SOLICITATION NOTICE
B -- Quantitative analysis of longitudinal magnetic resonance imaging (MRI) images
- Notice Date
- 6/29/2016
- Notice Type
- Presolicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Station Support/Simplified Acquisitions, 31 Center Drive, Room 1B59, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIDA-SSSA-NOI-2016-221
- Archive Date
- 8/13/2016
- Point of Contact
- Brian Lind, Phone: 301.827.5298
- E-Mail Address
-
lindbj@nida.nih.gov
(lindbj@nida.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The National Institute on Drug Abuse (NIDA), Station Support Contracts and Simplified Acquisitions Branch (SS/SA) on behalf of the National Institute on Aging (NIA) intends to negotiate and award a Contract without providing for full and open competition (Including brand-name) to the University of Pennsylvania, for "Early Markers of Alzheimer's Disease (AD) in BLSA Participants - Structural and Functional Brain Changes: Quantitative Analysis of Longitudinal MR Images". NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 541690, Other Scientific and Technical Consulting Services, with a Size Standard of $15 Million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-87-4-616 dated 05/09/2016. This acquisition is conducted under the procedures as prescribed in FAR subpart 15-contracting by Negotiations at an amount exceeding the simplified acquisition threshold ($150,000). STATUTORY AUTHORITY This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302-1(b)(1)(i) Unique supplies or services available from only one source or only one supplier with unique capabilities. 41 U.S.C. 3304(a)(1).   DESCRIPTION OF REQUIREMENT 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 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 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. 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 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? Period of Performance Base year: September 29, 2016 - September 28, 2017 Optional Renewal Years: Option year 1: September 29, 2017 - September 28, 2018 PROJECT DESCRIPTION: Scope of Work: The Contractor shall 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. 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.) Work to be performed: Independently, and not as an agent of the Government, the Contractor shall provide all the necessary personnel, facilities, supplies, and services (to perform the work required by this contract as set forth in this section). 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 - to provide information on regional brain structure and to localize regions of interest for the quantitation of PET studies. (Analysis of PET scan data is performed in the NIA LBN.) Therefore, image analysis must include the following: differentiation and quantification of brain volumes and cerebrospinal fluid (CSF), differentiation and quantification of gray and white matter volumes, definition and quantification of cortical and subcortical regions, 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 employed3 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. This suite of software has been developed and optimized on BLSA longitudinal neuroimaging data, as Dr. Christos Davatzikos, Director, SBIA, has been a key collaborator on the analysis of BLSA neuroimaging research program since its inception in 1993. All modifications to software utilized for this procurement require the approval of the COR or her designate. 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: 1. Data All data generated as part of this contract must be forwarded to the COR in an approved format. The delivery schedules and specific items are as follows: 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. 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. 4. Reporting Requirements a. Project Plan Within two weeks of award, the Contractor shall submit two (2) copies of a 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. b. Electronic transmission of data All data generated shall be transmitted electronically every 6 months to the COR. These data shall include. i. 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. ii. Voxel-wise maps reflecting segmented gray, white and csf tissues. iii. Voxel-wise maps reflecting gray, white and csf volumes, using the RAVENS approach (regional analysis of volumes examined in normalized space).4 iv. 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. c. Annual Progress Report The Contractor shall submit two (2) copies of a 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. The report shall also include an indication of any current problems encountered that may impede progress and proposed corrective action. SECURITY REQUIREMENTS Information Security is applicable to this requirement. A. Information Type: Mission Based Information, Scientific and Tech nological Research and Innovation. B. Security Categories and Levels (SCL) i. Confidentiality - Low ii. Imtegrity - Moderate iii. Availability - Low iv. Overall - Moderate C. Position Sensitivity Designations (PSD) Level 1: Non Sensitive (requires suitability determination with an NACI D. Prospective Offeror Non-Disclosure Agreement i. Offeror will not require access to sensitive information in order to prepare an offer. ii. Systems Security Plan Required E. Contract Clauses i. It Security Plan (IT-SP) ii.Contractor - Employee Non-Disclosure Agreement(s) iii. Information and Physical Access Security iv. HHS-Controlled Facilitites and Information Seystem Security v. Standard for Encryption Language vi. Security Requirements for Federal Information Technology Resources HHSAR 352.239-72 (January 2010) vii. Additional NIH Requirements viii. Information Security Training ix. Personal Security Responsibilitites x.Loss and\or Disclosure of Personal Identifiable Information (PII) - Notification of Data Breach CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research, specifically the review of the sources sought notice published in the FedBizOpps on February 8, 2016 and closed on February 17, 2016 with no responses. As of December, 2015, more than 2960 (N=2960) neuroimaging evaluations 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. These tools include customized tools for analysis of BLSA longitudinal imaging data. In many cases, needs of the BLSA neuroimaging research program has motivated the specific development of tools unique to this study. Existing algorithms must be used to maintain consistency as a continuity of science to this project; however, must also be capable of the development of new state of the art approaches critical for investigation of imaging changes during the earliest asymptomatic preclinical phases of Alzheimer's Disease (AD). 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 the NIA's 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. Therefore, as it is imperative that continuity of science is maintained by utilizing the existing analysis of the neuroimaging evaluations and consistency through utilization of existing, identical methodologies and protocols to the newly acquired neuroimaging datasets, Dr. Christos Davatzikos at the University of Pennsylvania, is the only source who can provide these services. CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov." A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by July 29, 2016 at 9:00AM EST and must reference number HHS-NIH-NIDA-SSSA-2016-221. Responses may be submitted electronically to Brian Lind, Contracting Officer at lindbj@nida.nih.gov. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDA-2/HHS-NIH-NIDA-SSSA-NOI-2016-221/listing.html)
- Place of Performance
- Address: BRC, 251 Bayview Boulevard, Baltimore, Maryland, 21224, United States
- Zip Code: 21224
- Zip Code: 21224
- Record
- SN04167184-W 20160701/160629235936-b4393bec9546b308a6dd66c501187da4 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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