SOURCES SOUGHT
B -- Early Markers of Alzheimer’s Disease (AD) in BLSA Participants-Structural and Functional Brain Changes: Quantitative Analysis of Longitudinal Magnetic Resonance Imaging (MRI) Images
- Notice Date
- 2/8/2016
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, 6001 Executive Boulevard, Room 3155, MSC 9593, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-SBSS-2016-169
- Archive Date
- 3/3/2016
- Point of Contact
- Samantha A. Kelly, Phone: 3014028855
- E-Mail Address
-
samantha.kelly2@nih.gov
(samantha.kelly2@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT NOTICE 1.Solicitation Number:HHS-NIH-NIDA-SSSA-SBSS-2016-169 2.Title: Early Markers of Alzheimer's Disease (AD) in BLSA Participants-Structural and Functional Brain Changes: Quantitative Analysis of Longitudinal Magnetic Resonance Imaging (MRI) Images 3.NAICS Code: 541990- All Other Professional, Scientific and Technical Services 4.Description: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. This notice is issued to help determine the availability of qualified companies technically capable of meeting the Government requirement and to determine the method of acquisition. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Background: Since 1958, the Baltimore Longitudinal Study of Aging (BLSA) has been a major research program conducted by the National Institute on Aging (NIA). The BLSA is a multi- disciplinary study of physiologic and psychological aspects of normal aging in community-dwelling men and women. Active BLSA participants are volunteers who visit the Clinical Unit of the NIA-IRP in Baltimore, MD for testing every 1 to 4 years. Since 1994, we have been conducting a longitudinal brain imaging study of selected older adults in the BLSA to characterize individual differences in longitudinal brain changes, to investigate the extent to which these brain changes underlie individual differences in cognitive aging, to identify brain changes that may be predictors of cognitive decline and Alzheimer's disease, and to assess the impact of potential modulators of brain and cognitive aging. As of December, 2015, more than 2960 neuroimaging evaluations (N=2960) have been performed for BLSA participants. As part of this research program, it has also been necessary to develop and validate sophisticated tools for analysis of longitudinal neuroimaging data that can be applied in large-scale studies. Thus, this project has involved the development, validation, and refinement of novel image analysis tools and the application of these new tools to longitudinal volumetric MR imaging scans and measures of Positron Emission Tomography (PET) measures of regional cerebral blood flow and amyloid deposition in brain. More recently, these tools include advanced machine learning approaches using pattern analysis to classify clinical status of individuals based on structural and functional brain images. More than 150 publications have resulted from the work of the initial phases of this study. The work of this requirement will continue to focus on the development of sophisticated tools and quantitative analysis of longitudinal structural MRI data acquired from BLSA participants. This project will continue to provide important information for researchers and clinicians on age changes in brain structure, their associations with cognitive change, and factors that modulate these associations, including risk factors for cognitive decline and Alzheimer's disease as well as factors that promote the maintenance of cognitive health. Through the use of the existing physical and psychological data for BLSA participants collected over many years, this project will provide unique insights into our understanding of early predictors and the temporal sequence of individual differences in the rate of neuroanatomic, neurophysiologic and cognitive aging. These neuroimaging data will also provide important normative data, including the frequency and extent of brain abnormalities in community-dwelling individuals, from which to evaluate pathological aging. While a number of studies have shown that structural and functional longitudinal changes in specific temporal lobe regions predict cognitive impairment and Alzheimer's disease, BLSA studies have shown that using networks of information throughout the brain via advance methods of pattern analysis provide greater sensitivity and specificity to predict who is likely to develop cognitive impairment and dementia and who is likely to remain healthy1, 2. Thus, the proposed contract will require methods that show longitudinal consistency of measures of global and regional brain volumes and ischemic lesion volumes, including consistency with MR data acquired during earlier phases of this project (since 1994). This Contract will also require the application and continued development of sophisticated analytic approaches, including machine learning and pattern analysis methods, to allow classification of risk for cognitive impairment on an individual subject basis. Purpose and Objectives: The NIA requires the Contractor to provide sophisticated quantitative analysis of structural MR imaging data, including MR images already acquired (N = 2960) and new MRI data with approximately 300 new MR datasets collected each year of the proposed contract. The proposed contract will include more recently acquired MR images from the sample of approximately 70 active BLSA neuroimaging study participants from our original sample age 55 and older (imaging begun in 1994) and will add image analysis of more recently acquired data from the NIA 3T MRI facility, including younger BLSA participants. The addition of comparable MRI data from younger participants as part of routine BLSA visits and expansion of the MR imaging sample will allow investigation of age-related changes throughout adulthood. Overall Project Requirements: The proposed contract will require analysis of MR images provided by the Laboratory of Behavioral Neuroscience, Intramural Research Program, NIA. The Contractor shall be required to develop an imaging pipeline and perform quantitative analysis of MP-RAGE T1 weighted volumetric scans, double echo scans (3 mm proton density/T2-weighted), and 3 mm FLAIR acquisitions (sequence details below) to provide measures of intracranial volumes, whole brain, gray matter, white matter, and regional brain volumes using a multi-atlas labelling approach based on a validated approach to region definition. The Contractor shall use these imaging data in combination to provide the NIA-LBN with measures of normal and abnormal tissue volumes throughout the brain. (For context, additional imaging scans collected for these participants include Diffusion Tensor Imaging (DTI), resting state functional MR (fMR), task-related fMR, and positron emission tomography (PET) amyloid imaging in a subset of participants, but analysis of these additional scans is not part of the current acquisition.) The principal goal of this procurement is the quantitative analysis of longitudinal MRI data to provide measures of brain structure in BLSA participants. Specifically, the primary objectives are to continue to address the following questions: •What are the rates and regional distribution of changes in brain anatomy in non-demented men and women throughout adulthood? •What is the frequency and progression of brain abnormalities in older adults and what is the clinical significance of these findings for cognitive aging? •Against a background of age-related changes in brain structure, which changes predict cognitive impairment and dementia, and conversely, what are the predictors of the maintenance of cognitive health? •What factors modulate cognitive and brain aging and how do they impact brain-behavior associations? Scope of Work: Independently, and not as an agent of the Government, the Contractor shall provide all the necessary personnel, facilities, supplies and service to perform the following requirements: A.General Requirement: The Contractor shall be responsible for image processing and quantitation of 2960 brain MR scans acquired previously, the majority on the NIA 3T Philips MR scanner, as well as approximately 300 scans to be acquired on an annual basis using the same imaging protocols. The image processing must be consistent with methods used in earlier phases of the BLSA neuroimaging study to allow longitudinal consistency of data analysis. B.Specific Requirements: The purpose of acquiring structural MR images is twofold - 1. to provide information on regional brain structure and 2. to localize regions of interest for the quantitation of PET studies, where analysis of PET scan data is performed in the NIA LBN. Therefore, image analysis must include the following: 1.Differentiation and quantification of brain volumes and cerebrospinal fluid (CSF); 2.Differentiation and quantification of gray and white matter volumes; 3.Definition and quantification of cortical and subcortical regions; 4.Quantification of lesion volumes, including infarcts and periventricular hyperintensities, labeled templates of brain regions for registration and overlay on PET images for regional definition The following imaging series shall be used for analysis of normal and abnormal tissue volumes: •A 3-dimensional volumetric MPRAGE scan - (sagittal acquisition - TR: 6.8ms; TE: 3.1ms, MATRIX: 256X256, SLICES: 170; PIXEL SIZE: 1.1 X 1.1; SLICE THICKNESS = 1.0; FOV: 240) •A 3 mm double echo series - (axial acquisition - TR: 3000ms; TE: 8.0/100 ms; MATRIX: 256 x 218; SLICES: 50; PIXEL SIZE: 0.94 x 0.96; SLICE THICKNESS: 3mm; FOV: 240) •A 3 mm FLAIR series- (TR: 