Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using the Phillips Cardiac Magnetic Resonance (CMR) Patch
Phase: NA
Conditions: Cardiomyopathies
Sponsor: University of Michigan

Title:  Refinement and Assessment of New MRI Technologies for Cardiovascular Exams Using 
the Phillips Cardiac Magnetic Resonance (CMR) Patch   
 
PI:  Prachi P Agarwal, M.D. 
 
Date of Protocol: 6/4/2021 
Date of IRB Approval: 7/7/2021 
 
NCT #: NCT06331507 

Study Protocol: Refinement and Assessment of New MRI Technologies for Thoracic/ 
Cardiovascular Exams using the Phillips CMR Patch 
 
6/4/2021 
 
Primary Investigator:   
Prachi Agarwal MD   
 
Clinical Professor 
 
Department of Radiology  
 
 
 
Co Investigators: Chest Faculty   
 
 
 
 
 
Thomas L. Chenevert , PhD 
Professor 
 
 
Department of Radiology 
Maryam Ghadimi Mahani, MD 
Assistant Professor  
Department of Radiology 
Suzan, Lowe, RT, R 
 
MRI Technologist 
 
Department of Radiology 
Scott Swanson PhD  
 
Research Investigator 
Department of Radiology 
Venkatesh Murthy MD 
 
Asst. Professor  
 
Department of Radiology 
Nicholas Burris MD  
 
Assistant Professor  
Department of Radiology 
Jimmy Lu MD 
 
 
Asst. Professor 
 
Department of Pediatrics  
Adam Dorfman MD  
 
Assoc. Professor 
 
Department of Cardiology 
Yuxi Pang PhD 
 
 
Research Specialist Sr 
Department of Radiology 
Dariya Malyarenko PhD 
 
Research Investigator 
Department of Radiology 
Nicole Bhave MD 
 
 
Clinical Lecturer 
 
Department of Cardiology 
Sowmya Balasubramanian, MD Assistant Professor  
Department of Pediatrics  
Aparna Joshi, MD                          Assistant Professor  
Department of Radiology 
Frank Bogun MD                           Associate Professor           Department of Cardiology 
 
           
Background: 
 
Magnetic resonance imaging is an extremely flexible modality capable of generating 
high quality images of patient anatomy as well as biophysical measures related to tissue 
composition, function and physiology.  An MRI scanner produces these images by the 
interplay of its two components: hardware and software.  MRI hardware and software 
technologies are still in a state of rapid evolution.  Some evolutional steps only involve 
changes to hardware components of the MRI system.  Many enhancements are 
“software only” and involve alteration of the MRI data acquisition software, or post-
processing software applicable after completion of the MRI exam.  Lastly, some 
developments involve a combination hardware, acquisition software, and post-
processing software all used in concert.  Regardless of its makeup, the new technology 
is designed to improve quality or add content to the MRI data, or improve scan speed 
and patient comfort. 
 
Sophistication and high cost of MRI software/hardware requires that technical 
advancements in MRI will continue to be heavily dependent on engineering provided 
MRI system vendors.  Certainly a key motivation of MRI vendors is commercial success 
of their products.  Nevertheless, MRI vendors realize they do not fully understand the 
medical issues for which their technology is designed, thus they are equally dependent 
on leading medical academic centers for guidance in the technology development 

process.  Indeed, both parties (medical and commercial) fully understand the co-
dependence where clinical application drives new products, and new technology is 
required to 
solve clinical problems.  The proven path to achieve these coupled objectives is via a 
partnership between MRI industry and academic medical centers which have the 
additional scientific and technical infrastructure, as we have within UM Department of 
Radiology. 
 
• The CMR patch is a Philips tested patch that supports multiple cardiac MR 
imaging enhancements compiled from several individual patches generated by 
multiple Philips MR research collaborators. Using both 1.5 and 3T Philips 
scanners. 
• The current revision of the patch has been tested to verify functionality on both 
1.5 and 3T Philips scanners.   
• Michigan Philips scanners that will run the patch have the same scanner 
software release that the Philips used for tesing the CMR patch. 
• The patch does NOT change the non-significant risk classification of the Philips 
MR scanners but is classified as investigational because FDA regulatory 
approval has not been submitted. 
 
 
 
Goals of the Study: 
 
To establish an IRB-approved mechanism to recruit patients to participate in the 
assessment of new MRI technologies designed to improve MRI examinations of the 
chest region that will result in an improvement in patient care. 
 
To allow involved UM faculty to provide de-identified MRI data of these patient scans to 
MRI vendors as descriptive examples of the performance of the new technology. 
 
To allow involved UM faculty to present and publish de-identified MRI data of these 
patient scans in reports regarding the performance of the new technology at scientific 
meetings in radiology/MRI journals. 
 
