and Human Services (HHS)
EXPIRED
LUNG IMAGE DATABASE RESOURCE FOR IMAGING RESEARCH
Release Date: April 10, 2000
RFA: CA-01-001
National Cancer Institute
Letter of Intent Receipt Date: June 9, 2000
Application Receipt Date: July 14, 2000
PURPOSE
The National Cancer Institute (NCI) invites applications from investigators
who are interested in joining a consortium of institutions to develop the
necessary consensus and standards for an image database resource and to
construct a database of spiral computed tomography (CT) lung images. There is
considerable interest in using spiral CT lung scanning for lung cancer
screening for patients at high risk. Early detection and intervention may
significantly reduce lung cancer mortality rates. The use of image processing
methods may be an important adjunct to facilitate spiral CT lung cancer
screening. Investigators developing image-processing algorithms need
standardized databases with which to work. The generation of standardized
databases requires the development of consensus on many issues related to
database design, accessibility, metrics and statistical methods for evaluating
image-processing algorithms. NCI therefore plans to establish a consortium of
institutions, called the Lung Image Database Consortium (LIDC), to develop
such consensus and the necessary database.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a
PHS-led national activity for setting priority areas. This Request for
Applications (RFA), Lung Image Database Resource for Imaging Research, is
related to the priority area of cancer. Potential applicants may obtain a
copy of "Healthy People 2010" at http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic and foreign 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. Applications may represent a single
institution, or may involve two or more affiliated institutions or
organizations if such affiliation is appropriate to the goals of this
initiative. NCI will form the Consortium from the selected awardees after
the individual applications are reviewed. Applicants to include more than
one institution should consult NCI program staff at an early stage of the
application preparation. Minority individuals, women, and persons with
disabilities are encouraged to apply as principal investigators.
MECHANISM OF SUPPORT
The administrative and funding instrument to be used for this program will be
a cooperative agreement (U01), an "assistance" mechanism (rather than an
"acquisition" mechanism), in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during performance
of the activity. Under the cooperative agreement, the NIH purpose is to
support and/or stimulate the recipient's activity by involvement in and
otherwise working jointly with the award recipient in a partner role, but it
is not to assume direction, prime responsibility, or a dominant role in the
activity. Details of the responsibilities, relationships and governance of
the study to be funded under cooperative agreement(s) are discussed later in
this document under the section "Terms and Conditions of Award."
The total project period for applications submitted in response to this RFA
may not exceed 5 years. The earliest anticipated award date is April 1,
2001.
Although this program is provided for in the financial plans of the NCI,
awards pursuant to this RFA are contingent upon the availability of funds for
this purpose.
This RFA is a one-time solicitation.
FUNDS AVAILABLE
The NCI intends to commit approximately $7 million total costs to the support
of this initiative over 5 years. The NCI intends to commit approximately
$1.3 million in FY 01 to fund approximately 5 grants in response to this RFA.
An applicant may request a project period of up to 5 years and a budget for
direct costs of up to $200,000 per year, excluding Facility and
Administrative costs on consortium arrangement. Because the nature and scope
of the research proposed might vary, it is anticipated that the size of each
award will also vary. Although the financial plans of the NCI provide
support for this program, awards pursuant to this RFA are contingent upon the
availability of funds and the receipt of a sufficient number of meritorious
applications. At this time, it is not known if competing renewal applications
will be accepted and/or if this RFA will be reissued.
RESEARCH OBJECTIVES
Background
Preliminary clinical studies show that spiral CT scanning of the lungs can
improve early detection of lung cancer in high-risk individuals. However,
more clinical data are needed before public health recommendations can be made
for population-based screening. Image processing algorithms have the potential
to assist in lesion (e.g., nodule) detection on spiral CT studies, and to
assess the stability or change in size of lesions on serial CT studies. The
use of such computer-assisted diagnosis (CAD) image processing algorithms
could significantly enhance the sensitivity and specificity of spiral CT lung
screening, as well as lower costs by reducing the physician time needed for
interpretation.
Electronic image detectors such as those used in contemporary spiral CT
scanners acquire more information than can be displayed at any one time, using
standard display methods. Therefore, research on image processing methods is
essential to fully exploit the information that has been acquired.