11000/ TI 2800; TE: 68; MATRIX: 288 X 266; SLICES: 50; PIXEL SIZE: 0.83 X 0.90; SLICE THICKNESS: 3MM; FOV: 240)   Quantitative Image Analysis: Both regional analysis and voxel-based analysis of MR image data shall be performed. Volumetric analysis of MR data shall involve removal of extracranial material, cerebellum, and brainstem inferior to the mammillary bodies, tissue classification of remaining material, stereotaxic transformation to the Talairach or other standard atlas, and regional definition. The validated approaches for all phases of the analysis employed for image processing of BLSA data shall be employed and any proposed changes to image quantification procedures must be validated against the original analytic methods to ensure the longitudinal integrity of the data. In particular, nonlinear registration of images shall be performed, the RAVENS4 approach shall be used for determination of tissue volumes and creation of gray matter, white matter, CSF and lesion maps, and the procedure detailed by Lao et al5 shall be used for lesion quantification. In addition, this procurement requires application of the current suite of software developed, validated, and maintained by the Section on Biomedical Image Analysis (SBIA), Department of Radiology, University of Pennsylvania as this suite of software has been developed and optimized on BLSA longitudinal neuroimaging data, of BLSA neuroimaging research program since its inception in 1993. A training set of MR images shall be maintained, which will be used to establish and maintain inter-operator reliability and longitudinal consistency of the processed data. Longitudinal analysis of imaging data: The BLSA neuroimaging study requires novel approaches to analysis that account for the longitudinal nature of the BLSA MR imaging data. Novel methods that maximize the consistency and accuracy of longitudinal data across scanners and over time are required. These methods may include methods for 4-dimensional image analysis, incorporating information in the temporal as well as spatial dimension, to obtain accurate estimates of very subtle longitudinal changes during normal aging and accelerated changes associated with cognitive impairment.6 Alternatively, multi-atlas labelling approaches may be used to enhance longitudinal stability and obtain more accurate estimates of rates of brain changes. Of particular importance is the modeling of abrupt changes in imaging contrast and noise introduced by scanner or protocol changes. The Contractor shall provide estimates of global and regional tissue volumes, incorporating these new approaches to enhance the ability to detect subtle longitudinal changes. Classification of images using multi-modal imaging data: The BLSA acquires multi-modality imaging data that reflect complex spatiotemporal aspects of brain anatomy in individuals who maintain cognitive health as they age and in those who develop cognitive impairment. This procurement requires the application of advanced imaging pattern analysis methods that predict an individual's risk for cognitive impairment on an individual subject basis. Examples of the approach used previously in the BLSA include the SPARE-AD2 and SPARE-CD7 indices as individualized predictive markers of AD and mild cognitive impairment, as well as of cognitive decline in cognitively normal older adults. The Contractor shall provide SPARE-AD scores for MR images analyzed in this contract. Data Security: The Contractor shall provide a data security plan to ensure the confidentiality of participant information and the integrity of all data collected under this contract. Replication, Dissemination or Use of Results: Data will be used by members of the NIA to examine the relation between changes in brain structure and function with normal aging and changes in neuropsychological performance. All data collected under this contract shall be forwarded to the NIA and a copy will be stored at the NIA. Results will be disseminated to the scientific community via presentations at scientific meetings and publications in professional journals. Collaboration of the Contractor principal and co-principal investigators with NIA Investigators in data analyses and reporting of study results will be encouraged. The Contractor is prohibited from publishing or disseminating information from work performed under this contract without prior written approval from the COR, in accordance with HHSAR 352.224-70, Confidentiality of Information. The confidentiality of information collected from BLSA participants is protected under the Privacy Act, as described in the Federal Register, Vol 53., No. 225, Tuesday, November 22, 1988, pp. 47313-4. All publications and abstracts involving BLSA data must undergo NIH clearance prior to submission. Deliverables: Data: All data generated