B. SSJ.MRI-CT Brain and body 2025.1 year.FE.pdf

SOLE-SINGLE SOURCE (including Brand-Name) JUSTIFICATION

1. Identification of the Agency and Contracting Activity.

a. Federal Agency and Contracting Activity.

Department of Health and Human Services National Institute of Health National Institute on Drug Abuse

b. Sponsoring Organization.

National Institute on Aging Laboratory of Behavioral Neuroscience

c. Project Officer Information.

Wendy Elkins, MS National Institute on Aging Laboratory of Behavioral Neuroscience Biomedical Research Center 251 Bayview Boulevard Suite 100, Room 4B317 Baltimore, MD 21224 Telephone Number: (410) 558-8610 FAX Number: (410) 558-8518 E-mail address: wendy.elkins@nih.gov

2. Nature and/or Description of the Action Being Approved.

a. Acquisition Purpose and Objectives.

The Baltimore Longitudinal Study of Aging is the longest running study of human aging in the United States. In the modern era of the study a program of testing has been implemented in order to enhance our understanding of age-associated physical and biological changes in health and disease. Study visits incorporate imaging studies of the brain and selected areas of the body using several techniques:

magnetic resonance imaging (MRI), including diffusion tensor imaging (DTI) and resting state functional MRI of the brain, and computed tomography (CT). We investigate structural and functional brain changes and how they relate to age-associated changes in cognition, and factors that modify cognitive and brain aging as well as the contribution of change in body composition to aging syndromes, chronic disease and disability. The purpose of the proposed procurement is to provide NIA investigators the following:

1. For each type of brain imaging data the contractor shall retrieve data and co-register all image data into a common coordinate system. The Contractor will coordinate with the NIA to ensure that consistent common imaging reference spaces are used across projects.

2. Apply image processing tools developed and validated under a prior contract

75N95020P00369 neuroimaging requirements:

a. Define gray matter regions of interest. Targeted regions include the Hippocampus, Posterior Cingulate, Precuneus, and Medial Frontal cortex.

b. DTI Pre-processing. The Contractor will perform and provide the

Government with pre-processed image data, yielding fractional anisotropy (FA), mean diffusivity (MD), principal eigenvector (v1), and tensor (D) images for each subject.

c. Define white matter tracts. The FA maps for each subject will be labeled with a white matter atlas (i.e., the Johns Hopkins “Eve” atlas).

d. rs-fMRI Pre-processing. Pre-processing will yield functional connectivity maps for each gray matter and white matter region of interest. The Contractor shall use the defined gray matter regions of interest on structural data for rs-fMRI analysis.

e. Region of Interest Analysis. The Contractor will generate and provide to the LBN, NIA a table of means and standard deviations of rs-fMRI, FA, and MD for all regions of interest.

f. Implement mass-univariate temporal modeling. The Contractor shall work with the LBN/NIA team and their collaborators to implement temporal association inference models (e.g., “causal”) to implement in current toolboxes.

g. Characterize temporal inference in simulation. The Contractor shall perform data-driven simulations to verify that the inference method empirically performs according to theoretical predictions and is compatible with standard approaches for multiple comparisons corrections (e.g., false discovery rate [FDR]).

h. Apply multi-modal temporal inference to BLSA 1.5T/3T cohort.

The Contractor shall work with LBN investigators to execute structural-functional-covariate analysis in the form of a general linear model (GLM, voxelwise model of the form: ) where both the regressors and the regressands may be longitudinally sampled imaging variables. The temporal relationships between sequenced regressors and regressands will be assessed. Additional non-imaging data may be provided for each subject in the form of an Excel document. These will be run as additional regressors.

i. Scanner calibration. The Contractor shall implement scanner calibration/correction, including modeling scanner changes as nuisance variables and using image preprocessing corrections.

3. Apply image processing tools for BLSA MRI of the thigh, CT of the abdomen as well as CT of the leg.

a. The Contractor shall perform segmentation and quantify regions of interest captured in the BLSA thigh MRI protocol including, but not limited to:

subcutaneous fat, inter-muscular fat, and muscle.

b. The Contractor shall perform segmentation and quantify regions of interest in images captured in the BLSA CT protocol including images of the abdomen, thigh, as well as the proximal, mid and distal tibia. Regions of interest include but are not limited to:

- Abdominal subcutaneous and visceral fat

- Thigh subcutaneous fat, inter-muscular fat, muscle, and bone

- Tibia subcutaneous fat, inter-muscular fat, muscle, and bone

c. The Contractor shall apply the image processing tools to both newly acquired images as well as the library of historical images to generate fully harmonized longitudinal thigh MRI and CT imaging data sets.

4. Support method translation to NIA intramural researchers.

a. The Contractor shall provide BLSA investigators and study staff with documentation of methods, including user manuals, and assist with installation and implementation of software as necessary. The Contractor shall document methodological contributions in the form of peer-reviewed publications.

b. Project Background.

