P41EB031771
Project Grant
Overview
Grant Description
MRI Resource for Physiologic, Metabolic and Anatomic Biomarkers - Summary
The importance of biomarkers in clinical practice and regulatory science is difficult to overstate. The ultimate goal for clinical care of the future is to determine the most appropriate therapy for each patient's unique version of a particular disease. This concept of precision medicine has been identified as a national priority in the USA, leading to a need for biomarkers that can provide objective and reproducible information.
In addition, regulatory science for the approval of new qualified drugs and medical technologies has an urgent need for qualified biomarkers to report on the success or failure of these drugs and technologies. Imaging biomarkers, providing in situ "biopsies", have the potential to provide such specific information and, ultimately, to improve routine clinical care and speed up development of new treatments.
The overall goal of this resource, therefore, is to develop novel noninvasive MRI candidate biomarkers that can ultimately be used for:
(I) Personalized assessment of patients for diagnosis, prognosis, and treatment monitoring;
(II) Monitoring of the development of new medical technologies and drugs, i.e. for better guiding of clinical trials.
The significance of our proposed developments lies in providing the fundamental design and initial testing (i.e. not clinical trials itself) of new MRI candidate biomarkers with the potential to provide surrogate quantitative imaging endpoints that are as close as possible to clinical endpoints.
As such, this resource will focus on designing, calibrating, and standardizing new magnetic resonance (MR) technologies to provide reliable measures across sessions, scanners, and raters. This technology will then be disseminated for larger scale patient studies to allow clinical validation.
The MRI Resource for Physiologic, Metabolic and Anatomic Biomarkers is an interdepartmental and interdisciplinary consortium combining facilities and expertise of the F.M. Kirby Research Center at Kennedy Krieger Institute (KKI), the Department of Radiology at Johns Hopkins University (JHU) School of Medicine, the Center for Imaging Science at the JHU Whiting School of Engineering, and the Department of Biostatistics at the JHU Bloomberg School of Public Health.
We propose 4 TRD projects, 3 on MR acquisition approaches and one bringing them together with advanced multi-scale data analysis methods that include machine learning. To assure a proper choice of technologies, we will interact closely with a group of clinical and research experts in a push-pull relationship through collaborative projects (CPS) that focus on brain diseases, disorders, and injuries that have a need for new quantitative MR technology to better and noninvasively assess them.
These include anemia/ischemia and related white matter hyperintensity lesions (CPS 1,5), aging, cerebrovascular disease, and dementia (CPS 2,7,10), traumatic brain injury (CP4), glymphatic function (CP6), pain (CP8), and addiction (CP9).
As an initial testbed for our methods, we also have a group of service projects (SPS) to which we will provide both data acquisition methods and data analysis software. Finally, we will train investigators in their use and disseminate methods nationwide and to MRI manufacturers for even broader application.
The importance of biomarkers in clinical practice and regulatory science is difficult to overstate. The ultimate goal for clinical care of the future is to determine the most appropriate therapy for each patient's unique version of a particular disease. This concept of precision medicine has been identified as a national priority in the USA, leading to a need for biomarkers that can provide objective and reproducible information.
In addition, regulatory science for the approval of new qualified drugs and medical technologies has an urgent need for qualified biomarkers to report on the success or failure of these drugs and technologies. Imaging biomarkers, providing in situ "biopsies", have the potential to provide such specific information and, ultimately, to improve routine clinical care and speed up development of new treatments.
The overall goal of this resource, therefore, is to develop novel noninvasive MRI candidate biomarkers that can ultimately be used for:
(I) Personalized assessment of patients for diagnosis, prognosis, and treatment monitoring;
(II) Monitoring of the development of new medical technologies and drugs, i.e. for better guiding of clinical trials.
The significance of our proposed developments lies in providing the fundamental design and initial testing (i.e. not clinical trials itself) of new MRI candidate biomarkers with the potential to provide surrogate quantitative imaging endpoints that are as close as possible to clinical endpoints.
As such, this resource will focus on designing, calibrating, and standardizing new magnetic resonance (MR) technologies to provide reliable measures across sessions, scanners, and raters. This technology will then be disseminated for larger scale patient studies to allow clinical validation.
The MRI Resource for Physiologic, Metabolic and Anatomic Biomarkers is an interdepartmental and interdisciplinary consortium combining facilities and expertise of the F.M. Kirby Research Center at Kennedy Krieger Institute (KKI), the Department of Radiology at Johns Hopkins University (JHU) School of Medicine, the Center for Imaging Science at the JHU Whiting School of Engineering, and the Department of Biostatistics at the JHU Bloomberg School of Public Health.
