20-003960 - Attachment 1 DRAFT 7T Human MRI System Product Description.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

PURCHASE DESCRIPTION

New 7T MRI for FMRIF/NIMH

1. Statement of Need and Purpose:

To continue the cutting-edge research performed by the NIH, the functional MRI Facility (FMRIF) must provide researchers with access to the latest equipment, tools, and techniques for their experiments. To remain at the forefront of research, it is necessary that the FMRIF have the most modern equipment available to provide researchers with access to the latest equipment, tools, and techniques for their experiments. Specifically the NIMH requires this new 7T MRI for ultra-high-resolution MRI and fMRI studies that will further our understanding of how local neural circuits and brain connectivity function in health and how these circuits are affected by disease.

2. Background Information and Objective:

The National Institute of Mental Health FMRIF is a core resource of the National Institutes of Health (NIH) intramural research program. The FMRIF was created by the NIMH and the NINDS in 1999. Its function is to serve as a resource by which all NIH institutes can perform Magnetic Resonance Imaging (MRI) studies that further the understanding of healthy and diseased brain anatomy, function and physiology.

The specific objective of this purchase is the purchase of a new-generation high-field (7 Telsa) MRI System. The acquisition will allow the FMRIF to be able to provide the latest tools and techniques to NIH researchers, The upgraded system is to be used for clinical and preclinical human MRI research.

3. Generic Name of Product:

7T Human MRI System

4. Purchase Description:

Essential features of a new 7T Human MRI include:

• A 7T actively shielded magnet with whole body gradients – gradient strength more than

70mT/m and minimum 200T/m/s slew rate.

• At least 64 receive channels for proton.

• FDA 510(K) clearance for scanning with an included multi-channel head coil at 7T.

• A suitable radio frequency power amplifier and capability for multinuclear spectroscopy and 3rd order shims

• A high-end host computer console and separate computer dedicated to image reconstruction and dedicated neuro applications,

• A research mode which includes a facility for parallel transmission with a minimum of 8-channels for transmit and a head coil o 8-channel RF transmit array and . 8Tx/32Rx Head Coil*

5. Salient characteristics

The FMRIF/NIMH requires a 7T MRI and spectroscopy system suitable for human studies with the following components: a 7T superconducting magnet, active shim and gradient systems, radio frequency electronics and an operator console. FDA 510(k) clearance for clinical scanning is required, It is important that the 0.5 mT contour of the magnet fringe field shall be contained within a 9m x 4.5m size room. The magnet shall be delivered to the site via a shop-window and exterior wall of approximately 3mx4m. Architectural and mechanical drawings of the current space are available.

The needed characteristics for each component are given below. However, the vendor is encouraged to offer a system with the best possible specifications, and the proposed enhancements will be considered and evaluated during the technical review of the quotations.

1) Magnet

a) Superconducting and actively shielded magnet with a field strength of 7.0 T (Tesla) with an inner diameter bore of at least 80 cm.

b) Field homogeneity (fully shimmed with superconducting and/or passive shims) less than 5 ppm peak-to-peak over a 45 cm diameter spherical volume (DSV) and a water spectral line-width of less than 0.1 ppm full width half height (FWHH) over a 25 cm DSV.

c) Drift of the main field less than 0.05 ppm/hour and 0.005 ppm/hour without/with field drift compensation, respectively.

d) The magnet will employ zero boil-off technology.

e) The system will include a switch to shut-off the main field quickly and safely in case of an emergency. The location of the switch is to be determined during system installation.

f) Ramp time: The time required to ramp the magnet up and down to and from field following installation or service procedures will be specified by the vendor. A faster ramp time is preferred.