This acquisition involves continued work begun under contracts 75N95020P00369, HHSN27101300672P and HSSN271201400118C. In the initial phase of the project, a database and image processing pipeline was established to perform customized processing of structural and functional brain images of NIA participants in the Baltimore Longitudinal Study of Aging (BLSA). The initial period of performance for this project utilized 3T MRI data acquired on the NIA 3T scanner through March 31, 2013. In addition, the contractor (Dr. Bennett Landman of Vanderbilt University) developed customized software for analysis of BLSA images and is developing customized software for investigation of structure-function associations to allow mapping of functional connections in the human brain. There is a continuing need for analysis and development of methods for statistical analysis of structure-function relationships of longitudinal NIA BLSA images. Streamlining processing, updating methods, and harmonizing historical data for the abdomen and leg are also a priority.

The BLSA collects longitudinal imaging data on an ongoing basis, with approximately 300 sets of MRI and CT data annually. In addition, tools for analysis of structure-function relationships including both temporal and spatial analysis are limited and require customization for longitudinal analysis. Such tools will continue to be developed and validated under this acquisition. Current Contract information: (i) contractor: Dr. Bennett Landman, Vanderbilt University; (ii) period of performance: September 30, 2020 – September 29, 2025.

3. Description of the Supplies or Services Required to meet the agency’s needs (including the estimated value).

a. Project Title.

Baltimore Longitudinal Study of Aging (BLSA) image processing services.

b. Project Description.

SOW attached

• Requirement Type.

Research & development (R&D) ❑ R & D support services X Support services (non-R&D) ❑ Supplies/equipment ❑ Information technology (IT) ❑ Construction ❑ Architect-engineer (A & E) services ❑ Design-build Other (specify): _Image Processing___________________

• Type of Action.

❑ New requirement Follow-on ❑ Other (specify): ______________________

• Proposed Contract/Order Type.

X Firm-fixed-price ❑ Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ ❑ Cost-plus-fixed-fee ❑ Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ ❑ Time and materials ❑ Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________

❑ Other (specify): ___________ ❑ Completion Form ❑ Term form

• Acquisition Identification Number.

c. Total Estimated Dollar Value and Performance/Delivery Period.

The contract period will be one year beginning 9/30/25-9/29/26. The total contract is for $101,896.00.

4. Identification of the Statutory Authority Permitting Other than Full and Open Competition.

This acquisition is conducted as set forth in Federal Acquisition

Regulation (FAR) 13.106-1(b)(1).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Bennett Landman, Ph.D.

Associate Professor Department of Electrical Engineering Vanderbilt University, School of Engineering Director of the Center for Computational Imaging Vanderbilt University Institute of Image Science 2301 Vanderbilt Place PO Box 351679 Station B Nashville, TN 37235-1679

Phone: 615-322-2338 Email: bennett.landman@vanderbilt.edu

DUNS number: 965717143

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Dr. Landman of Vanderbilt University has written customized statistical code for BLSA neuroimaging data. He has developed methods for two unified regression and inference approaches, model II regression and regression calibration, for use in massively univariate inference with imaging data. These methods use the design matrix paradigm and account for both random and non-random imaging regressors. Dr.

Landman and his staff are uniquely experienced with these methods and their application to BLSA data, as required for this contract. These methods, as well as other customized scripts written for BLSA data by Dr.

mailto:bennett.landman@vanderbilt.edu

Landman, will be utilized in the pre-processing and statistical analysis of the multi-modal longitudinal neuroimaging data in this contract. In addition Dr. Landman and his staff have substantial experience in segmentation and analysis of muscle and fat in both MRI and CT images. Dr. Landman is uniquely qualified to accomplish the goals of this contract and to meet the timetable for deliverables given his prior development of code required and quantitative analysis for the specified image processing and longitudinal analyses, as required for continuity of BLSA research. This acquisition involves continuing work on BLSA multi-modal longitudinal image analysis for which Dr. Landman has demonstrated excellent past performance and innovation.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

No source other than Dr. Landman’s group at Vanderbilt University can meet the requirements of this project because he will build upon customized methods and software developed by his group. Dr. Landman is able to meet the continuing requirements of the Government need and a change to another contractor would result in at least a one year delay in deliverables, with redundant cost to the Government.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

A contract will only be awarded if during negotiations if the cost is fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

No source other than Dr. Landman’s group at Vanderbilt University can meet the requirements of this project because he will build upon customized methods and software developed by his group. Dr. Landman is able to meet the continuing requirements of the Government need and a change to another contractor would result in at least a one year delay in deliverables, with redundant cost to the Government.

9. Any other facts supporting the use of other than full and open competition.

Dr. Landman has demonstrated exceptional performance during the prior contract period at a modest cost. He has developed and extended innovative and accurate software for processing longitudinal multi-modal images for investigation of structure-function relations that are critical to the mapping of human brain activity and networks. Award to a new contractor would require duplication of the prior deliverables and a substantial project delay.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

It is not expected that this Contract would continue beyond the 1-year period.

12. Program Office Certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer Wendy Elkins, Program Manager

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer