube 
• Oxygen 
• ECG Monitor 
• Other, specify 
• Walk in on 
own 
• Needs 
wheel chair 
• Lifted onto 
table 
Needs 
assistance 
walking in 
Remove legacy element 
in Table 2 that 
inadvertently was 
included in this version 
when amendment 3.0 
was approved in the 
Sponsor’s MWS 
documentation system. 
 
 
End of Document