Contracting
Office Address
Other Defense Agencies, Defense Advanced Research Projects Agency, Contracts
Management Office, 3701 North Fairfax Drive, Arlington, VA, 22203-1714, UNITED
STATES
Description
TRANSPORTABLE MAGNETIC RESONANCE IMAGING SYSTEM BAA 07-21 Addendum 1
DUE: May 15, 2007.
TECHNICAL POC: Dr. John R. Lowell, DARPA/DSO
Ph: (571) 218-4685
Email: baa07-21@darpa.mil
URL: www.darpa.mil/dso/solicitations/solicit.htm; Website Submission: http://www.sainc.com/dso0721/
DESCRIPTION
(Note: This BAA Addendum 1 is submitted as a Special Focus Area as described
in the original BAA, 07-21.)
The Defense Advanced Research Projects Agency (DARPA) is seeking innovative proposals
for the development of a transportable Magnetic Resonance Imaging (MRI) system
capable of field deployment to in-theater Combat Support Hospitals (CSHs) for
diagnosis and assessment of traumatic brain injuries (TBI) to front-line soldiers,
sailors, and airmen. Proposals are suggested for research programs that demonstrate
technology development and integration into an MRI system that weighs less than
800 pounds and has a footprint of less than 10 square feet; the system should
have a field of view 25 cm x 25 cm x 25 cm with 1.5 mm x 1.5 mm x 1.5 mm voxel
dimensions (hereafter 1.5 mm cubic voxel) that effectively produces 2D axial
images in 45 seconds (per 1.5 mm slice) or less.
It is expected that each research effort will consist of an interdisciplinary
team with the skills needed to address all of the relevant research challenges
necessary to meet the program goals. These research areas include (but are not
limited to): 1) Novel lightweight magnet designs that maximize field strength
and homogeneity while simultaneously minimizing stray fields and magnet weight;
2) High performance radio-frequency multi-element receiver designs; 3) Techniques
to reliably compensate for magnetic field inhomogeneities and/or non-linear field
gradients, including the use of tailored pulse sequences and/or magnet-specific
hardware to spatially compensate for static field coil inhomogeneities; 4) Novel
ultra-high sensitivity (and/or low-frequency) receivers that allow operation
in lower magnetic field regimes; 5) Techniques to miniaturize signal acquisition,
distribution, and processing hardware, including low-noise amplifiers and analog-to-digital
(A/D) converters, novel (including optical) data transfer techniques, and miniature
connector designs; and 6) Disciplined system engineering to enable use by untrained
personnel in harsh operating conditions, including reduced outward system complexity
without sacrificing overall reliability, techniques for site placement, self-calibration,
and software design that minimizes the number of operator actions for the most
commonly performed tasks.
BACKGROUND
Traumatic Brain Injuries (TBIs) are one of the most devastating injuries in the
battlefield, accounting for 15-25 percent of battlefield injuries since WWII
[Bellamy and Zajtchuk (1991) 'The Management of Ballistic Wounds of Soft Tissue'
in: Textbook of Military Medicine (R. Zajtuchuk, ed.), Washington, D.C.; Office
of the Surgeon General, pp 163-220]. At the same time, over 50 percent of all
moderate-severe TBIs from Desert Storm resulted in death. One of the few established
techniques for early diagnosis and assessment of TBIs is to perform screening
with a MRI system. This is especially true for mild to moderate TBI, which invariably
present as normal on CT scanners, the only tool available at the Combat Support
Hospitals (CSHs).
Early diagnosis of TBIs is critical for successful treatment, especially since
TBIs can go unnoticed for days; current standards of soldier care typically result
in extra-theater patient transfer during this period. While patients with TBIs
are able to be transported, special care must be taken to avoid placing patients
at increased risk; clear diagnosis and assessment of TBI before inter-theater
transport is therefore medically prudent. Placing an MRI in the CSH will therefore
have an immediate impact on front-line readiness, inter-theater logistics burden,
and the long-term outlook of injured soldiers, as early TBI diagnosis means significantly
higher probability that soldiers will regain normal quality of life.
