75N95020Q00053_BLSA_Imaging_Services_SOW.pdf

Version 11-30-2016-1 FAR Part 11—Describing Agency Needs

STATEMENT OF WORK (SERVICES)

(SOW)

GENERAL INFORMATION

Title of Project:

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

Statement of Need and Purpose:

The purpose of this requirement is to obtain methodological and technical expertise in the processing of functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI) as well as computed tomography (CT) images. These services will continue the established protocols and statistical approaches for the analysis of white matter correlates of alterations in functional connectivity as well as functional connectivity correlates of white matter alterations in the brain. At the same time, this requirement includes development and implementation of new image processing techniques for the evaluation of body composition and bone morphometry in the abdomen and leg. The provision of these capabilities will facilitate the continued use of BLSA data in state-of-the-art imaging studies related to cognitive and motor function.

Background Information and Objective:

Begun in 1958, the BLSA is a continuously enrolled cohort study of community dwelling adults that seeks to evaluate change in medical, physiological, cognitive and physical function across the adult life span. In the modern era of the BLSA, study visits incorporate a wide range of tests including imaging studies.

MRI evaluations of the brain have been acquired in subsets of BLSA participants since 1994 as part of the NIA Laboratory of Behavioral Neuroscience (LBN) research program on early markers of Alzheimer’s disease and cognitive decline, more generally. In addition to brain MRI, MRI images at mid-thigh have been acquired by the BLSA since 2011 to describe muscle and fat content in the leg. CT was introduced into the BLSA protocol in 2006 and captures information on bone, muscle, and fat. Evaluation of bone morphometry offers a quantitative assessment of osteoporosis, a risk factor for fracture and subsequent disability. In addition to decreases in bone density with age, it is understood that the quantity and distribution of muscle and fat change with age. These shifts in body composition are hypothesized to be key contributors to aging syndromes, chronic disease and disability. Imaging studies offer an opportunity to describe underlying tissue composition that is masked in anthropometric measurements such as body mass index or waist circumference. Rapid advances in image processing have occurred since the initiation of body composition and bone morphometry assessments in BLSA. The application of up to date methods and best practices for both newly acquired and historical images from thigh MRI and CT will offer more refined body composition information capable of addressing current research questions.

Period of Performance:

The contract period of performance will consist of a twelve (12) month base period and four

(4) twelve month option periods as follows:

Base Period: 09/30/2020-09/29/2021

Option Period 1: 09/30/2021-09/29/2022 Option Period 2: 09/30/2022-09/29/2023 Option Period 3: 09/30/2023-09/29/2024 Option Period 4: 09/30/2024-09/29/2025

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

Specific Requirements:

The Contactor shall work in collaboration with BLSA investigators and study staff of the National Institute on Aging to provide image processing services as follows:

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 shall 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

HHSN27101400118C 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 shall 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 shall 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 select the most promising 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 develop and evaluate strategies for scanner calibration/correction, including modeling scanner changes as nuisance variables and using image preprocessing corrections.

3. Develop, validate and 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 develop strategies for the segmentation and quantification of 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 develop strategies for the segmentation and quantification of 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.

LEVEL OF EFFORT:

The estimated level of effort for this requirement is four (4) contractor employees on a part time basis as follows:

Personnel Effort, hours per year

Base period

Option year 1 2 3 4

Director 100 100 100 100 100 Data analyst 800 800 800 800 800 Staff (graduate assistant) 1000 1000 1000 1000 1000 Staff (graduate assistant) 1000 1000 1000 1000 1000

GOVERNMENT RESPONSIBILITIES

The Government will provide de-identified BLSA MRI and CT imaging data to the Contractor and associated metadata necessary for analyses, such as sex, age, cognitive status, as well as health variables. All data provided to the Contractor must be treated as confidential and not be disclosed to any third party.

DELIVERY OR DELIVERABLES

The Contractor shall report at least bimonthly by email or phone contact regarding an update of their progress and any image analyses. The Contractor shall deliver at 6 month intervals and at the end of the contract pre-processed images and results of statistical analyses detailed under project description. All data shall be in the form of electronic files.

REPORTING REQUIREMENTS

Not applicable.

OTHER CONSIDERATIONS

Travel:

The contracted work involves no travel requirements.

Key Personnel:

Not applicable. The government is not specifying key personnel or personnel qualifications.

Information System Security Plan:

All data will be de-identified. Data transfer and storage will follow NIA requirements for such data.

Data Rights:

The National Institutes on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General, ” is hereby incorporated by reference and made a part of this contract/order.

Section 508—Electronic and Information Technology Standards:

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

Publications and Publicity:

The Contractor shall document methodological contributions in the form of peer-reviewed publications.

Confidentiality of Information:

Data will be deidentified