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U01EB034313

Cooperative Agreement

Overview

Grant Description
Enabling clinical tissue microstructure imaging as a diagnostic tool in wide-bore 3T MRI - Project Summary/Abstract

Definitive characterization of cytoarchitecture and its alteration is key to clinical diagnosis and patient management in disease, including cancer. Current standard-of-care of such microstructure characterization is based primarily on histopathological assessment via biopsy sampling of suspected lesions. However, invasive biopsy procedures carry burdens of procedure complexity, sampling errors, and complications.

Thus, it is desirable to have a non-invasive, high-sensitivity, high-specificity imaging tool that accurately assesses tumor microstructures that are comparable to that obtained from biopsy/histopathology. This will have the clinically significant result of reducing unnecessary biopsies at the minimum, and perhaps reduce the overall number of biopsy procedures and repeat biopsies. Furthermore, this will significantly improve the precision of biopsy to sample clinically significant cancers and regions most relevant to cancer prognosis.

We propose to apply advanced diffusion MRI (dMRI), including novel oscillating gradient spin echo (OGSE) diffusion encoding, for tumor microstructure imaging and the pilot application will be to improve characterization of the epithelium, stroma, and lumen volume fractions which are highly correlated to prostate cancer grades. OGSE dMRI has been attempted in clinical whole-body MRI but the technique has had only modest success due to the limited gradient performance of whole-body MRI scanners.

The gradient amplitude and slew rate of existing clinical whole-body 3.0T MRI scanners are often constrained by peak power of the gradient driver. Many clinical 70-cm wide-bore MRI systems operate at 1 MVA peak power, while some high-end systems increase the peak power to 2-2.7 MVA. However, the 2-3x higher peak power substantially increases the overall cost of MRI systems and requires major increases to the hospital's electrical service and cooling infrastructure to accommodate increased electrical power and thermal loads. Consequently, such upgrades become cost prohibitive and are impractical for wide adoption.

Our technical solution is to build a new 4 MVA silicon carbide (SiC) semiconductor gradient driver which replaces a conventional silicon 1 MVA or 2 MVA gradient driver in clinical 3.0T wide-bore MRI scanners without requiring any changes to facility infrastructure. We have assembled a diverse, multi-disciplinary team from GE Research, Memorial Sloan Kettering Cancer Center, and Stanford University to develop MRI tools and methods to address clinical needs of non-invasive tumor microstructure imaging to solve clinically significant problems in cancer.

We will demonstrate tumor microstructure imaging enabled by higher gradient amplitude and slew rate can provide clinical diagnostic information on tumor characterization comparable to that obtained from biopsy and move closer to the goal of reducing unnecessary biopsies. We will demonstrate the clinical significance in prostate cancer, as it is the second leading cause of death in men. It is applicable to other cancers and a broad range of clinical applications where non-invasive tumor microstructure characterization will significantly improve patient management.
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).
Place of Performance
Schenectady, New York 123091027 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 189% from $1,088,192 to $3,149,533.
GE Medical Systems Information Technologies was awarded Non-Invasive Tumor Microstructure Imaging Improved Cancer Diagnosis Cooperative Agreement U01EB034313 worth $3,149,533 from the National Institute of Biomedical Imaging and Bioengineering in September 2023 with work to be completed primarily in Schenectady New York United States. The grant has a duration of 5 years and was awarded through assistance program 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health. The Cooperative Agreement was awarded through grant opportunity Bioengineering Partnerships with Industry (U01 Clinical Trial Optional).

Status
(Ongoing)

Last Modified 8/20/25

Period of Performance
9/1/23
Start Date
8/31/28
End Date
39.0% Complete

Funding Split
$3.1M
Federal Obligation
$0.0
Non-Federal Obligation
$3.1M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to U01EB034313

Transaction History

Modifications to U01EB034313

Additional Detail

Award ID FAIN
U01EB034313
SAI Number
U01EB034313-1485260812
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
For-Profit Organization (Other Than Small Business)
Awarding Office
75N800 NIH National Institute of Biomedical Imaging and Bioengineering
Funding Office
75N800 NIH National Institute of Biomedical Imaging and Bioengineering
Awardee UEI
G2JTZ3UQV9M3
Awardee CAGE
9G8T4
Performance District
NY-20
Senators
Kirsten Gillibrand
Charles Schumer

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) $1,088,192 100%
Modified: 8/20/25