Combat Surgical Hospitals do not have MRI systems; their extreme weight (greater
than 10 tons), large size (greater than 300 sq ft of floor space), and significant
infrastructure burdens (cryogen supply for superconducting magnets, concrete
shielded room devoid of metal, etc.) make them nearly impossible to field in
the demanding environment of a CSH, which can range from a converted hospital
to an office building to a tent.
Commercial MRI system development stresses the production of large external magnetic
fields using superconducting magnets to increase spin polarization within the
imaging volume. These magnets are designed to increasingly demanding field homogeneity
specifications, and with the addition of linear field gradients, allow received
signals spread over a range of frequencies to be de-correlated and reconstructed
into a spatial distribution of spin populations that form the basic elements
of the produced image. Recent research activities [c.f. Perlo, et al., Science
308, 1279 (2005); McDermott et al., PNAS 101, 7857 (2004); Mair et al., Magnetic
Resonance in Medicine 53, 745 (2005); and Bouchard, Phys. Rev. B, 74, 054103
(2006)] have pointed to a suite of technologies that collectively appear to offer
the distinct possibility of producing an MRI system significantly smaller and
lighter than current commercially available systems. In general, these research
activities have addressed either production of high quality images in significantly
reduced field regimes (at the extreme, this includes earth-field imaging using
superconducting quantum interference devices (SQUIDs) or atomic magnetometers)
or the production of images in static magnetic fields with significantly increased
inhomogeneity. When viewed alongside other technical advances made in such diverse
fields such as quantum information science, near-field RF antenna design, and
efficient signal processing, the research activities above indicate that a concerted
effort should be made to design a transportable MRI system to meet the compelling
needs of injured soldiers.
PROGRAM GOALS AND MILESTONES
The goal of this Program is to develop an MRI system that weighs less than 800
pounds and has a footprint of less than 10 square feet; the system should have
a field of view 25 cm x 25 cm x 25 cm, volumetric and planar image acquisition
capability with 1.5 mm cubic voxels, and acquisition times on the order of 45
seconds per slice.
The Transportable MRI Program will be separated into two phases. The Phase I
goal is to demonstrate the highest risk elements necessary to meet the end of
program goals. The Phase II program goals are to develop, demonstrate, and thoroughly
test an MRI system capable of meeting all of the stated performance criteria
(system weight, image volume, image resolution, image acquisition time, and structure
delineation). Note that proposed technologies and experimental design should
incorporate all relevant National Electrical Manufacturers Association (NEMA)
standards for evaluation of magnetic resonance imaging systems (and FDA regulatory
approval of medical devices).
Phase I will be a research effort of not more than 24 months.
Phase I program goals are:
1. Demonstrate the operation of a Phase I Magnetic Resonance Imaging system.
The Phase I system should have a minimum imaging volume of 15,625 cm3 (a cube
with each side 25 cm) and a maximum system weight of 2000 lbs (909 kg). Using
the Phase I system, the performer must demonstrate in a constructed phantom,
that they can achieve the end-of-program performance goals in at least one of
the three areas listed below (a, b, or c) without exceeding the minimum (maximum)
acceptable performance in the other areas:
a. Linear pixel dimension for 2D axial image (Goal: less than 1.5 mm; Maximum:
1 cm)
b. Effective 2D axial image acquisition time (Goal: less than 45 sec; Maximum:
200 sec)
c. Image structure delineation (Goal: less than 10 percent proton density difference;
Maximum: 35 percent proton density difference). Acquired images should enable
clear delineation of adjacent structures in an imaging phantom with proton density
differences analogous to structures found within neuroradiological images (white
matter, grey matter, CSF, etc)
2. Perform experiments that provide evidence that the areas left for performance
demonstration in Phase II will scale from their Phase I values to the Phase II
goals. These experiments need not be performed on the Phase I experimental apparatus,
although that is preferred, provided the same technical approaches are utilized
in any experimental apparatus utilized.
