DEVELOPMENT OF DIGITAL MAMMOGRAPHY DISPLAYS AND WORKSTATIONS

Release Date:  April 13, 1999

PA NUMBER: PA-99-082

P.T.

National Cancer Institute

PURPOSE

The purpose of this Program Announcement is to alert the investigator community
to the need for and NCI interest in a concerted effort to overcome the problems
of display for digital mammograms.  The problem cannot be solved simply with
computer programming or hardware improvements alone.  Integration of  advanced
hardware, software, and psychophysics research data is needed to optimize the
early diagnosis of breast cancer using digital mammography. Small businesses are
encouraged to consider a parallel program announcement of identical scientific
scope that utilizes the SBIR and STTR mechanisms.  Another PA is concurrently being issued (PA-99-083).  
This RFA is available at:  http://www.nih.gov/grants/guide/pa-files/PA-99-083.html).

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This PA, Development of Digital Mammography
Displays And Workstations, is related to the priority area of cancer.  Potential
applicants may obtain a copy of "Healthy People 2000" (Full Report:  Stock No.
017-001-00474-0 or Summary Report:  Stock No. 017-001-00473-1) through the
Superintendent of Documents, Government Printing Office, Washington, DC
20402-9325 (telephone 202-512-1800), or at
http://www.crisny.org/health/us/health7.html.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and domestic, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of the
Federal government.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) research project grant
(R01) award mechanism.  Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant.

Beginning with the June 1, 1999 receipt date, "MODULAR GRANT APPLICATION AND
AWARD" procedures will apply to all competing individual research project grants
(R01), small grants (R03), and exploratory/developmental grants (R21)
applications requesting up to $250,000 direct cost per year (see the NIH Guide,
December 15, 1998).

Specific instructions for MODULAR GRANTS are mentioned under APPLICATION
PROCEDURES to reflect the process which has been adopted by the NIH.  More
detailed information about modular grant applications, including a sample budget
narrative justification pages and a sample biographical sketch, is available via
the Internet at url: http://www.nih.gov/grants/funding/modular/modular.htm

RESEARCH OBJECTIVES

Background

Digital Mammography is one of the most promising research areas for improving
early detection of breast cancer. Experts in the field agree that current
softcopy (i.e., video) display systems remain an impediment to full realization
of the potential of digital mammography.  Softcopy display is essential for
optimizing the use and display of digital mammography data, both in the research
and clinical setting.

On March 9-10, 1998 in Washington, DC, the Public Health Service's Office on
Women's Health and the National Cancer Institute assembled a Joint Working Group
on Digital Mammography: Digital Displays and Workstation Design.  The meeting,
attended by over 100 scientific leaders, was convened to achieve the following
goals: 1) To review the state-of-the-art of display technologies, including
current and future clinical applications and technical challenges; and 2) To
outline research priorities in digital display technology and workstation design.
This Program Announcement is based on the recommendations and research agenda
developed by the Working Group.

Little research has been done on the hardware, software, and psychophysical
issues involved in workstation design.  Further extensive effort is required for
the successful development, testing and implementation of digital mammography
displays and workstation design for image interpretation.  Manufacturers of
digital mammography systems have generally adapted existing workstations,
developed for CT or MRI, to their digital mammography units.  The dearth of data
on perceptual issues, software applications and hardware comparisons impedes
development of optimal workstations.  Data from observer studies are needed. 
Since mammography demands greater spatial and contrast resolution than any other
clinical area of radiology, it is likely that results obtained from research
targeted toward meeting the needs of mammography will have beneficial effects on
other areas of clinical imaging as well.

Program Initiative

The goal of this program initiative is to advance the state-of-the-art in digital
mammography displays and workstation design in order to obtain the full potential
of digital mammography for improved breast cancer diagnosis.  This PA solicits
research and development in three inter-related areas relevant to digital
mammography: 1) Video Display Hardware; 2) Workstation Software and Design; and
3) Image Perception.  Although these are somewhat distinct areas of research
endeavor, it is important to integrate advances in all three areas in order to
obtain optimal utilization of the image data.