Furthermore, ability to extract quantitative information from images is
increasingly important and requires image processing. Investigators working
on image processing frequently do not have access to or the resources
necessary to create the large databases of images necessary to develop and
test their work. In addition, the comparison and evaluation of image
processing techniques against each other require common data sets and
standardized methods for evaluation. The need for medical image databases as
research resources for medical image processing has often been identified as a
priority at various NIH workshops [e.g., the NCI Lung Imaging Workshop and
related Technology Transfer of January 1997, Image Processing Workshop of
October 1998, and the NIH Biomedical Imaging Symposium of June 1999].
Previous efforts to create image databases and make them widely available have
met with limited success partly due to lack of consensus on critical issues.
An example of the establishment of a successful image database as an
international resource is the National Library of Medicine (NLM) Visible Human
Project (VHP) initiated in 1989. This project was partly supported by the
National Science Foundation (NSF). VHP has proven to be far more useful than
imagined at its inception. It created a resource of CT and MRI images of male
and female human cadavers, along with photographs of the corresponding cadaver
sections. This resource is continually used around the world for research and
educational purposes. NLM is currently supporting work to develop
generalizable algorithms for segmentation and alignment using the VHP.
Another example of an image database resource in development is the NIH
collaborative effort called the Human Brain Project (HBP), begun in 1993, that
seeks to create common tools to facilitate research on neuroinformatics. This
project was also partly supported by NSF. Some of these tools are image-
processing algorithms for neuroimaging such as brain CT, PET and MRI studies.
The solutions that the VHP develops for normal anatomy, and that the HBP
develops for brain imaging, will not necessarily transfer directly to other
organ systems, but NCI will encourage exchange of information among the
investigators supported by this initiative (LIDC), the VHP and the HBP.
Computer-assisted diagnosis is a general term used for a variety of artificial
intelligence techniques applied to medical images. CAD methods are being
rapidly developed at several academic and industry sites, particularly for
large-scale breast, lung, and colon cancer screening studies. Imaging for lung
cancer screening is a good physical and clinical model for the development of
image processing and CAD methods, related image database resources, and the
development of common metrics and statistical methods for evaluation.
Automatic target recognition algorithms are one example of CAD. For large-
scale screening applications, automatic target recognition is an important
method for: (a) improving the sensitivity of cancer detection, (b) reducing
observer variation in image interpretation, (c) increasing the efficiency of
reading large image arrays, (d) improving efficiency of screening by
identifying normal images, and (e) facilitating remote reading by experts.
Image processing tools are also being developed for temporal analysis of
serial images, with the aim of detecting early subtle changes that might not
be obvious to the reading physician. In addition, CAD techniques can improve
the specificity of cancer detection by assigning a quantitative estimate of
the probability that a detected lesion is benign or malignant. Another
promising application of CAD is predicting which cases are most suitable for a
particular treatment option. These types of CAD require consensus on such
issues as the development of reference standards (electronic ground truth),
software modules for registration of serial images and related image
segmentation.
Multimodality imaging (X-ray CT, MRI or PET/SPECT) will also be important for
diagnostic image interpretation. Therefore, development and implementation of
multimodality image registration software is desirable. Finally X-ray CT image
reconstruction methods may also influence the performance of CAD methods and
hence the collection of raw image data needs to be considered in the design of
an image database that is intended to be a general resource.
Objectives and Scope
Introduction
The intent of this initiative is to support a consortium of institutions to
develop consensus guidelines for a spiral CT lung image resource, and to
construct a database of spiral CT lung images. The investigators funded
under this initiative will create a set of guidelines and metrics for
database use and develop a database as a test-bed and showcase for those
methods. The database created by this consortium will be available to all
researchers and users through the Internet, and will have wide utility as a
research, teaching and training resource.
Specific goals of the RFA:
(1) Create a consortium (LIDC) to develop consensus guidelines for: (a)
preparation and submission of lung CT cases that are representative of
clinical practice, (b) reference standards ( ground truth ) for spatial
determination of imaged lesions(s) electronically in 3 dimensions (3D) (c)
standards for histologic verification of image lesion(s), (d) common metrics
and software for statistical validation of the performance of image
processing methods;
(2) Create an image database as a common research resource to the medical
imaging community to: (a) permit early identification of promising software
methods from the diverse pool of emerging tools, (b) stimulate the
development of advanced image processing methods including temporal analysis,
and image registration;
(3) Allow Internet access to the database by the broad imaging research
community to stimulate inter-disciplinary research collaboration among
researchers in academia, government and industry. Internet access will be
accomplished by using the resources of the NIH to develop and provide the
necessary infrastructure, with image access using DICOM standards.