3. Produce a design of a Phase II MRI system, a work plan to develop it (experimental
plan, technical gap analysis), and show how the experiments proposed in Phase
II are poised to achieve the Phase II milestones.
Phase II is expected to be a research effort of between 24 and 36 months. The
Phase II program goals are to develop, demonstrate, and thoroughly test an MRI
system capable of meeting all of the following performance criteria:
1. System weight less than 800 pounds (364 kg)
2. Imaging volume: greater than 15,625 cm3 (25 cm cube)
3. Linear image resolution for 2D axial image: less than 1.5 mm
4. Effective 2D axial image acquisition time: less than 45 sec
5. Image structure delineation: less than 10 percent proton density difference
for adjacent structures.
To the extent possible, experiments should be conducted to demonstrate the ability
of the developed Phase I or Phase II MRI systems for non-invasive, non-structural
or functional imaging of the brain (i.e., functional MRI, or fMRI; Magnetic Resonance
Angiography, or MRA; Magnetoencephalography, or MEG; and similar techniques)
with identical or minimally-modified hardware.
Phase II deliverables must include a summary report of experimental data which
demonstrates that each of the five performance criteria have been achieved. Additionally,
consideration should be given to the completeness of the experimental plan to
enable submission of an application for device classification and Investigational
Device Exemption (IDE) with the FDA upon completion of Phase II. Please see http://www.fda.gov/cdrh/devadvice/
for information of the FDA regulatory requirements for diagnostic medical devices.
PROPOSAL SUBMISSION
We anticipate a two-stage source selection. It is STRONGLY ENCOURAGED that a
white paper be submitted according to the guidelines provided below.
White Paper and Full Proposal Deadlines
White papers will be accepted until March 21, 2007, NO LATER THAN 4:00PM ET.
All white papers will be reviewed no later than April 16, 2006 and recommendations
for full proposals will be provided at that time. Full proposals will be due
May 15, 2006, NO LATER THAN 4:00PM ET. White papers and proposals submitted by
fax will not be accepted. All full proposal submissions will be evaluated regardless
of the disposition of the white paper. Note that a full proposal may be submitted
at anytime before the close of the solicitation without having submitted a white
paper.
White Paper Submission Guidelines
White papers of ten pages or less (not counting cover sheet) will be reviewed
for the purpose of recommending the submission of full proposals. The white paper
must include the following sections:
1) A cover sheet that includes the Technical Point of Contact's information (name,
address, phone, fax, email, lead organization and business type), the title of
the proposed work, the estimated cost, and the duration (in months) of the proposed
work. (Note: cover sheet does not count towards page limit.)
2) An executive summary, including a clear statement of the uniqueness of the
idea. We are looking for ideas that will revolutionize MRI systems if the proposed
work is successfully completed.
3) A concise statement of the approach to the problem, the scientific and technical
challenges inherent in this approach, and possible solutions for overcoming potential
problems. This statement should end with a description of the proposed functional
system architecture. This statement will also serve to demonstrate an understanding
of the state-of-the-art in the field.
4) Briefly outline the research areas relevant to achieving program goals, initial
experiments to be conducted, and how progress towards these goals will be assessed.
5) Provide an initial estimate for the Phase I system weight, broken out by functional
and/or physical sub-system. Clearly state any assumptions and provide justification
for your estimate.
6) A cost estimate for resources over the proposed timeline. This cost estimate
should include both labor and materials costs.
7) A summary of expertise of the key personnel on the project relevant to the
program goals. If the team is multi-organizational, a proposed management structure
should also be included.
8) Brief list of relevant references.
Full Proposal Submission Guidelines
As described in BAA 07-21, full proposals shall consist of two volumes: Technical
and Cost. Follow the general guidelines for full proposal format and content
provided at: http://www.darpa.mil/dso/solicitations/solicit.htm.
Each technical proposal must have a clearly defined research team and management
approach. The research team must incorporate people with expertise in all appropriate
research areas listed above, and the proposal must clearly define how the team
will work together to achieve the program goals. One of the team members must
be designated the Principal Investigator. The Principal Investigator will be
responsible for coordinating the team and demonstrating the project milestones.
Proposals that address only a subset of the research areas listed above or do
not contain a clear indication of the Management Approach may not be considered
for funding.
In addition to the sections specified in the BAA announcement, the technical
volume of the research proposal must also contain the following information (limited
to a maximum of 35 pages):
1) Technical Approach, which should specifically address:
a. Proposed Phase I MRI system architecture. At a minimum, the functional system
architecture must be described; to the extent possible, physical and other descriptions
should be included. This should be accompanied by a concise statement of the
approach to the problem.
b. In the context of the proposed Phase I MRI system architecture, clearly outline
the scientific and technical challenges inherent in this approach, and possible
solutions for overcoming potential problems. These should be grouped into research
areas relevant to achieving the Phase I goals. For each research thrust, describe
initial experiments to be conducted, the expected contributions to the system
functions of each research thrust, and how progress along these research thrusts
will be assessed.
c. Given the stated Phase I Go/No-Go milestones (see item #4 below), provide
a detailed estimate for the Phase I system weight, broken out by functional and/or
physical sub-system. Clearly state any assumptions and provide justification
for your estimate.
d. Given the stated Phase I Go/No-Go milestones, describe the test plan utilized
to verify system and sub-system performance. In particular, provide a detailed
description of the object(s) to be imaged, including known part and/or serial
numbers, calibration(s) performed on the object, and how the object may be used
to verify system performance.
e. For the proposed Phase I system, describe the steps needed to initially place
the unit at a remote site in order to achieve the Phase I Go/No-Go milestones.
Include quantitative descriptions of all services (power, water, etc.) needed
for system operation.
2) Research Team: Clearly define the expertise of the individual team members
and how their expertise relates to the research areas defined in the technical
approach.
3) Management Approach: Define a single Principal Investigator who will coordinate
the team and be responsible for demonstrating the Go/No-Go project milestones
listed below.
4) Phase I milestones:
a. End of Phase I (Go/No-Go) milestones: The Go/No-Go milestones must be a set
of specific deliverables (e.g., demonstration, hardware, report) based on the
Phase I program goals outlined above, and must be clearly and explicitly stated.
b. Interim Phase I progress assessments: A list of smaller project accomplishments
that should occur to meet the Go/No-Go milestone must be listed. To the extent
possible, these should be time-ordered, and a lead researcher should be identified
as responsible for that accomplishment.
5) Phase II milestones: Explicitly state the Phase II milestones based on the
Phase II program goals outlined above. In particular, address both the set of
specific deliverables and any interim progress assessments needed.
Evaluation of Proposals
Evaluation of the proposals will be in accordance with BAA07-21. For general
administrative questions, please refer to the original FEDBIZOPPS solicitation,
BAA07-21, of February 14, 2007: http://www.darpa.mil/dso/solicitations/solicit.htm.
Web address for Proposal Submission: http://www.sainc.com/dso0721/
Address for Proposal Submission:
DARPA/DSO, ATTN: BAA07-21, Addendum 1
3701 North Fairfax Drive
Arlington, VA 22203-1714
General Information
In all correspondence, reference BAA07-21, Addendum 1.
Technical Point of Contact
John R. (Jay) Lowell, DARPA/DSO; Phone: (571)218-4685; Email: jay.lowell@darpa.mil
Point of Contact
Barbara McQuiston, Deputy Director, DSO; Phone: (703) 526-4759; Fax: (571) 218-4553;
Email: Barbara.Mcquiston@darpa.mil
Point of Contact
Barbara McQuiston, Deputy Director, DSO, Phone 703-526-4759, Fax 703-248-1916,
Email Barbara.McQuiston@darpa.mil