Objectives : 
Philips MR is releasing a cardiac imaging patch (CMR) that is a compilation of functionality 
supported by multiple patches produced by multiple Philips cardiac MR researchers. Philips is 
providing the patch to the PI to improve support of ongoing cardiac MR studies under IRB 
protocol. The patch will also support pending grant submissions by the PI. The PI will also 
submit conference submissions, manuscripts and provide Philips feedback on the clinical utility 
of the various techniques and workflow enhancements supported by the CMR patch.  
The cardiac patch is the improved version of sequences that we use in our routine clinical 
practice that will improve the quality of our images and yield improved diagnosis for our patients. 
The scientists at Philips have worked to improve our service and answer our need. For example, 

we have used one patch in the past to minimize the artifact of ICD to allow us to identify 
myocardial scar that would have been otherwise obscured by the artifact. 
 
These are all software updates that we will continue using them. These patches are for cardiac 
imaging 
 
The patch is specific to improve current cardiac imaging sequences. Cardiac imaging is very 
tricky and the images are degraded by respiratory and cardiac motion. The scanning is lengthy 
and we are trying to improve sequences and make them easy on the patients with after 
scanning.  
 
These cardiac applications are designed for cardiac imaging of cardiac vascular diseases. 
These particular sequences are not going to be used for different body parts.  
 
If we identify a clinical need to investigate other sequences that are not currently part of this 
patch we will amend the protocol.  
 
Once we identify that particular sequences are providing improved imaging compared to older 
version of the sequence we have, then we will modify our clinical imaging protocol accordingly to 
better answer clinical care..  
 
Significance: 
 
Increasing the quality and content of chest MRI examinations will aid diagnosis.   Scan 
speed enhancements will improve patient throughput, comfort and compliance.  Any 
and all of these technical enhancements can improve management of our current 
patients, as well as have a positive impact on future clinical MRI procedures. 
 
 
Risks: 
The patch does not change the non-significant risk classification of the Philips MR 
scanners but is classified as investigational because FDA regulatory approval has not 
been submitted. 
 
This new technology to be studied will be operated within established safety guidelines 
for MRI scanning.  Risks associated with the new technologies will be limited to be no 
greater than risk associated with standard clinical MRI scanning.  Inherent within the 
operating system and hardware of the MRI scanner are built-in safety constraints 
 
Benefits: 
 
Using this new technology is designed to improve quality of images looking for heart 
muscle damage. 
 
Statistical analysis of results: 

Assessment of the new technologies will be quantified by a variety of performance and 
image quality/content measures.  The appropriate set of measures will selected based 
on specific features offered by each assessed technology, but will drawn from the 
following quantities: 
1) Scan speed:   Scan speed is time required to set-up and run the new technique 
relative to the standard method. 
2) industry and academic medical centers which have the additional scientific and 
technical infrastructure, as we have within UM Department of Radiology. 
 
 
Goals of the study: 
 
To establish an IRB-approved mechanism to recruit patients to participate in the 
assessment of new MRI technologies the (Phillips CMR Patch) which is post processing 
software designed to improve MRI examinations of the chest region that will result in an 
improvement in patient care. 
 
To allow involved UM faculty to provide de-identified MRI data of these patient scans to 
MRI vendors as descriptive examples of the performance of the new technology. 
 
To allow involved UM faculty to present and publish de-identified MRI data of these 
patient scans in reports regarding the performance of the new technology at scientific 
meetings in radiology/MRI journal 
 
Confidentiality: 
 
All patient data (i.e. MR images) will be electronically de-identified prior to their inclusion 
in reports, charts, and slide presentations sent to the MRI vendor.  Any clinical 
information provided with the images will be limited to: patient age, sex, weight, and 
disease diagnosis (eg. myocardial infarct).  Additionally, these data will be compiled and 
evaluated by UM Faculty for quality control and trends.  In any case, all study logs and 
databases will be kept in a locked and secure area within the Department of Radiology 
by the PI. 
 
 
Experimental Design: 
 
500 patients who will have a clinically ordered MRI will be recruited for this study.  Male 
and non-pregnant female patients, age 18 years or older, of all ethnic backgrounds 
presenting for a clinically-ordered cardiac MRI exams will be eligible.   
 
When a patient presents for a clinically indicated cardiac MRI examination a member of 
the study team will approach the patient prior to their exam.  Pre-screening of MRI 
schedules by a study team member will identify potential subjects.  If a patient is 
interested in participating, a member of the study team will provide the patient with a copy 
of the informed consent.  Sufficient time will be allowed to each individual to read the 

consent, and have all questions answered prior to the signing of the document. Clinical 
patients complete a safety questionnaire as part of their clinically ordered MRI.  
Women interested in participating in this study as patients will be screened for pregnancy 
following standard clinical practices for all MRI studies at University of Michigan, these 
include screening for pregnancy by questionnaire.  
 
 
Inclusion Criteria 
 
Adult patients undergoing clinical MRI 
 
Exclusion Criteria 
 
Patients with contraindication to MRI