It is anticipated that approximately 5 individual academic sites will be
supported. There is a critical need to have broad representation from the
medical imaging community to promote the development of consensus and
establishment of standards. To ensure a representative database is collected,
the final criteria for selection of awardees will include a requirement for
the inclusion of different awardees representing a minimum of three different
institutions and images from at least two different spiral CT X-ray imaging
devices (i.e., from 2 different manufacturers). The individual awardee
institutions do not need to provide images from more than one CT scanner
manufacturer. In creating the Consortium as a whole, NCI staff will ensure
that images from at least two different scanner manufacturers will be
included. The generation of image subsets of either CT raw data or
multimodality images is an optional secondary goal and thus no specific
requirements are posed. The Consortium will determine, after it is formed,
what datasets of raw data and multimodality images will be useful and are
practical to obtain.
SPECIAL REQUIREMENTS
In order to ensure maximum progress in the projects funded by this initiative
and to realize the maximum benefit for the cancer research community and
ultimately for the ongoing battle against cancer, several special activities
will be required of the funded investigators. Grantees will be required to
develop a plan for the timely release of data to the cancer research
community. The LIDC will be directed by a Steering Committee (see Section 3
below) which must meet together on a regular basis.
Applicants should state in their applications their commitment to
participating in these group activities and their commitment to the public
release of data.
o The Steering Committee will organize a public meeting in year 2, open to
all interested researchers working on image processing algorithm development
and evaluation, to seek feedback on the plans for the database generation and
evaluation. Attendance at this meeting should be budgeted for.
o Conference calls of the Steering Committee and NCI program staff will be
organized on a monthly basis to manage this project. Funds must be budgeted
for these.
o The funding available for this initiative is specifically not to be used
to perform the spiral CT scans. The applicants should address the source and
funding for the lung CT images and the corroborative data that would be made
available to the public database.
The following terms and conditions will be incorporated into the award
statement provided to the Principal Investigator(s) as well as the
institutional official at the time of award.
Terms and Conditions of Award
These special Terms of Award are in addition to and not in lieu of otherwise
applicable OMB administrative guidelines, HHS Grant Administration
Regulations at 45 CFR Parts 74 and 92, and other DHHS, PHS, and NIH Grant
Administration policy statements. [Part 92 applies when state and local
governments are eligible to apply as a "domestic organization."]
As stated above, the administrative and funding instrument used for this
program is a cooperative agreement (U01), an "assistance" mechanism (rather
than an "acquisition" mechanism) in which substantial NIH scientific and/or
programmatic involvement with the awardee is anticipated during performance
of the activity. Under the cooperative agreement, the NIH purpose is to
support and/or stimulate the recipient's activity by involvement in and
otherwise working jointly with the award recipient in a partner role, but it
is not to assume direction, prime responsibility, or a dominant role in the
activity. Consistent with this concept, the dominant role and prime
responsibility for the activity resides with the awardee(s) for the project
as a whole, although specific tasks and activities will be carried out as a
collaboration among the awardees with coordination and facilitation by NCI
Program Staff.
1. Awardee Rights and Responsibilities
Awardees will have primary responsibility for the project as a whole,
including research design and conduct, data collection, data quality control,
data analysis and interpretation and preparation of publications, as well as
collaborations with other awardees. An NCI Program Staff member will
coordinate and facilitate interactions and collaborations among the awardees
(see section 3 below).
The primary purpose of the initiative is the creation of consensus guidelines
and a database available to medical researchers. Within these constraints,
awardees will retain custody of, and primary rights to, the data developed
under these awards, subject to Government right of access consistent with
current DHHS, PHS, and NIH policies. Awardees must commit to the timely
release of the data to the cancer research community through a mechanism and
procedures to be planned and implemented by the awardees and the NCI.
Awardees will be required to accept and implement the common protocol and
procedures approved by the Steering Committee (see Section 3 below).
