SOW- MRI Scanning at UW2-9.docx

STATEMENT OF WORK

1.0 Contract Title: MRI Scanning and analysis at the University of Washington

2.0 Background:

The Department of Veterans Affairs has recently been awarded VA CSDR 1I01CX003005-01 “Development of AI assisted intra- and extra-cranial artery vessel wall imaging and analysis techniques for characterization of high-risk cerebral vascular atherosclerosis”, which is a multisite IRB, teaming up with the Puget Sound VA Medical Center and the University of Washington for MRI scanning. The University of Washington has unique expertise to develop sequences, platforms and analysis tools needed to improve MRI research and complete the goals defined by the approved merit grant. Currently, the Salt Lake City VA Medical Center (SLC VAMC) does not provide the needed analysis tools, new protocols, or sequences due to not having the expertise required, or analysis software tools.

Leveraging the partnership between the two organizations will bolster the quality and quantity of research being conducted at VA and is critical to the mentioned research protocol at the SLC VAMC.

Extracranial and intracranial carotid artery disease are responsible for approximately 60% of ischemic strokes in veterans. Independently, carotid and intracranial magnetic resonance imaging (MRI) can identify plaque features associated with a higher risk for stroke. There is a compelling need to develop efficient but comprehensive carotid and intracranial vessel wall imaging protocols and standardized image analysis techniques to identify and categorize these cerebrovascular lesions. An efficient combined carotid-brain vessel wall MRI protocol to assess both carotid and intracranial plaque is needed. The approved protocol will develop combined head and neck coils and sequences that provide rapid, detailed plaque imaging and are compatible with multiple MRI platforms using artificial intelligence (AI) based technology to far better image, categorize, and diagnose the culprit plaque responsible for ischemic stroke, laying the foundation for studies targeting stroke prevention.

Software development has been an important contributor to the success of the University of Washington Vascular Imaging Laboratory (VIL) in atherosclerosis imaging and clinical trials. Detailed documentation of standard operating procedures for software development and maintaining the software life cycle has been established. Development contributes to three core products. The first is the Vascular Trials System (VTS) which is a 21 CFR part 11 (FDA) compliant trial management system for imaging-based trials of vascular therapies. The second is the iCafe toolbox, a series of artificial intelligence and image processing tools for quantifying intracranial vasculature features through automated artery centerline tracing, multi-sequence registration and image reformation and visualization. The third is CASCADE, a dedicated software tool for vessel wall MRI analysis, consisting of algorithms for multispectral display and registration, automated segmentation, and visualization. Fourth is MOCHA, a novel multi-contrast, multi-time point intracranial and extracranial vessel wall analysis software for measurement of different arterial segments of the intracranial vasculature and carotid arteries. This study will use these core products for data analysis and quantification.

3.0 Scope:

3.1 The vendor is to provide MRI protocol development, 3T MRI scans, and analysis of MRI scans.

3.2 3T MRI scans will be completed annually with the expectation of imaging recruitment and technical development services, and imaging analysis.

3.2.1 Billable line items include: MRI scans, technical development services, recruitment services, and image analysis services as described below.

3.3 A minimum specification of the MRI machines

Additional Information/Requirements:

3.3.1 MRI machines need to have an MRI combined head and neck coils for Siemens or Philips MRI scanners.

3.4 3T MRI Scanning

3.4.1 MR Imaging at the University of Washington (UW) will be conducted at the Bio-Molecular Imaging Center (BMIC) under the direction of site PI,.

3.4.2 Scans shall be completed using the BMIC 3T Philips Ingenia 3.0T CX (Software Release 5.4.1) whole body scanner.

3.4.2.1 This scanner is available full time for research.

3.4.2.2 This scanner also includes the Philips IntelliSpace Portal (Software Release 7.0), which provides advanced image post-processing software.

3.4.3 BMIC shall provide space for subject interviews and physical examinations.

3.4.4 A Philips clinical scientist with Philips Medical Systems credentials shall be located on site and available to support new sequence development on 3T Philips Ingenia CX scanner.

3.4.4.1 The clinical scientist shall also provide all sequence source code and the proprietary sequence development environment.

3.5 Image Analysis Services

3.5.1 The Vascular Imaging Laboratory (VIL) is the location where all image- related analysis and final study evaluations will be conducted. The VIL is 3000-square feet of space in the Brotman Research Building at 850 Republican Street (UW Medicine).

3.5.2 A component of the VIL is the MR image analysis Core Laboratory which has been utilized in a large number of multicenter MRI studies and industry sponsored randomized clinical trials. The Core Laboratory will be responsible for overseeing transfer and receipt of imaging and clinical data, from both BMIC, linked with VIL though a secure high-speed internet connection allowing for secured transfer of images to the Core Laboratory and from the University of Utah site. The Core Lab will also be responsible for the preparation and uploading of images from BMIC and University of Utah into the Vascular Trial System (VTS), as well as maintenance and back up of the Core Lab database.

3.5.3 The VIL shall operate within a subnet of the firewall protected University network. Within the VIL, there are two central rack servers (running Windows Server) and numerous Windows based workstations. The server has 12TB of expandable storage, which is protected from hardware failures by using RAID 6 and is backed up daily. Full backups are moved offsite each month. All PCs used for image review are outfitted with EIZO medical-grade flat panel displays. Seven workstations are equipped with 16 Nvidia TITAN Xp/V or RTX 4090 GPUs for imaging sequence and artificial intelligence algorithms developments.

3.5.4 The computer hardware and custom software at the VIL shall be constructed to facilitate the imaging studies, trials, and reviews required for the study requested. Image review shall be conducted by researchers who have undergone training for intra- and extracranial vascular MR image review using specialized image review software tools (iCafe, CASCADE and MOCHA) for vessel morphology and wall analysis.

3.6 Technical Development Services

3.6.1 The Contractor shall provide MRI protocol development to scan patients using vessel wall MRI will be done on the 3T MRI scanner at the University of Washington (UW) Bio-Molecular Imaging Center (BMIC).

3.6.1.1 Once the MRI protocol is setup, technical support will be provided by the Contractor throughout the study to ensure that the MRI scans are done according to the set MRI protocol and to ensure that scans are of adequate quality for analysis. The Government will review the scans to confirm they were completed as required. Any scans not in compliance will be redone at no cost to the Government.

3.7 Recruitment Services

3.7.1 Patients will be recruited from the Puget Sound VA for Aim 3 scans. The Study Coordinator will work with a local study coordinator to recruit these patients.

3.7.1.1 A subset of 20 patients will be asked to get a repeat scan to assess reproducibility of measurements.

3.7.2 The study coordinator will coordinate study visits and MRI scans with the patient coordinator.

3.8 Contractor Requirements:

3.8.1 The contractor shall obtain all necessary licenses and/or permits required to perform this work.

3.8.2 He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract.

4.0 Other information

4.1 Contract Type:

This request is for an indefinite-delivery contract. All quantities are estimates only. The minimum award guarantee is $50,000.00

4.2 Period of Performance:

Four years without the need for option year renewals.

4.3 Place of Performance:

MRI scans will be conducted at the Bio-Molecular Imaging Center (BMIC), University of Washington, Seattle. Image analysis will be conducted at the Vascular Imaging Laboratory (VIL), University of Washington, Seattle.

4.4 Security Requirements:

The study coordinator is involved in subject recruitment will de-identify the data by providing a subjectID corresponding to the PHI. The PHI to subjectID link will be stored electronically behind a firewall. The remaining workflow (scanning and analysis) will be done in a de-identified manner using the subjectID.

Separately, any data transmitted to the VIL for analysis will be in a de-identified state using the subjectID.

4.5 Task Orders

4.5.1 All Work performed under this contract shall only be performed by the contractor via Government issued task orders against the base contract.

4.5.1.1 All Task Orders must contain the following

4.5.1.1.1 Contract Number

4.5.1.1.2 Period of Performance

4.5.1.1.3 Funded 2237 Purchase Order