I. Softcopy Display Hardware.

A. Required Features

Digital mammography examinations produce data sets immensely larger than can be
presented or perceived at one time with currently available monitor or flat-panel
display technology.  A digital mammographic examination generates four images of
20 to 200 megabytes each.  A screening study will usually be compared to a prior
exam, and these eight images are the typical data set the radiologist must
interpret.

Direct-view display technologies capable of high brightness and high spatial
resolution are considered to be appropriate candidates for mammography display. 
Current display technologies for 2500 x 3000 pixel images may be suitable for
digital mammography if software functions can help overcome such display
limitations as spatial resolution, limited luminance, and dynamic range. However,
objective data on display performance for clinical tasks are lacking.

B. Examples of Research Priorities for Softcopy Display Hardware

1.  Studies are needed to objectively evaluate display technologies for
mammographic imaging. For example, it is necessary to determine the relation
between the visibility of early signs of breast cancer (such as mass,
microcalcifications, architectural distortion, skin and nipple changes), and
digital display performance parameters (such as luminance, dynamic range, spatial
and contrast resolution and noise characteristics).

High resolution display technologies providing high spatial and contrast
resolution, high luminance, high dynamic range and wide viewing angle at
reasonable cost need to be developed.  For example, research is needed on
materials and device structures for new display technologies.

II. Image Perception

A. Required Features

It has been estimated that at least half of mammography errors are due to faulty
image perception. The efficiency of human perception is influenced by  (1) the
matching of the physical properties of the display to the visual system, (2) the
working environment, (3) the computer interface, (4) the expertise of the
observer, and (5) human factors for both the patient and the observer.  Research
is needed to understand digital display systems and clinical environment
tradeoffs that affect the detection and discrimination of abnormalities in
mammography and to use this information to guide development of hardware,
software and user interfaces.  Predictive models should be developed that
indicate how to improve human performance by changes in images, detectors,
displays, and the environment. Testing every change in the physical parameters
of an imaging system on decision outcome is not feasible. A predictive model
would be much more useful, and scientific effort should be expended on model
development.

B.  Examples of Research Priorities for Image Perception

1.  Perform psychophysical studies of the effect of display parameters on
detection and discrimination of diagnostic features in mammograms.

2.  Determine the effect of image navigation and different display protocols on
the detection and discrimination of diagnostic features in mammograms.

3.  Develop an improved understanding of design factors for the image reading
environment.

4.  Perform studies to optimize the human user interaction (ergonomics).

5.  Develop computational perception models appropriate for predicting human
detection and discrimination performance using real mammograms, to enable
optimization of display characteristics without the lengthy and prohibitively
costly process of trial-and-error.

6.  Investigate user preference issues with respect to CAD and user directed
image processing and manipulation tools.

7.  Study and quantify the effects of fatigue and vigilance during screening
tasks.

III. Workstation Software and Design

A. Required Features

Softcopy workstations are not currently optimal for mammography.  Workstation
designs must take into account radiologists' needs for both screening and
diagnostic mammography.  Speed and intuitive image review are of paramount
importance. A softcopy workstation must be capable of displaying at least 2
different images at once for comparison; there is typically at total of 8 images
under consideration (2 views of each breast, current and prior). With current
detector technology, this means that workstations must be capable of handling 200
Mbytes or more of raw image data per examination.

For diagnostic studies, film arrangement and manipulation are much more variable
than in screening, and present even greater challenges.  Diagnostic studies
require additional, tailored mammographic views, other modalities (e.g.,
ultrasound, MRI), and techniques (e.g., image analysis, digital tomosynthesis).

Timely display is also important.  Workstations must permit the radiologist to
navigate through hundreds of megabytes of data at speeds approaching those of the
head and eye movements of the radiologist.  It must be possible to load images
rapidly and retrieve other examinations from archives quickly and efficiently.

To make full use of the digital nature of the images, workstations must provide
easy-to-use image manipulation tools, such as contrast, brightness, image re-
ordering, selection of regions of interest, magnification, and other methods to
provide quantitative measurements from the image.