2) Room temperature shim and gradient coils

a) The room temperature active shim coil set should consist of at least 12 channels (x, y, z, 5 second order, and 4 third order terms) and a power supply. The second order channels (z2, xz, yz, x2-y2 and xy), at full duty cycle, should be able to generate field of at least 20 Hz/cm2 at the isocenter of the magnet. The third order shim set should consist of z3, z2x, z2y and z(x2- y2) channels. All room temperature active shims will be under computer control within the software environment used to run the rest of the console.

b) The patient accessible, inner diameter of the gradient on all axes coil should be at least 60 cm.

c) The gradient amplifiers will be capable of generating at least 70mT/m magnetic field gradient along each axis with a slew rate of at least 200 T/m/s.

d) Field deviation due to gradient non-linearity should be less than 8% at any location over a 300 mm diameter sphere.

e) Duty cycle at 100% power (all axes enabled) shall be at least 30%.

f) An eddy current compensation unit under computer control with at least B0, x, y, z will be supplied. After eddy current calibration by the vendor, the residual amplitude of eddy currents terms at 1 ms after the gradients are switched-off will be within 0.1%.

g) The gradient waveform control unit should operate with at least 10 microsec time resolution, 16 bit amplitude resolution and 128k word memory.

h) The gradient field stability will be better than 0.5% at maximum gradient strength on each axis.

i) The equivalent A-weighted sound level (LAeq) within the empty bore (at iso-center) of the 7T magnet and at bore entry shall be less than 110 dBA when using a 2 mm resolution (isotropic), minimum echo-spacing, single-shot EPI pulse sequence without acceleration with read gradient applied in any principal direction.

j) The system will be equipped with a hardware/software mechanism to protect the gradients and gradient amplifiers from overheating.

3) RF Electronics

a) Transmitter system

i) The transmitter system will be capable of operating either as a single channel or as a parallel transmitter array, with a minimum of eight RF transmit channels. Each channel will have fully independent modulation of amplitude and phase capable of operating at frequencies suitable for protons.

ii) RF transmit amplifiers should supply at least 8 kW pulsed, linear, power at 298 MHz when operated in the single channel mode. In the parallel transmit mode, each transmit channel amplifier should be capable of delivering at least 1 kW.

iii) The RF transmitter should contain at least one broadband channel covering the frequency range of 10-298 MHz for non-proton imaging and spectroscopy studies.

iv) The broadband power amplifier shall be capable of delivering at least 8 kW.

v) The 1H transmit system will provide 1H decoupling during 31P and 13C spectroscopy studies.

vi) All RF channels will be driven by independent waveform generators with adequate waveform memory and capable of amplitude and phase modulation. Frequency and phase control should be at least within 0.1 Hz and 0.05 degrees, respectively. A minimum of eight separate pulse shapes will be available within one pulse sequence. There shall be at least 40 dB amplitude gain and RF pulse timing resolution should be at least 2 microseconds.

vii) RF transmit power monitoring will be provided on all individual channels with an automatic mechanism to ensure that the estimated local and average SAR remains below the FDA/IEC guidelines. There will also be a system to limit the RF power to individual transmit elements.

b) Receiver system

i) The receiver system will include a minimum of 64 digital receivers capable of receiving MRI signal at 298 MHz in parallel. At least eight (8) of the receiver channels should be broadband (10-298 MHz) and able to detect MRI signals of nuclei such as 1H, 19F, 31P, 13C, and 23Na.

ii) Receivers will have a minimum of 500 kHz bandwidth with 16 bit dynamic range.

iii) The noise figure of the receiver preamplifiers should be less than 0.5 dB. The total system noise figure shall be less than 1.5 dB for each receiver channel.

iv) The system will include software that enables all receivers to be used within the full range of imaging sequences .

c) RF coils and T/R switches

i) The system will be delivered with a minimum of 3 RF coils suitable for MRI of the human head:

o Single channel volume transmit and (minimum) 32 channel receive array

(1Tx/32Rx) o Eight channel transmit array and (minimum) 32 channel receive array

(8Tx/32Rx) o Single channel surface, receiver coil (5 cm diameter)

ii) Transmit-receive switches that will operate at 31P, 13C, and 23Na frequencies shall be provided.

iii) The vendor will provide specifications and tools to allow the use of customer developed RF coils.

d) External gating and Monitoring

i) A subsystem for gated acquisition of data with a minimum of two (2) independent external signals will be included, with a minimum of 4 BNC TTL output lines.

ii) The system will provide digital recording and real-time display of respiratory and cardiac signals.