2. NCI Staff Responsibilities
NCI Program staff will work closely with individual consortium investigators
to facilitate collaborations within the consortium and with other NCI-funded
research groups to ensure that all investigators have access to the image
database and other resources that may be necessary to successfully achieve
their research goals. The NCI Program Director responsible for the
individual awards will assist in the coordination of activities that involve
all of the awardees such as the planning meetings.
NCI Program Director and Imaging Technology Development Branch Chief will
participate in and facilitate the development of the strategies for making
database access widely available within the consortium and to the imaging
research community. The NCI Program Director and Imaging Technology
Development Branch Chief will be voting members of the Steering Committee but
cannot serve as chair and will coordinate and facilitate the work of the
Steering Committee (see Section 3 below).
3. Collaborative Responsibilities
A Steering Committee will be the main governing board of the LIDC, and will be
composed of the PI of each awarded grant, a second member from each awarded
grant selected by the PI, and the NCI Program Director and Imaging Technology
Development Branch Chief. Each of these members will have one vote. The
chairperson, who will be someone other than an NCI staff member, will be
selected by the Steering Committee.
The Steering Committee will have primary responsibility for implementation of
the overall goals of the Consortium, refining the scope of the original
applications submitted so that the work of the Consortium as a whole is
integrated, and organizing research tasks for each participating site where
necessary. The Steering Committee’s responsibilities will include efforts to
reach consensus on the criteria to populate the image database, to monitor the
accrual of cases, to monitor image quality control, to review ground truth and
related pathological confirmation to ensure commonality of methods at each
site, to determine whether raw data will be incorporated in the database, to
decide what multi-modality images to include, to expand the database if
improved CT imaging sensors become available, to reach a consensus on the
metrics and statistical methods for software evaluation, and to ensure DICOM
standards are followed for image transfer and all patient related information.
The Steering Committee will be responsible for determining the image format
and the mode of transfer to NIH for Internet general access. The Steering
Committee will continue to monitor the implementation of the data release plan
for the life of the awards. It will also be responsible for the collaboration
with other NCI-supported clinical trials where applicable (e.g., the ACRIN
Cooperative Group), for establishing procedures for access to image databases
and for ensuring appropriate selection of imaging protocols. It will also be
encouraged to interact with professional societies such as Radiological
Society of North America and American College of Radiology, with government
agencies such as NSF, and other NIH cooperative groups generating image
databases (e.g., Human Brain Project, Visible Human Project) to ensure
community acceptance of standards proposed for evaluation of the image data
bases. The Steering Committee will facilitate the conduct of studies and
reporting and publication of study results. Subcommittees will be established
by the Steering Committee, as it deems appropriate; the NCI staff members will
serve on subcommittees, as deemed appropriate by the Steering Committee.
The Steering Committee will review database submissions, follow-up
information on cases selected for inclusion in the database, protocol and
DICOM compliance, results of audits, and regulatory requirements at the
participating centers, and formally report the results of its reviews to the
NCI in writing. The format and time intervals of such reports will be
decided by the Steering Committee.
The Steering Committee will meet three times in year 1 and two times per year
in subsequent years. The Steering Committee will be responsible for the
organization of a public meeting in year 2, open to all interested
researchers working on image processing algorithm development and evaluation,
lung cancer screening, image databases, or any related activity, to seek
feedback on the plans for the database generation and evaluation.
4. Arbitration
Any disagreement that may arise on scientific/programmatic matters (within
the scope of the award) between award recipients and the NCI may be brought
to arbitration. An arbitration panel will be composed of three members --
one selected by the LIDC Steering Committee (with the NCI members not voting)
or by the individual awardee in the event of an individual disagreement, a
second member selected by NCI, and a third member selected by the two prior
selected members. This special arbitration procedure in no way affects the
awardee's right to appeal an adverse action that is otherwise appealable in
accordance with the PHS regulations at 42 CFR Part 50, Subpart D and DHHS
regulation at 45 CFR Part 16.
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 sub populations 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.
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 28,
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: http://grants.nih.gov/grants/guide/notice-files/not94-100.html
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://grants.nih.gov/grants/guide/notice-files/not98-024.html
Investigators may also obtain copies of the policy from the program staff
listed under INQUIRIES.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
LETTER OF INTENT
Prospective applicants are asked to submit, by June 9, 2000, a letter of
intent that includes a descriptive title of the proposed research, name,
address, and telephone number of the Principal Investigator, identities of
other key personnel and participating institutions, and number and title of
the RFA in response to which the application may be submitted.
