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: grantsinfo@nih.gov. 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: bc129b@nih.gov 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: tf12w@nih.gov 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: pg38h@nih.gov 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.


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