4) Console

a) The vendor will supply a state-of-the-art host computer with current scanner operation and image viewing software. The system will be equipped with software for acquisition and processing of advanced neuro-MRI and spectroscopy (1H and other nuclei) applications. The system will be equipped with automatic shimming software to optimize all active shims for each subject.

b) The system will be capable of acquiring and reconstructing in real-time at least 32 channel data with accelerated (R4) gradient-echo echo planar imaging (GE-EPI) for 30 min at 128x96 resolution and maximum slices per TR.

c) At least 1TB of disk storage for reconstructed images and at least 1TB for raw data storage will be provided.

d) A 10 Gb ethernet for general network communications with external computers is preferred. The network ports needed are available.

e) The vendor will supply the source code of purchased pulse sequences and off-line software tools to enable local development of pulse sequences and image reconstruction techniques.

5) Scanner table

a) A scanner table with accurate landmarking will be provided for precise positioning of subjects at the isocenter of the magnet that must be compatible with supplied gradients and designed to minimize vibrations.

b) The scanner table will be able to operate at low and high speed modes. The low speed mode should be suitable for human studies.

6) Warranties

The vendor shall:

a) Provide warranty for all parts and labor to repair any defects or failure in supplied items for one year from the date of Government acceptance of the system.

b) Guarantee to upgrade at no additional cost any components that are made by the vendor and become available within the one-year warranty period.

c) Supply any software upgrades free of charge within the one-year warranty period.

7) Delivery, Installation and Training:

The vendor shall deliver and install the complete system on-site (including all connections to quench ducts, vacuum pumps, cryogens for magnet ramp up etc.) and ensure that the initial performance of all equipment satisfies the required specifications within 18 months following contract award.

The vendor will provide a minimum, ten days of applications training in which staff of the FMRIF are trained in the operation of the new 7T system. Such training is to include patient handling and basic upkeep tasks, as well as operation of the system for acquisition of images and spectra. Training must also cover functions for data viewing and any online analysis features provided on the scanner.

8) Acceptance and evaluation:

a) The vendor shall demonstrate minimum specifications for all of the items listed including magnetic field drift and homogeneity, gradient performance, multiple receiver acquisition, image reconstruction, RF coils, RF power delivery and monitoring are met or exceeded.

b) Acquire T2 *-weighted spoiled gradient-echo (SPGR) imaging with multiple echoes, at high spatial resolution suitable for applications such as quantitative susceptibility mapping in brain.

c) Acquire whole-brain echo-planar imaging (EPI) suitable for neuro-functional MRI applications, at high spatial and temporal resolution (1mm, TR=800ms) with real-time reconstruction for acquisition times of 20 minutes. Capabilities of the system for simultaneous multi-slice EPI should be demonstrated.

d) Demonstrate EPI with reduced field-of-view through multi-dimensional selective excitation, suitable for neuro-functional MRI at higher spatial resolution.

e) Demonstrate that the final field homogeneity using the superconducting/passive and active shims meets the following specifications when using a spherical oil phantom:

i) Less than 25 Hz FWHH, < 75 Hz at 10% height, and < 250 Hz at 1% height over a

35 cm DSV.

ii) Less than 10 Hz FWHH, < 30 Hz at 10% height, <100 Hz at 1% height over a 25 cm

DSV.

iii) Less than 2 Hz FWHH, < 6 Hz at 10% height, < 20 Hz at 1% height over a 3 cm

DSV.

f) Demonstrate the ability, using a graphical user interface, to prescribe the geometry and location of targeted area of interest, the imaging experiments listed below in principal and oblique scan planes with minimal field of view allowed by the maximum gradient strength and receiver bandwidth. In all cases, the ghosting artifacts shall be less than 1% of average image intensity. There shall be no evidence of RF noise in the images.

g) Multiple-slice, multiple-echo image sets of up to at least 1024 x 1024. Capability for T1 weighting with inversion recovery. Capability of fat suppression.

h) Multiple slice gradient echo images of at least 1024 x 1024 with a TE of 2 ms and a TR of 5 ms.

i) Demonstrate the ability to perform sequences such as magnetization prepared rapid acquisition gradient-echo, fluid attenuated inversion recovery, fast spin-echo and MR angiography.

j) Gradient-echo (GE) and spin-echo (SE) echo-planar imaging (EPI). The pixel-wise temporal standard deviation (tSD) of the image signal (GE-EPI, 32 channel coil, 2.5 mm isotropic resolution, TR 2 s, minimum-full TE, unaccelerated, 150 volumes, oil phantom) without detrending shall be less than 3 times the tSD of a noise region without signal.

