PEDIATRIC ANATOMIC NEUROIMAGING DATA BASE INITIATIVE

Release Date:  May 11, 1998

REQUEST FOR INFORMATION:  NINDS-98-RFI-01

P.T.

National Institute of Neurological Disorders and Stroke
National Institute of Mental Health
National Institute of Child Health and Human Development

The National Institute of Neurological Disorders and Stroke (NINDS), National
Institute of Mental Health, (NIMH), and National Institute of Child Health and
Human Development (NICHD) are putting forth an initiative to establish a
pediatric brain magnetic resonance imaging (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.

Background

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 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.

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. 
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.

Estimated cost per subject, based on the current pricing structure established
within your organization, associated with:

Clinical evaluations;
Neuropsychological test batteries to define normality;
MR imaging and analysis; and
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 non-profit
organization, in their response.

INQUIRIES

Responses should be identified with NINDS No. 98-RFI-01, and are due by May 29,
1998.  Please submit three copies of your response to:

Raina Cervantes
Contracts Management Branch
National Institute of Neurological Disorders and Stroke
7550 Wisconsin Avenue, Room 901, MSC 9190
Bethesda, MD  20892-9190
Email:  [email protected]

For your 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/indexcon.cfm.

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