6515--MRI/PET Molecular and Anatomic Imaging System

Summary: This is a Sources Sought notice and not a request for quotes. This request is solely for the purpose of conducting market research to enhance VHA s understanding of the market s offered products, services and capabilities. The Government will not pay any costs for responses submitted in response to this Sources Sought. This Sources Sought notice provides an opportunity for respondents to submit their notice of ability, and their available products and services in response to the requirement described below. Vendors are being invited to submit information relative to their potential of fulfilling the requirement below, in the form of a capability response that addresses the specific requirement identified in this Sources Sought. - The Veterans Health Administration (VHA) is seeking a vendor to provide the following products and/or services below. Please see the Statement of Work section below for the requested products/services and descriptions. This Sources Sought is to facilitate the Contracting Officer s review of the market base, for acquisition planning, size determination, and procurement strategy. The Department of Veterans Affairs, Columbia VA Medical Center, is in need of a combined 9.4 Tesla MRI/PET Molecular and Anatomic Imaging System. This acquisition of preclinical MRI/PET technology is to support traumatic brain injury (TBI) research projects on studying the long-term effects of mild TBI using preclinical models. STATEMENT OF WORK Combined 9.4 Tesla MRI/PET Molecular and Anatomic Imaging Technologies The VA Columbia Missouri health care location Harry S. Truman Memorial Veterans' Hospital is requesting the acquisition of preclinical MRI/PET technology to support traumatic brain injury (TBI) research projects. This technology acquisition will complement and expand the existing Molecular Imaging Technology currently housed within the VA Biomolecular Imaging Center (BIC). This technology must be capable of performing simultaneous hi-resolution Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) in preclinical rodent models (mouse/rat) of TBI. The requirements are specified as follows: General Requirements The MRI system will possess a desired field strength of 9.4 Tesla and be specifically designed for mice, rats and large animals molecular imaging studies, in-vivo and/or ex-vivo applications. Due to the site location for this instrument, the MRI system must be self-shielded and cryogen free. The MRI component of the combined MRI/PET system will include the necessary software to access all functions of the system including source code and pulse sequence programming. MAGNET The 9.4 Tesla magnet will have the following specifications: Cryogen free superconducting magnet - Minimum 250 mm clear bore - Minimum FOV of 150 mm x 90 mm FOV - Include Integral R.F. shield and associated cryo-cooling compressor - Magnet power supply and control unit - Stray field center to : 140cm radially x 170cm axially (from magnet center) - Magnet stability: <0.05ppm/hour (intrinsically stable) SHIELDED GRADIENT COILS The MRI system will include a shielded gradient coil set with water cooled shim coils having the following specifications: - Minimum 240 mm OD, Minimum 160 mm ID - Strength: 600 mT/m at 400V, 300A - Linearity +/- 5% over 90 mm DSV - Minimum Slew rate x/y/z: 1501/1028/1001 - Maximum Rise time s x/y/z: 400/585/600 - Appropriate Shim coils ELECTRONICS The MRI system will be equipped with the necessary electronics to include: - Minimum of two independent broadband RF transmit channels for excitation and decoupling. - Minimum of four independent broadband RF receive channels with associated applicable digital filters. - Low noise narrowband preamplifier - Minimum of 3 Gradient amplifiers - Shim power supply capable of minimum 5 second order shims plus B0 - Minimum of 8 receive channels - Minimum of 2 Linear Pre-amplifiers - Minimum of 4 preamplifiers to support operation of phased array and surface RF coils - Minimum of 2 preamplifiers specifically optimized for MRI spectroscopy applications for any of the following nuclei: 31P, 22Na, 13C, 19F, 3He, 17O or 129Xe. RF COILS The system will come equipped with RF coils (Quadrature/Volume, Multi-element Phased Array, Multinuclear Surface, and Transmit Only) capable of meeting the following specifications: RF Coil Requirements: Quadrature/Volume Coils Volume Species I.D. (mm) Minimum Length (mm) Minimum Type Whole Body Mouse 38mm 70mm Transmit/Receive Head Mouse 20mm 18mm Transmit/Receive 3 Mouse Mouse 65mm 70mm Transmit/Receive Whole Body Rat 72mm 70mm Transmit/Receive Head Rat 42mm 28mm Transmit/Receive Whole Body Large Animal 120mm 130mm Transmit/Receive RF Coil Requirements: Multi-element Phased Array Coils Head Mouse Surface (Minimum 2X2 Element) Receive Only Actively Detuned Cardiac Mouse Surface (Minimum 2X2 Element) Receive Only Actively Detuned Head Rat Surface (Minimum 2X2 Elements) Receive Only Actively Detuned RF Coil Requirements: Multinuclear Surface Coils Multinuclear 