The tSD of the mean signal within an ROI (400 pixels, at the center of the slice at iso-center) shall be less than 0.3% of the mean signal. The amplitude of the EPI image ghosts shall be less than 3% of the mean signal intensity.

k) Demonstrate acquisition and real time reconstruction of (minimum) 32 channel data with accelerated (R4) gradient-echo echo planar imaging (GE-EPI) for 30 min at 128x96 resolution and maximum slices per TR.

l) Demonstrate acquisition and reconstruction of multi-band (simultaneous multi-slice) EPI using a (minimum) 32-channel receiver array. Demonstrate that image reconstruction can keep pace with an 8x multiband, 2mm isotropic EPI acquisition with maximum number of slices per TR for a continuous total scan period of at least 20 minutes.

m) Demonstrate diffusion-weighted MRI with SE-EPI on an oil phantom with following parameters: 2 mm isotropic resolution, 80 slices, b-value =3000 s/mm2, greater than 60 diffusion directions, TE= 100 ms (full k-space), TR=11 s, and in-plane acceleration factor =2. The amplitude of the EPI image ghosts shall be less than 3% of the mean signal intensity without diffusion weighting.

n) Demonstrate chemical shift imaging with 1H and 31P on concentrated test phantoms.

o) Demonstrate the ability to perform with a graphical user interface localized spectroscopy experiments (e.g. STEAM and PRESS) with 1H and 31P. Suppression of signals outside the selected voxel shall be greater than 95%.

6. Quantity

1 x MRI system

7. Delivery Date

The vendor will prepare the site, deliver and install the complete system on-site (including all connections to quench ducts, vacuum pumps, cryogens for magnet ramp up etc.) and ensure that the initial performance of all equipment satisfies the required specifications within 18 months following contract award.

8. Period of Performance:

No later than 18 months following contract award.

9. Options(s)

a. Magnet warranty: The vendor should provide options for warranty extension for an additional three (3) years after the initial year of warranty for both the magnet and the cryo-refrigeration system. The vendor should also provide options for extended service extension for an additional three (3) years after the initial warranty expires.

a. MR750 Trade-in: The FMRIF/NIMH currently owns a 3T MRI system (GE Discovery MR750) including magnet in room 10/B1D708c) which will be replaced by the 7T system requested in Product Description. The vendor will be invited to include trade-in value for this existing 3T system as a part of its proposal.

b. Turn-key install: Turn-key installation of the system which includes all site preparation and modification as well as work required to meet NIH design requirements and review.

Inspection and architectural drawings of the site can be made available to assist in preparation of the quotation.

c. On-site scientific support: The vendor is encouraged to provide an option for providing up to three (3) years of onsite scientific support, with the goal of providing dedicated design consultation and pulse-programming customization for ultra-high-field research and advanced brain imaging.

d. Head gradient insert: Vendors are encouraged to consider offering options for a high-performance gradient coil inserts that, with higher slew rates and gradient strength than a body gradient, would provide much higher spatial resolution within a limited field-of-view. Any option that would make development or installation of a gradient insert (eg providing a switch to allow easy transfer of gradient power to an insert) or that could provide very high-order shimming (VHOS) over the human is of interest.

e. Spine array coil: In addition to the requirements for head RF coils, vendors may propose one or more optional array coils designed for imaging of the human spinal cord

(cervical and lumbar) with high signal-to-noise ratio

f. MNO Coils: The vendor may offer as options multinuclear coils (e.g. 23Na and 31P)