R01CA258788
Project Grant
Overview
Grant Description
A comprehensive clinical fMRI software solution to enable mapping of critical functional networks and cerebrovascular reactivity in the brain - Project Summary.
Functional localization of eloquent brain areas for patients undergoing surgery for brain tumors, epilepsy, or other neurological diseases is crucial to prevent post-surgical deficits and reduce morbidity. Task-based (TB) functional MRI (fMRI), which detects blood oxygenation level-dependent (BOLD) signal changes while a patient performs task paradigms, is a standard-of-care clinical procedure for presurgical mapping of eloquent cortices.
Two major limitations of clinical TB-fMRI are a patient's inability to perform the task and lesion-induced impairment of neurovascular coupling (which drives the BOLD signal). Resting-state (RS) fMRI, which measures synchronized BOLD signal oscillations during rest, can be used to map brain networks with minimal requirements for patient compliance and has been demonstrated to accurately localize motor and language areas for presurgical planning.
Cerebrovascular reactivity (CVR) mapping, accessed by dynamic BOLD imaging during a hypercapnia task such as breath-holding, can be used to identify areas with potential false-negative fMRI results due to neurovascular uncoupling (NVU) and has been suggested as an emerging standard to be used with clinical fMRI.
Currently, there are no commercially available FDA-cleared software tools for localizing the resting-state networks (RSNs) or CVR. Clinical investigators have relied on research software packages that are either not clinically integrated or not yet optimized and validated in large patient populations. Thus, a vetted software solution is urgently needed to enable these state-of-the-art fMRI methods to benefit patients beyond the limitations of TB-fMRI.
We hypothesize that enhancing, optimizing, and validating our preliminary software and integrating it with an established commercial fMRI platform will create robust solutions for clinical mapping of RSN and CVR. Through three specific aims, the software solutions will be optimized and tested with RS-fMRI and CVR datasets from approximately 350 patients with brain tumors or epilepsy at three institutions.
Aim 1 is to create the software for mapping RSNS and determine optimized workflows for localizing eloquent areas including primary visual, motor (hands, tongue, and feet), and language (primary and secondary) areas. Both seed-based correlation and independent component analysis will be incorporated.
Aim 2 is to create the software for mapping CVR and determine the optimized workflow for identifying and visualizing brain areas with potential false-negative fMRI results. The software will include a multiple-latency general linear model and a unique graphical user interface to visualize the NVU.
Aim 3 is to test and validate the software with presurgical fMRI datasets. The results will be compared against those obtained from (1) processed using widely used research software packages, (2) TB-fMRI, and (3) intraoperative direct cortical stimulation.
This research is anticipated to create robust and clinically available software that will greatly increase the patient population who can benefit from presurgical fMRI and will improve confidence in functional localization for surgical planning. This will directly benefit patients by preserving their post-surgical functions while allowing surgeons to safely maximize the resection of brain lesions.
Functional localization of eloquent brain areas for patients undergoing surgery for brain tumors, epilepsy, or other neurological diseases is crucial to prevent post-surgical deficits and reduce morbidity. Task-based (TB) functional MRI (fMRI), which detects blood oxygenation level-dependent (BOLD) signal changes while a patient performs task paradigms, is a standard-of-care clinical procedure for presurgical mapping of eloquent cortices.
Two major limitations of clinical TB-fMRI are a patient's inability to perform the task and lesion-induced impairment of neurovascular coupling (which drives the BOLD signal). Resting-state (RS) fMRI, which measures synchronized BOLD signal oscillations during rest, can be used to map brain networks with minimal requirements for patient compliance and has been demonstrated to accurately localize motor and language areas for presurgical planning.
Cerebrovascular reactivity (CVR) mapping, accessed by dynamic BOLD imaging during a hypercapnia task such as breath-holding, can be used to identify areas with potential false-negative fMRI results due to neurovascular uncoupling (NVU) and has been suggested as an emerging standard to be used with clinical fMRI.
Currently, there are no commercially available FDA-cleared software tools for localizing the resting-state networks (RSNs) or CVR. Clinical investigators have relied on research software packages that are either not clinically integrated or not yet optimized and validated in large patient populations. Thus, a vetted software solution is urgently needed to enable these state-of-the-art fMRI methods to benefit patients beyond the limitations of TB-fMRI.