Although a letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications, the information allows NCI
staff to estimate the potential review workload and plan the review.
The Letter of Intent is to be sent to Dr. Barbara Croft listed under
INQUIRIES by the letter of intent receipt date listed.
APPLICATION PROCEDURES
The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants. Applications 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]. For those
applicants with Internet access, the 398 kit may be found at
http://grants.nih.gov/grants/forms.htm
General guidelines and format.
The format should follow the general guidelines for PHS 398. The applicant
may include a discussion of some or all of the following topics in the
appropriate sections a-d of the Research Plan. These topics are offered by
way of example only.
o A review of the challenges posed by the research objectives of this RFA,
and the institution’s preliminary experience, such as spiral CT imaging
protocols for screening and diagnostic follow-up studies, radiation dose
considerations, image reconstruction, image quality control, system for
collecting patient-related information, DICOM standards for image transfer,
image archive and computer network resources, population and development of
image data bases, optimization and evaluation of related algorithms. In
addition, consider describing multi-modality imaging protocols, if
implemented, and proposals for creating sub-sets of database images from
these modalities, as an optional secondary goal for the LIDC.
o Level of institution’s commitment to maintain lung cancer screening
programs and state-of-the-art CT imaging methods during the time of these
awards.
o Institutional IRB issues related to the collection of patient data and
data analysis in the context of this project. The databases should contain
demographic and clinical information relevant to the software validation
process (e.g., risk factors), but not individual identification data.
o Challenges posed by image noise characteristics that may affect the
performance of image processing methods, and the feasibility of including
sub-sets of raw data to explore alternative image reconstruction methods.
o Methods for obtaining pathological confirmation of lung nodule(s) by
biopsy or other means, anticipated sampling errors, means for obtaining
spatial ground truth (GT) and methods to validate image registration and
temporal analysis methods.
o Methods proposed to populate the image database in terms of: (a) the
total number of patient cases, (b) means for selection of representative
cancer, benign and normal cases, (c) methods for selection of subsets of
cases with varying level of difficulty, (c) criteria for selection of cases
for serial or multi-modality imaging, and (d) criteria for selection of sub-
sets of cases for training and or testing of image processing algorithms and
means to avoid bias in case selection.
o Means to allow data mining for sub-sets of cases depending on
researchers needs and methods to achieve interoperability with databases
developed by other NIH activities (such as VHP and HBP).
o Approach to obtain consensus for the development of common performance
metrics, such as measuring detection events or the accuracy of image
registration. Similarly, common statistical evaluation criteria for proposed
image processing and CAD software may also be discussed.
o An overall management plan for the Consortium.
Applicants should request travel funds to attend two meetings per year of the
Steering Committee (three meetings in the first year). In the first year,
applicants should plan for 2 investigators, the principal investigator and an
additional senior investigator, to attend 3 Steering Committee meetings. In
the subsequent years, applicants should plan for the PI and another
investigator to attend 2 Steering Committee meetings per year. The Steering
Committee will organize a public meeting in year 2; attendance at this
meeting should be budgeted for. Funds must be budgeted for monthly
conference calls of the Steering Committee.
The funding available for this initiative is specifically not to be used to
perform the spiral CT scans. The applicants should address the source and
funding for the lung CT images and the corroborative data that would be made
available to the public database.
The RFA label available in the PHS 398 (rev.4/98) application form must be
affixed to the bottom of the face page of the application. Type the RFA
number on the label. Failure to use this label could result in delayed
processing of the application such that it may not reach the review committee
in time for review. In addition, the RFA title, LUNG IMAGE DATABASE RESOURCE
FOR IMAGING RESEARCH, and number, CA-01-001, must be typed on line 2 of the
face page of the application form and the YES box must be marked.
The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to
allow for this change. Please note this is in pdf format.
Submit a signed, typewritten original of the application, including the
Checklist, and three signed photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, MD 20892-7710
(20817 for express service)
At the time of submission, two additional copies of the application must also
be sent to:
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8062, MSC-8239
Rockville, MD 20850 (express courier)
Bethesda, MD 20892-8239
Applications must be received by July 14, 2000. If an application is
received after that date, it will be returned to the applicant without
review. The Center for Scientific Review (CSR) will not accept any
application in response to this announcement that is essentially the same as
one currently pending initial review, unless the applicant withdraws the
pending application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an application already reviewed, but
such an application must follow the guidance in the PHS Form 398 application
instructions for the preparation of revised applications, including an
introduction addressing the previous critique.
