SBIR-STTR Award

Towards intra-operative guidance in brain tumor surgery using real-time resting-state functional MRI
Award last edited on: 2/7/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NINDS
Total Award Amount
$378,233
Award Phase
1
Solicitation Topic Code
853
Principal Investigator
Dieter W Dennig

Company Information

Neurinsight LLC

1616 Bayita Lane Nw
Albuquerque, NM 87107
Location: Single
Congr. District: 01
County: Bernalillo

Phase I

Contract Number: 1R42NS134505-01
Start Date: 9/19/2023    Completed: 8/31/2024
Phase I year
2023
Phase I Amount
$378,233
Resting-state functional MRI (rsfMRI) is a rapidly developing task-free approach for presurgical mapping. It can complement task-based functional MRI (tfMRI) in patients who have difficulties performing tasks and efficiently map resting state networks (RSNs) in regions that are not typically mapped with tfMRI due to time constraints, such as frontal cortex. It has the potential to provide iterative intra-operative guidance duringprogressive resection, enables connectome mapping in anesthetized patients, and holds promise forintra-operative guidance of minimally invasive surgery where intra-operative electrocortical mapping may not bepossible. To achieve clinical acceptance, rsfMRI analysis needs to be highly tolerant to head movement,physiological signal pulsation, lesion-related changes of functional neuro-anatomy and cerebrovascularuncoupling; and provide data quality control metrics during the ongoing scan. Intra-operative guidanceadditionally requires automated online mapping of RSNs and tolerance to intra-operative brain shifts. There are currently no FDA-approved rsfMRI tools available for presurgical mapping. Here, we propose afully automated, highly sensitive and cost-effective real-time rsfMRI analysis technology on a high-performanceworkstation for presurgical and intraoperative mapping. The project builds on TurboFIRE, a powerful real-timetfMRI and rsfMRI analysis software tool for high-speed fMRI, the success of a prior Phase I STTR study in 12brain tumor patients that showed clinically acceptable concordance of real-time high-speed multi-echo rsfMRIwith tfMRI, and intra-operative electrocortical stimulation (ECS); and our experience with intra-operative rsfMRIin anesthetized brain tumor patients. This technology provides online rsfMRI mapping, eliminatingtime-consuming postprocessing, and seamless integration into presurgical planning and intra-operative MRI.This methodology will have significant clinical and commercial potential for a wide range ofneurological and psychiatric applications beyond pre-surgical mapping in patients with brain tumors. Itopens up functional brain mapping to patient populations that have been difficult to study in the past.

Public Health Relevance Statement:
NARRATIVE Surgical removal of brain tumors requires a delicate balance between maximum resection of the tumor and maximum preservation of neurological function, also known as maximum safe resection. Resting-state functional Magnetic Resonance Imaging (MRI) is a rapidly developing approach for presurgical mapping of cortical brain function that does not require patient participation. It can complement task-based functional MRI in patients who have difficulties performing tasks and can efficiently map a large number of functional brain systems to guide surgery. It replaces traditional approaches of functional MRI that require patient participation in patients with functional impairment and holds considerable promise for intra-operative guidance of minimally invasive surgery. There is currently no FDA-approved resting-state functional Magnetic Resonance Imaging software tool for presurgical mapping. Here, we propose a fully automated, highly sensitive and cost-effective real-time resting-state functional Magnetic Resonance Imaging analysis software tool on a custom high-performance computer workstation for presurgical and intraoperative mapping of cortical brain function, building on TurboFIRE, a powerful real-time rtfMRI and sfMRI analysis software tool and the success of a prior Phase I STTR program. This approach meets urgent clinical needs and has high commercial potential for seamlessly integrating resting-state functional Magnetic Resonance Imaging into the clinical workflow of presurgical planning and intra-operative MRI.

Project Terms:

Phase II

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