Contract Management Branch, National Institute of Neurological Disorders and Stroke, NIH, Federal Building, Room 901, 7550 Wisconsin Avenue, MSC 9190, Bethesda, Maryland 20892-9190

A -- REQUEST FOR INFORMATION FOR PEDIATRIC ANATOMIC NEUROIMAGING DATA BASE INITIATIVE SOL NINDS-98-RFI-01 DUE 052998 POC Raina Cervantes, Contracting Officer, (301) 496-1813 E-MAIL: Laurie Leonard, ll44s@nih.gov. The NINDS, NIMH, and NICHD are putting forth an initiative to establish a pediatric brain MRI data base. The information requested below will aid in planning and developing a possible solicitation for participating pediatric study centers. It is our opinion that the most suitable target audience to respond to this inquiry would be organizations engaged in pediatric neuroimaging research. Many obstacles have impeded neuroimaging research on childhood brain disorders. These include difficulties in obtaining data from children given their limited ability to comply with procedures, the lack of an adequate normative data base with which to characterize normal brain development and against which to identify and measure aberrant brain development, the lack of adequate image analysis tools for characterizing developmental brain changes in the brain, and a lack of adequate means for sharing data analytic tools. These issues were recently addressed in a workshop entitled "Tools for Pediatric Neuroimaging" jointly sponsored by NIMH, NINDS, and NICHD. Participants of this workshop included both scientists intimately involved in developing neuroimaging methods (tool developers) and clinical researchers involved in pediatric neuroimaging. From this workshop emerged the urgent need for a normative data base of anatomic MRI brain scans from children and adolescents. This data base would serve several purposes: (1) to allow or encourage study of normal brain development. (2) to provide a necessary, representative, and reliable source of normal control data for studies of children with brain disorders and diseases. (3) to provide for construction of normal brain anatomic growth curves; and (4) to aid in development of pediatric neuroimaging tools. Scientists will be able to save time and money by exploiting this data base. To aid in the design of a possible future solicitation, we ask that interested organizations submit the following information regarding your current neuroimaging data acquisition and image analysis protocols. Please describe: A. With respect to anatomic MRI: 1. Your study samples: (a) Your existing study samples, as well as samples potentially available to you, including the ages of subjects you have successfully scanned. (b) Your procedures for recruitment and enrollment of study subjects, including outreach efforts and strategies. (c) The number of subjects with what diseases/disorders you have studied. (d) Documentation of your ability to recruit normal children for neuroimaging studies within a 12-15 month time period. Specify if your recruitment capabilities would be suited to a particular age range. (e) Demographic measures: age, gender, race, and socioeconomic composition available for your control samples. (f) Your current and proposed methods for defining normality within the age span of 0 to 18 years and your procedures for recruitment and enrollment of study subjects: histories (e.g., standardized forms); examinations (e.g., physical and neurological examination measures -- clinical, standardized, quantitative); and neuropsychological measures (e.g., IQ testing, neuropsychological and behavioral test batteries). 2. Your current image acquisition and analysis tools: (a) Hardware (scanners). (b) Software-acquisition sequences/MR protocols used (including slice thickness, pulse sequences). (c) Image analysis software for identifying and characterizing the size, shape, and volumes of various structures and discriminating various types of tissue (gray matter, white matter cerebrospinal fluid) on a global and regional basis. Please describe: c1) the measures derived through the use of the software; c2) the advantages of the software compared with other available image analysis software; c3) how automated the software is, e.g., how much manual intervention is required for its use; c4) the sorts of image acquisition protocols required to produce images for automated computerized image analysis using the software; and c5) the time required for analyzing data from one subject. (d) If you are currently involved in longitudinal studies: d1) Describe your data analytic strategies for both the cross sectional and longitudinal components of your study. d2) Describe how changes or upgrades in scanner software have been and are being dealt with, i.e., how data obtained with different versions of software are shown to be homogenous or how comparability of data acquired using different software is achieved. (e) Describe any anticipated software upgrades within the next year. 3. Your experience with children younger than 5 years of age: (a) Describe the conditions and circumstances under which MR scanning is done, such as, methods to obtain scans without using sedation and any special equipment and procedures available for young pediatric populations. (These might include audio or video presentations, special training procedures to desensitize young children or to train them to lie still, scanning during late night hours when children may fall asleep, etc.). (b) Describe the characteristics of subjects used as normal controls. B. With respect to functional MRI: 1. As in (A) above, your study samples: (a) Your existing study samples, as well as samples potentially available to you, including the ages of subjects you have successfully scanned. (b) Your procedures for recruitment and enrollment of study subjects, including outreach efforts and strategies. (c) The number of subjects with what diseases/disorders you have studied. (d) Documentation of your ability to recruit normal children for neuroimaging studies within a 12-15 month time period. Specify if your recruitment capabilities would be suited to a particular age range. (e) Demographic measures: age, gender, race, and socioeconomic composition available for your control and study samples. (f) Your current and proposed methods for defining "normality" within the age span of 0 to 18 years and your procedures for recruitment and enrollment of study subjects: histories (e.g., standardized forms); examinations (e.g., physical and neurological examination measures -- clinical, standardized, quantitative); and neuropsychological measures (e.g., IQ testing, neuropsychological and behavioral test batteries). 2. Your current image acquisition and analysis tools: (a) Hardware (scanners). (b) Software-acquisition sequences/MR protocols used. (c) Image analysis/data software and procedures. (d) If you are currently involved in longitudinal studies, describe your data analytic strategies for both the cross sectional and longitudinal components of your study. (e) Describe any anticipated software upgrades within the next year. 3. Any experience with children younger than 5 years of age (see #A.3. above). 4. The neurological and any cognitive functions studied and the tasks and paradigms used to study them. C. Estimated cost per subject, based on the current pricing structure established within your organization, associated with: 1. Clinical evaluations; 2. Neuropsychological test batteries to define normality; 3. MR imaging and analysis; and 4. Functional neuroimaging task costs. This Request For Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Government. The Government does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or the Government's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the Government's evaluation of the information received. However, should such a requirement materialize, no basis for claims against the Government shall arise as a result of a response to this request for information or the Government's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. All respondents are asked to indicate the type and size of your business organization, e.g., Large Business, Small Business, Small Disadvantaged Business, Women-Owned Business, 8(a), Historically Black College or University/Minority Institution (HBCU/MI), educational institution, profit/non-profit hospital, or other nonprofit organization, in their response. Responses should be identified with NINDS No. 98-RFI-01, and are due by May 29, 1998. Please submit three (3) copies of your response to the attention of : Raina Cervantes, Contracting Officer, Contracts Management Branch, National Institute of Neurological Disorders and Stroke, NIH, Federal Building, Room 901, 7550 Wisconsin Avenue, MSC 9190, Bethesda, Maryland 20892-9190. Facsimile responses will also be accepted as long as they do not exceed 20 pages in length. E-mail responses, sent to ec58q@nih.gov shall also be accepted. For you information, a collaborative Request for Proposals (RFP) will soon be released to establish a Data Coordinating Center for a pediatric MRI brain data base. An electronic version of the RFP may be accessed at the NIMH contracts page at http://www.nimh.nih.gov/grants/rfp.htm. (0112)

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