31P, 22Na, etc. 20mm - 31P or 22Na or 13C or 19F or 3He or 17O or 129Xe Nuclei selection at time of shipment Receive Only Actively Detuned RF Coil Requirements: Transmit Only Coils 1H Mouse/Rat 1H Nuclei Transmit Only Actively Detuned Multinuclear Mouse/Rat 31P or 22Na or 13C or 19F or 3He or 17O or 129Xe Transmit Only Actively Detuned RF Coil Requirements: Arterial Spin Labelling Coil 1H Mouse/Rat 1H Nuclei Butterfly Coil Transmit/Receive Actively Detuned The system will include appropriate spacer/centering tube to support the above listed RF coils when/if necessary. Positron Emission Tomography (PET) Module The system will include the necessary MRI fully compatible hardware and appropriate software permitting the simultaneous acquisition of PET and 9.4T MRI data with a capacity for whole body imaging of mice and rats. Detailed required specifications for the PET Module and associated hardware/software are: Minimum Transaxial Field of View (FOV): 80mm Minimum Axial FOV: 150mm System capable of operating with extended FOV using motorized bed. Minimum Spatial Resolution: 0.7mm using 3D OSEM or equivalent PET Module incorporates solid state technology PMT s to achieve optimum temperature stability. PET Module is fully removable allowing use of MRI maximum bore size for imaging. PET Module has capability to operate as a stand-alone PET when not inserted in MRI. PET Module data acquisition software supports cardiac and respiratory gating data capture PET Module data acquisition software supports acquisition of dynamic PET data in list mode for the generation of time/activity profiles and kinetic modelling. Computing software/hardware to acquire raw PET data, reconstruct PET images, and display reconstructed data both as static images and gated Cine representations is provided. The computing hardware/software provided supports simultaneous PET/MRI acquisition and stand-alone PET data acquisition. A duplicate stand-alone PET reconstruction workstation as a back-up system and off-line user system is required. This system will be equipped with identical software as installed on the combined PET/MRI workstation. The supplied instrument workstations will be equipped with the necessary Windows based operating systems including sufficient RAM (>/= 64 GB) and hard drive capacities (Minimum 2TB), including a minimum of 512GB NVMe, to support robust data acquisition, processing, and transfer capabilities for large data sets. The supplied instrument workstations will be equipped with Intel® UHD Graphics 630 processors or equivalent. Quality Control Phantoms The vendor shall include necessary quality control phantoms to permit: the ongoing assessment and verification of system image resolution and image uniformity using appropriate Jaszczak Phantoms (0.7-1.5mm rod diameter) and Uniformity Phantoms (30-60mm Diameter). the ongoing assessment and quality control of recovery coefficient, noise assessment determined as the background coefficient of variation, and image quality/lesion detectability employing an appropriate small animal NEMA IQ Phantom. Motorized Animal Pallets and Individual Animal Beds The system will include a Motorized Table for horizontal movement of animals into and out of the PET/MR system. The Motorized Table will be compatible with simultaneous or sequential multimodality imaging and be capable of supporting the required bed configurations: -Mouse Bed for brain imaging compatible with mouse head coils and whole body coils including accommodations for anesthetic gas supply, warm air circulation, physiological monitoring, and cardiac/respiratory gating. -Mouse Bed for whole body imaging (REQUIRE 2) compatible with mouse whole body coils including accommodations for anesthetic gas supply, warm air circulation, physiological monitoring, and cardiac/respiratory gating. -Multiple Mouse Bed capable of imaging up to 3 mice simultaneously including accommodations for supply of 3 separate anesthetic gas supply lines for the concurrent immobilization of 3 mice. -Rat Bed for Brain Imaging (Require 2) with an appropriate adaptation for the animal head and designed for head coils. These beds will accommodate anesthetic gas supply, warm air circulation, physiological monitoring, and cardiac/respiratory gating. -Rat Bed for Whole Body Imaging: (Require 2) designed for use with the compatible whole body RF coils. These beds will accommodate anesthetic gas supply, warm air circulation, physiological monitoring, and cardiac/respiratory gating. -Large Animal Imaging Bed for Large-Bore MR. This bed will be capable of supporting a maximum weight 2.5 kg. This bed will accommodate anesthetic gas supply, warm air circulation, physiological monitoring, and cardiac/respiratory gating. Physiological Monitoring/Body Temperature Control/Anesthesia The system will include hardware and software to provide the following capabilities: MRI compatible Cardiac and Respiratory Gating/Monitoring for physiological monitoring and gating (cardiac/respiratory) for anesthetized mice, rats and larger animals. An independent external Power Supply to support the operation of the Cardiac and Respiratory Gating/Monitoring system. A system to provide body temperature control and support for up to 3 animals simultaneously that is compatible with all system animal beds. A portable O2/Air veterinary anesthesia system (on a cart) for animals <3kg incorporating a minimum of 1 dedicated induction device, 3 dedicated outlets for very low consumption masks, and 1 outlet dedicated to a multi-mask for induction of multiple animals at 1 time. The veterinary anesthesia unit will include an Isoflurane vaporizer and be equipped with a waste anesthetic gas extraction system. Additional Post-Processing Workstation The vendor is requested to furnish a stand alone compatible post-processing workstation with the following minimum specifications: Windows 10 Pro Intel® Core i7 (8 cores) 16 GB DDR4-2666 MHz RAM (1 x 16 GB) 512 GB PCIe® NVMe M.2 SSD 2TB HD Intel® UHD Graphics 630 2TB HD 4port ethernet 1x 1GB ethernet Software Packages System operating software including user s manual and pulse programming manual to permit access to all functions of the system for experienced users. The software should allow experienced users to write pulse sequences and includes all necessary sequence library source code. The vendor is requested to provide a minimum of up to 3 remote training sessions included. The system should also support a user-friendly non-expert interface allowing users to run defined MRI/PET scanning protocols. The user interface must allow the queued execution of study acquisitions with subsequent data reconstruction and display. Vendor supplied MRI software must include software for the performance of the following: - Diffusion Imaging - Angiography - Cardiac Imaging - fMRI - Dynamic Contrast Enhancement - Short Echo Time - Relaxation - Spectroscopy VivoQuant Viewing and Analysis Software or equivalent to support the viewing and analysis of both static and dynamic image data sets across multiple modalities (CT, PET, SPECT, MR, and Optical) supporting DiCOM and non-DiCOM data structures. The software will allow a trained user to be capable of performing the following: -multi-modal registration (automated, manual and/or through the use of imaging fiducial markers) with reorientation tools -3D ROI segmentation via automatic, semi-automatic and manual tools with undo-redo capabilities -Dosimetry tools to generate 3D ROI derived input value to plug onto OLINDA EXM - an MR analysis toolkit for generating T1, T2 and ADC maps Image viewing features including slice view, multiple planar reconstruction (MPR), and tile view for dynamic MR data Plotting tools for time-activity and time-signal curves, contours and histograms Image and movie generation for all viewing functions; broad range of file formats Magnification tools to generate high-definition rendering for publication, presentation, posters. Supports for brain atlas packages (mouse, rat, select NHP) for PET, SPECT, CT and MR (multi-modal) data sets with selected PK modelling support DSI Studio or equivalent - Tractography software tools (DSI Studio or equivalent) software for mapping brain connections and correlates findings with neuropsychological disorders. The package should permit the collective implementation of several diffusion MRI methods, including diffusion tensor imaging (DTI), generalized q-sampling imaging (GQI), q-space diffeomorphic reconstruction (QSDR), diffusion MRI connectometry, and generalized deterministic fiber tracking. SpectroScan Software or equivalent - MR spectroscopy software for the performance of multinuclear in vivo spectroscopy analysis involving 31P or 22Na or 13C or 19F or 3He or 17O or 129Xe. Software should include all supporting documentation and user s guide. Basic Set of MRI Compatible Tools The vendor is requested to provide a basic set of MRI compatible tools including appropriate Hex nut drivers, Phillips screwdrivers, and Hex Allen keys that are fully compatible for use in a 9.4 Tesla field strength. On-site Applications Training The vendor is requested to provide a minimum of 4 days onsite training for staff in the operations of the MRI/PET system. The training will cover the following topics: Detailed MRI/PET system operation Use of isotopes for PET molecular imaging Animal set-up Post-processing software Data analysis and display Applications capabilities Remote Training The vendor will provide a minimum of 12 hours of remote training for PET/MR to be arranged at the VA s convenience. The vendor will provide a minimum of 3 remote sessions comprising at least 3 hrs each for the purpose assistance with MRI pulse sequence programming. Warranty/Service The vendor is requested to provide the necessary combination of warranty and preventative maintenance/service to support at least 5 full years of instrument operation. Installation Acceptance Testing The following Acceptance Tests will be carried out by the vendor upon installation and the results compared to vendor previously establish specifications: Field Homogeneity Field