Workstations must be compliant with the DICOM standard, and be capable of
displaying digital mammograms from all DICOM-compliant acquisition systems.
Workstations must accommodate alternative acquisition schema that provide
complementary information (e.g., CAD, stereotaxy, tomosynthesis, digital
subtraction angiography, dual energy subtraction, etc.).  Workstation design also
should facilitate interfacing the digital system with radiology/hospital
information systems (RIS/HIS).

Workstations should also support quality control functions for the digital
mammography acquisition system as well as for displays, and facilitate
quantitative use of digital image data for quality control testing.  This would
allow objective testing of imaging performance and might reduce some of the costs
currently associated with quality control.

B.  Examples of Research Priorities for Workstation Software and Design

1.  Model radiologists' viewing and work patterns in both screening and
diagnostic environments so that critical parameters of work flow can guide
workstation design.

2.  Develop image management and navigation software based on the above modeling.

3.  Define default softcopy image parameters (e.g., contrast resolution, spatial
resolution, maximum luminance, background luminance, and system contrast).

4.  Develop display-specific compensations to permit fidelity of default images
(i.e., compensate for variables such as absolute luminance, luminance non-
uniformity, veiling glare, dynamic range, distortion, noise, modulation transfer,
luminance range, and acquired image size so that default images are the same
regardless of specific display device).

5.  Develop quality control techniques to assure fidelity of standard images
regardless of specific displays.

6.  Develop and evaluate feature specific enhancement algorithms (e.g., for
calcifications, masses or architectural distortion).

7.  Expand work on current CAD algorithms to increase sensitivity and
specificity.

8.  Improve display controllers to provide greater speed of image manipulation,
application of nonlinear lookup tables, image zooming and re-positioning, etc.

9.  Evaluate utility and image quality of various methods of image compression
for storage and data transfer.

10.  Utilize findings from studies such as those suggested above and state-of-
the-art technologies to assemble softcopy workstations for digital mammography
for both screening and  diagnosis.  Incorporate above work on image perception,
feature-specific image processing, CAD and user control issues into workstation
design. Evaluate  impact on diagnostic accuracy, time efficiency, cost, reader
fatigue, and satisfaction of search in both screening and diagnostic
environments.

Summary

Broadly, it is desired to improve and enhance the detection of breast cancer with
digital mammography by improving the entire system of softcopy reading of
mammograms.  This includes softcopy displays, the workstation design, ergonomics,
and an increased understanding about what properties of the display and
workstation are important for accurate diagnosis.  The examples mentioned above
are not inclusive; investigators are invited to include their own research
priorities.


INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included  in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided that inclusion is inappropriate with
respect  to the health of the subjects or the purpose of the research.  This 
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).

All investigators proposing research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which have been published in the Federal Register of March 20, 1994
(FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994 available on the web at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not94-100.html

Investigators also may obtain copies of  the policy from the program staff listed
under INQUIRIES.  Program staff may also provide additional relevant information
concerning the policy.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH that children (i.e., individuals under the age of 21)
must be included in all human subjects research, conducted or supported by the
NIH, unless there are clear and compelling scientific and ethical reasons not to
include them. This policy applies to all initial (Type 1) applications submitted
for receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for Grants
and Contracts, March 6, 1998, and is available at the following URL address:
http://www.nih.gov/grants/guide/notice-files/not98-024.html

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated in
the application kit.  Application kits are available at most institutional
offices of sponsored research and may be obtained from the Division of Extramural
Outreach and Information Resources,  National Institutes of Health, 6701
Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, E-
mail: [email protected].  The title and number of the program announcement must
be typed in Section 2  on the face page of the application.  The yes box must be
marked. For those applicants with internet access, the 398 kit may be found at
http://www.nih.gov/grants/forms.htm

Applicants planning to submit an investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended/revised version of
the preceding grant application types requesting $500,000 or more in direct costs
for any year are advised that he or she must contact the Institute or Center (IC)
program staff before submitting the application, i.e., as plans for the study are
being developed.  Furthermore, the application must obtain agreement from the IC
staff that the IC will accept the application for consideration for award.
Finally, the applicant must identify, in a cover letter sent with the
application, the staff member and Institute or Center who agreed to accept
assignment of the application.