We propose 4 TRD projects, 3 on MR acquisition approaches and one bringing them together with advanced multi-scale data analysis methods that include machine learning. To assure a proper choice of technologies, we will interact closely with a group of clinical and research experts in a push-pull relationship through collaborative projects (CPS) that focus on brain diseases, disorders, and injuries that have a need for new quantitative MR technology to better and noninvasively assess them.
These include anemia/ischemia and related white matter hyperintensity lesions (CPS 1,5), aging, cerebrovascular disease, and dementia (CPS 2,7,10), traumatic brain injury (CP4), glymphatic function (CP6), pain (CP8), and addiction (CP9).
As an initial testbed for our methods, we also have a group of service projects (SPS) to which we will provide both data acquisition methods and data analysis software. Finally, we will train investigators in their use and disseminate methods nationwide and to MRI manufacturers for even broader application.
Funding Goals
TO SUPPORT HYPOTHESIS-, DESIGN-, TECHNOLOGY-, OR DEVICE-DRIVEN RESEARCH RELATED TO THE DISCOVERY, DESIGN, DEVELOPMENT, VALIDATION, AND APPLICATION OF TECHNOLOGIES FOR BIOMEDICAL IMAGING AND BIOENGINEERING. THE PROGRAM INCLUDES BIOMATERIALS (BIOMIMETICS, BIOPROCESSING, ORGANOGENESIS, REHABILITATION, TISSUE ENGINEERING, IMPLANT SCIENCE, MATERIAL SCIENCE, INTERFACE SCIENCE, PHYSICS AND STRESS ENGINEERING, TECHNOLOGY ASSESSMENT OF MATERIALS/DEVICES), BIOSENSORS/BIOTRANSDUCERS (TECHNOLOGY DEVELOPMENT, TECHNOLOGY ASSESSMENT, DEVELOPMENT OF ALGORITHMS, TELEMETRY), NANOTECHNOLOGY (NANOSCIENCE, BIOMIMETICS, DRUG DELIVERY SYSTEMS, DRUG BIOAVAILABILITY, MICROARRAY/COMBINATORIAL TECHNOLOGY, GENETIC ENGINEERING, COMPUTER SCIENCE, TECHNOLOGY ASSESSMENT), BIOINFORMATICS (COMPUTER SCIENCE, INFORMATION SCIENCE, MATHEMATICS, BIOMECHANICS, COMPUTATIONAL MODELING AND SIMULATION, REMOTE DIAGNOSIS AND THERAPY), IMAGING DEVICE DEVELOPMENT, BIOMEDICAL IMAGING TECHNOLOGY DEVELOPMENT, IMAGE EXPLOITATION, CONTRAST AGENTS, INFORMATICS AND COMPUTER SCIENCES RELATED TO IMAGING, MOLECULAR AND CELLULAR IMAGING, BIOELECTRICS/BIOMAGNETICS, ORGAN AND WHOLE BODY IMAGING, SCREENING FOR DISEASES AND DISORDERS, AND IMAGING TECHNOLOGY ASSESSMENT AND SURGERY (TECHNIQUE DEVELOPMENT AND TECHNOLOGY DEVELOPMENT).
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Baltimore,
Maryland
212051832
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 305% from $1,598,115 to $6,467,103.
Hugo W. Moser Research Institute At Kennedy Krieger was awarded
MRI Biomarkers for Precision Medicine
Project Grant P41EB031771
worth $6,467,103
from the National Institute of Biomedical Imaging and Bioengineering in July 2021 with work to be completed primarily in Baltimore Maryland United States.
The grant
has a duration of 4 years 9 months and
was awarded through assistance program 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health.
The Project Grant was awarded through grant opportunity National Centers for Biomedical Imaging and Bioengineering (NCBIB) (P41 Clinical Trials Optional).
Status
(Ongoing)
Last Modified 4/4/25
Period of Performance
7/1/21
Start Date
4/30/26
End Date
Funding Split
$6.5M
Federal Obligation
$0.0
Non-Federal Obligation
$6.5M
Total Obligated
Activity Timeline
Transaction History
Modifications to P41EB031771
Additional Detail
Award ID FAIN
P41EB031771
SAI Number
P41EB031771-1672878448
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Nonprofit With 501(c)(3) IRS Status (Other Than An Institution Of Higher Education)
Awarding Office
75N800 NIH National Institute of Biomedical Imaging and Bioengineering
Funding Office
75N800 NIH National Institute of Biomedical Imaging and Bioengineering
Awardee UEI
DKMDCB5HNBL7
Awardee CAGE
47VT8
Performance District
MD-07
Senators
Benjamin Cardin
Chris Van Hollen
Chris Van Hollen
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Health and Human Services (075-0898) | Health research and training | Grants, subsidies, and contributions (41.0) | $2,434,494 | 100% |
Modified: 4/4/25