MODIFICATION
A -- DEFENSE SCIENCES RESEARCH AND TECHNOLOGY
- Notice Date
- 2/14/2007
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Other Defense Agencies, Defense Advanced Research Projects Agency, Contracts Management Office, 3701 North Fairfax Drive, Arlington, VA, 22203-1714, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- BAA07-21
- Response Due
- 2/14/2008
- Archive Date
- 2/29/2008
- 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
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