Stability NMR Frequency System SNR Coil SNR Coil Attenuation Coil Image Quality Gradient strength evaluating appropriateness of MR signal for multimodality co-registration Gradient linearity B0 drift (Passive Shims) Bo homogeneity Noise Level with preamp Noise level with coil All RF Coils supplied Evaluate SNR Flood maps verifying operation of all PET detectors PET Energy resolution using 22Na or 18F (Radioactive sources to be provided by Truman VA Hospital) Assess PET normalization Assess PET image quality using NEMA IQ phantom Assess maximum image resolution using Jaszczk phantom with 18F Assess Image quality & scatter fraction using NECR phantom Assess overall system sensitivity Confirm ability for precise image co-registration utilizing 2 different modalities (PET and MRI) and vendor supplied image acquisition/processing/analysis software Confirm system capability for performance of accurate attenuation correction. Demonstrate operational capability of respiratory and cardiac gating hardware for the acquisition of a combined PET/MRI data set using a live animal (Animal will be supplied by Truman VA). This will be performed using an appropriate RF coil and 18F-FDG for myocardiac imaging. 18F-FDG will be provided by the Truman VA Hospital. Demonstrate ability to acquire, reconstruct, and display dynamic PET data from animal subjects (F-18-FDG and animal will be supplied by Truman VA) OPERATIONAL UP-TIME (a) Unit must be operable and available for use 95% of the normal operational time. Operational time is considered 8:00 a.m. 5:00 p.m. (Monday through Friday). Repairs are to be made during normal work hours. Downtime will be computed from notification during normal work hours. Scheduled maintenance will be excluded from downtime. (Normal work hours are 8:00 a.m. 5:00 p.m., Monday through Friday, excluding national holidays.) Failure to meet this requirement for three consecutive months will be grounds for termination for cause under paragraph (m) of clause 52.212-4, Contract Terms and Conditions Commercial Items . (b) Refusal of access to the equipment indicates that the unit is up and running and time will not be considered when determining downtime. Refusal of access to the equipment voids the service request. SERVICE (a) Technical service training and service tools (as applicable) will be provided by the vendor to the Truman VA Biomedical Engineering Service at the completion of installation. (b) Service required by VAAR 852.210-71 or the contractor s commercial warranty shall be provided within 24 hours of notice from a VA representative. A routine service request will be issued upon any failure which degrades system performance. (b) Emergency service by a qualified engineer must be provided within 24 hours of notification. (c) Prior to and during the guarantee period, service at other than normal working hours (8:00 a.m. 5:00 p.m., excluding weekends and holidays), if at the request of the hospital, will be charged at an hourly rate which is the difference between current regular rate and premium rate. Otherwise, all services will be performed at no charge to the Government during this period. AVAILABILITY OF SERVICE AND PLACEMENT PARTS The contractor guarantees availability of servicing and replacement parts for a period of ten (10) years. SERVICE BULLETINS Two (2) copies of each service bulletin affecting safety or maintenance of equipment furnished under this contract will be forwarded to the receiving activity for a period of ten (10) years after the date of delivery. SERVICE DATA MANUAL The contractor shall supply two (2) operation and service (maintenance) manuals in hardcopy or electronic format with each piece of equipment. The manual(s) shall be the same as the manual(s) provided the manufacturer s designated field service representative(s). RESPONSES TO THIS NOTICE: - I. Response: - A. Capability statement and with general understanding of the industry and current knowledge of the product. Provide business status, SAMs UEI number or Dun and Bradstreet number, along with any subcontractors. - B. Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility in participating in a future acquisition does not depend upon a response to this notice. - II. Timeline: - A. This request will close on stated date within the Government Point of Entry (GPE). - Notes: - This Sources Sought is for planning purposes only to gain knowledge of potential qualified sources and their size classification (large business, small business, 8(a), SDVOSB, VOSB, etc.), relative to NAICS code 621512. Responses to this source sought will be used by the Government to make appropriate acquisition decisions. This notice is not a request for competitive quotes; however, any responsible source who believes it is capable of meeting the requirement, may submit a capability statement to the contracting office no later than Thursday, July 28, 2022, 3 PM EST. Interest/capability statements may be sent by email to Ann Marie Stewart, at contact@example.gov. No telephone or mailed responses will be accepted.