This policy requires an applicant to obtain agreement for acceptance of both any
such application and any such subsequent amendment.  Refer to the NIH Guide for
Grants and Contracts, March 20, 1998 at 
http://www.nih.gov/grants/guide/notice-files/not98-030.html

SEE SPECIFIC APPLICATION INSTRUCTIONS BELOW FOR MODULAR GRANT APPLICATIONS.

The completed original application and five legible copies must be sent or
delivered to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

These instructions apply to applications requesting up to $250,000 direct cost
per year.

o  FACE PAGE:  Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments) and Total Costs [Modular Total Direct plus Facilities and
Administrative (F&A) costs] for the initial budget period.  Items 8a and 8b
should be completed indicating the Direct and Total Costs for the entire proposed
period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398.  It is not required and will not be accepted with the
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required and
will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page.
(See http://www.nih.gov/grants/funding/modular/modular.htm for sample pages.) 
At the top of the page, enter the total direct costs requested for each year.

o  Under Personnel, list key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should be
provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct plus
facilities and administrative) for each year, each rounded to the nearest $1,000. 
List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project.  The total cost for a  consortium/contractual arrangement is
included in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall qualifications
of the research team.  A biographical sketch is required for all key personnel,
following the instructions below.  No more than three pages may be used for each
person.  A sample biographical sketch may be viewed at:
http://www.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List current position(s) and then previous positions;
- List selected peer-reviewed publications, with full citations;
- Provide information, including overall goals and responsibilities, on research
projects ongoing or completed during the last three years.

o  CHECKLIST - This page should be completed and submitted with the application. 
If the F&A rate agreement has been established, indicate the type of agreement
and the date. It is important to identify all exclusions that were used in the
calculation of the F&A costs for the initial budget period and all future budget
years.

Applications requesting up to $250,000 direct cost per year and not conforming
to these guidelines will be considered unresponsive to this PA and will be
returned without further review.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral
guidelines.  Applications will be evaluated for scientific and technical merit
by an appropriate scientific review group convened in accordance with the
standard NIH peer review procedures.  As part of the initial merit review, all
applications will receive a written critique and undergo a process in which only
those applications deemed to have the highest scientific merit, generally the top
half of applications under review, will be discussed, assigned a priority score,
and receive a second level review by the appropriate national advisory council
or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  The
reviewers will comment on the following aspects of the application in their
written critiques in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals.  Each of these
criteria will be addressed and considered by the reviewers in assigning the
overall score weighting them as appropriate for each application.  Note that the
application does not need to be strong in all categories to be judged likely to
have a major scientific impact and thus deserve a high priority score.  For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.

1.  Significance.  Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced?  What
will be the effect of these studies on the concepts or methods that drive this
field?

2.  Approach.  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

3.  Innovation.  Does the project employ novel concepts, approaches or method? 
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?

4.  Investigator.  Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?

5.  Environment.  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research.  Plans for
the recruitment and retention of subjects will also be evaluated.

o  The reasonableness of the proposed budget and duration in relation to the
proposed research

o  The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project proposed
in the application.

The initial review group will also examine the provisions for the protection 
human subjects and the safety of the research environment.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications.  The following will be considered in making funding decisions: 
Quality of the proposed project as determined by peer review, availability of
funds, and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to:

Barbara Y. Croft, Ph.D.
Diagnostic Imaging Program
National Cancer Institute
6130 Executive Boulevard, Room 800
Bethesda, MD  20892
Telephone:  (301) 496-9531
FAX:  (301) 480-5785
Email: [email protected]

Direct inquiries regarding fiscal matters to:

Ms. Kathleen Shino, MBA
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Room 243
Bethesda, MD  20892-7150
Telephone:  (301) 496-7800 Ext. 248
FAX:  (301) 496-8601
Email:  s[email protected]

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.394 (Cancer Detection and Diagnosis Research).  Awards are made under
authorization of the Sections 301 and 405 of the Public Health Service Act as
amended ( 42 USC 241 and 284) and administered under PHS  grants policies and
Federal Regulations 42 CFR 52 and 45 CFR Part 74 and Part 92.  This program is
not subject to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

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