as part of this contract must be forwarded to the Contracting Officer's Representative in an approved format. The delivery schedules and specific items are as follows: 1.Every 6 months: Quantitative results of image processing as described above, including volumetric quantification for MRI. All intermediate files for image processing, which contain regional definitions, segmented volumes, coordinates for reslicing, voxel-based RAVENS maps, smoothed maps using the latest software algorithms, etc. must also be delivered to the NIA. 2.Other requirements: During the performance and upon completion of the contract, all data collected under this contract shall be the property of the National Institutes of Health (NIH). In addition, the NIA will have the rights to use all software employed in image processing, although ownership of such software is not required. Reporting Requirements: 1. Project Plan: Within two weeks of award, the Contractor shall submit two (2) copies of a written project plan. This plan shall include the following: a current plan for image processing, and an outline of issues requiring further discussion. The Contractor shall hold a teleconference meeting with the NIA COR to review the plan and remaining issues within one week of the submission of the project plan. 2.Electronic transmission of data: All data generated shall be transmitted electronically every 6 months to the COR. These data shall include. a) An excel spreadsheet including BLSA participant and visit numbers or other identifiers, types of scans, quantitative measures of intracranial volumes, gray, white and cerebrospinal fluid volumes for the whole brain and for regions defined by a brain atlas approved by the COR. This spreadsheet shall also include normal and abnormal tissue volumes for each region, as well as the SPARE-AD scores generated for the dataset. b)Voxel-wise maps reflecting segmented gray, white and csf tissues. c)Voxel-wise maps reflecting gray, white and csf volumes, using the RAVENS approach (regional analysis of volumes examined in normalized space).4 d)Voxel-wised maps or transformation matrices indicating regional labeling of MR volumes to allow registration and definition of regions on PET images analyzed by LBN investigators. 3.Annual Progress Report: The Contractor shall submit two (2) copies of a written progress report within fifteen calendar days at the end of each year of the contract. This report shall include the following: a)A cover page containing i. Contract number and title; ii. Period of Performance being reported; iii. Contractor's name and address; iv. Author(s); and v. Date of Submission. b)The numbers of participants processed for each imaging modality, including MR. c)The report shall also include an indication of any current problems encountered that may impede progress and proposed corrective action. Anticipated period of performance: Base Period: 09/29/2016 through 09/28/2017 Optional Renewal Years: Option Year 1: 09/29/2017 through 09/28/2018 Option Year 2: 09/29/2018 through 09/28/2019 Option Year 3: 09/29/2019 through 09/28/2020 Option Year 4: 09/29/2020 through 09/28/2021 Anticipated place of performance: The principal place of performance is the contractor's business address. Capability statement /information sought. Contractors that believe they possess the ability to provide the requirement should submit documentation of their ability to meet each of the project requirements to the Contract Specialist. The response should directly and specifically state in the, capabilities statement, which project requirements you can supply. Contractors must also provide their Company Name, DUNS Number, Physical Address, Point of Contact, and Size and Type of Business (e.g., 8(a), HubZone, etc.) pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11-point or 12-point font, 8-1/2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The information submitted must be must be in and outline format that addresses each of the elements of the project requirement and in the capability statement /information sought paragraphs stated herein. A cover page and an executive summary may be included but is not required. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. All responses (capability statements) sent in response to this Small Business Sources Sought Notice must be submitted electronically (via e-mail) to the Contract Specialist. Facsimile responses are NOT accepted. The response must be submitted to Samantha Kelly, Contract Specialist at e-mail address Samantha.Kelly2@nih.gov The response must be received on or before February 17, 2016 at 8:00AM, eastern time. "Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a presolicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."
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