REVIEW CONSIDERATIONS
Upon receipt, applications will be reviewed for completeness by CSR and
responsiveness by the National Cancer Institute. Incomplete and/or non-
responsive applications will be returned to the applicant without further
consideration.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the Division of Extramural Activities of the National Cancer
Institute in accordance with the review criteria stated below. 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 the applications under
review, will be discussed, assigned a priority score, and receive a second
level review by the National Cancer Advisory 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 the database 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
U01? Does the applicant acknowledge potential problem areas and consider
alternative tactics? Does the investigator demonstrate a commitment to
cooperation with the other funded investigators in the LIDC and with NCI
program staff in the development of a plan to create the database and the
evaluation methodology and to make the database and other results available
to the research community in a timely manner?
3. Innovation. Does the project employ concepts, approaches or methods that
are recognized as state of the art and acceptable as reference methods? 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)? Is there
demonstrated experience in the generation of spiral CT databases for lung
cancer screening, case selection criteria, groung truth determination, and
pathological confirmation? Does the investigator have experience with image
processing methods, such as optimization, evaluation and image registration
methods using spiral CT or multi-modality imaging? Is there experience with
CT image reconstruction methods? Is there evidence of knowledge of metrics
and statistical criteria for evaluation of imaging processing algorithms,
including temporal analysis methods?
5. Environment. Does the scientific environment in which the work will be
done contribute to the probability of success? Is there evidence of
institutional support for lung cancer screening programs? Is there access to
state-of-the-art imaging sensors, namely spiral CT? Is the organization
experienced in CT quality control and DICOM standards for image transfer and
patient information documentation? What is the extent and design of the
applicants existing image databases and corroborative data? What is the
commitment and ability to accrue more cases as needed? Are human subjects
issues which would interfere with the creation of a database addressed?
The initial review group will also examine: the appropriateness of proposed
project budget and duration; the adequacy of plans to include both genders
and minorities and their subgroups as appropriate for the scientific goals of
the research and plans for the recruitment and retention of subjects; the
adequacy of plans for including children as appropriate for the scientific
goals of the research, or justification for exclusion; the provisions for the
protection of human and animal subjects; and the safety of the research
environment.
AWARD CRITERIA
Applications recommended by the National Cancer Advisory Board will be
considered for award based upon (a) scientific and technical merit; (b)
program balance, including in this instance, the desire to have at least 3
different institutions and 2 different manufacturers' equipment represented
in the Group; (c) geographic distribution; and (d) availability of funds.
SCHEDULE
Letter of Intent Receipt: June 9, 2000
Application Receipt Date: July 14, 2000
Peer Review Date: October or November 2000
Review by NCAB Advisory Board: February 2001
Earliest Anticipated Start Date: April 1, 2001
INQUIRIES
Written and telephone inquiries concerning this RFA are encouraged. The
opportunity to clarify any issues or questions from potential applicants is
welcome.
Direct inquiries regarding scientific responsiveness and programmatic issues
to:
Barbara Y. Croft, Ph.D.
Biomedical Imaging Program
National Cancer Institute
6130 Executive Plaza, Room 800
Bethesda, MD 20892
Telephone: (301) 496-9531
Fax: (301) 480-5785
Email: [email protected]
Direct inquiries regarding review issues to:
Ms. Toby Friedberg
Referral Officer
Division of Extramural Activities
National Cancer Institute
6116 Executive Blvd., Room 8062, MSC-8239
Rockville, MD 20852 (express courier)
Bethesda MD 20892-8239
Telephone (301) 496-3428
Fax: (301) 402-0275
Email: [email protected]
Direct inquiries regarding fiscal matters to:
Priscilla Grant
Grants Administration Branch
National Cancer Institute
Executive Plaza South, Room 243
6120 Executive Boulevard, MSC 7150
Bethesda, MD 20892-7150
Telephone: (301) 496-3160
Fax: (301) 496-8601
Email: [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 Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and administered under NIH grants policies and
Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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