We hypothesize that enhancing, optimizing, and validating our preliminary software and integrating it with an established commercial fMRI platform will create robust solutions for clinical mapping of RSN and CVR. Through three specific aims, the software solutions will be optimized and tested with RS-fMRI and CVR datasets from approximately 350 patients with brain tumors or epilepsy at three institutions.
Aim 1 is to create the software for mapping RSNS and determine optimized workflows for localizing eloquent areas including primary visual, motor (hands, tongue, and feet), and language (primary and secondary) areas. Both seed-based correlation and independent component analysis will be incorporated.
Aim 2 is to create the software for mapping CVR and determine the optimized workflow for identifying and visualizing brain areas with potential false-negative fMRI results. The software will include a multiple-latency general linear model and a unique graphical user interface to visualize the NVU.
Aim 3 is to test and validate the software with presurgical fMRI datasets. The results will be compared against those obtained from (1) processed using widely used research software packages, (2) TB-fMRI, and (3) intraoperative direct cortical stimulation.
This research is anticipated to create robust and clinically available software that will greatly increase the patient population who can benefit from presurgical fMRI and will improve confidence in functional localization for surgical planning. This will directly benefit patients by preserving their post-surgical functions while allowing surgeons to safely maximize the resection of brain lesions.
Funding Goals
TO IMPROVE SCREENING AND EARLY DETECTION STRATEGIES AND TO DEVELOP ACCURATE DIAGNOSTIC TECHNIQUES AND METHODS FOR PREDICTING THE COURSE OF DISEASE IN CANCER PATIENTS. SCREENING AND EARLY DETECTION RESEARCH INCLUDES DEVELOPMENT OF STRATEGIES TO DECREASE CANCER MORTALITY BY FINDING TUMORS EARLY WHEN THEY ARE MORE AMENABLE TO TREATMENT. DIAGNOSIS RESEARCH FOCUSES ON METHODS TO DETERMINE THE PRESENCE OF A SPECIFIC TYPE OF CANCER, TO PREDICT ITS COURSE AND RESPONSE TO THERAPY, BOTH A PARTICULAR THERAPY OR A CLASS OF AGENTS, AND TO MONITOR THE EFFECT OF THE THERAPY AND THE APPEARANCE OF DISEASE RECURRENCE. THESE METHODS INCLUDE DIAGNOSTIC IMAGING AND DIRECT ANALYSES OF SPECIMENS FROM TUMOR OR OTHER TISSUES. SUPPORT IS ALSO PROVIDED FOR ESTABLISHING AND MAINTAINING RESOURCES OF HUMAN TISSUE TO FACILITATE RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Houston,
Texas
770304009
United States
Geographic Scope
Single Zip Code
Related Opportunity
Analysis Notes
Amendment Since initial award the total obligations have increased 306% from $402,421 to $1,633,007.
The Univeristy Of Texas M.D. Anderson Cancer Center was awarded
Project Grant R01CA258788
worth $1,633,007
from National Cancer Institute in March 2022 with work to be completed primarily in Houston Texas United States.
The grant
has a duration of 5 years and
was awarded through assistance program 93.394 Cancer Detection and Diagnosis Research.
The Project Grant was awarded through grant opportunity Academic-Industrial Partnerships for Translation of Technologies for Diagnosis and Treatment (R01 - Clinical Trial Optional).
Status
(Ongoing)
Last Modified 2/20/25
Period of Performance
3/21/22
Start Date
2/28/27
End Date
Funding Split
$1.6M
Federal Obligation
$0.0
Non-Federal Obligation
$1.6M
Total Obligated
Activity Timeline
Subgrant Awards
Disclosed subgrants for R01CA258788
Transaction History
Modifications to R01CA258788
Additional Detail
Award ID FAIN
R01CA258788
SAI Number
R01CA258788-908956045
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Public/State Controlled Institution Of Higher Education
Awarding Office
75NC00 NIH NATIONAL CANCER INSTITUTE
Funding Office
75NC00 NIH NATIONAL CANCER INSTITUTE
Awardee UEI
S3GMKS8ELA16
Awardee CAGE
0KD38
Performance District
TX-09
Senators
John Cornyn
Ted Cruz
Ted Cruz
Budget Funding
Federal Account | Budget Subfunction | Object Class | Total | Percentage |
---|---|---|---|---|
National Cancer Institute, National Institutes of Health, Health and Human Services (075-0849) | Health research and training | Grants, subsidies, and contributions (41.0) | $776,122 | 100% |
Modified: 2/20/25