In Vivo Cellular and Molecular Imaging Centers (ICMICs).

The Cancer Imaging Program, a program of the Division of Cancer Diagnosis and Treatment of the National Cancer Institute (NCI), invites applications for new or competing P50 research center grants for In Vivo Cellular and Molecular Imaging Centers (ICMICs). This initiative is designed to capitalize on the extraordinary opportunity for molecular imaging to have an impact on the diagnosis and treatment of cancer patients noninvasively and quantitatively. Molecular imaging technologies can provide valuable laboratory tools for the interrogation of biological pathways relevant to cancer, as well as to provide imaging agents and technologies that will be directly utilized in the clinic.

The 5-year P50 ICMIC grants described in this program announcement (PAR) are designed to bring together interdisciplinary scientific teams to lead the nation in cutting-edge cancer molecular imaging research with clinical relevance, provide unique core facilities to support oncology imaging research, provide flexibility to respond to exciting pilot research opportunities, and provide interdisciplinary career development opportunities for investigators new to the field of molecular cancer imaging. The P50 mechanism will promote coordination, interrelationships, and scientific synergy among the research components and resources, leading to a highly integrated imaging center.

The field of molecular imaging has made significant advances in recent years. The formation of multidisciplinary research teams has stimulated and streamlined cancer imaging research from inception to use in patient care. The P50 ICMIC structure allows mechanistic flexibility for each institution to capitalize on its own unique scientific strengths, and to define the structure and research objectives that create the most synergistic and creative scientific interactions. In general, an ICMIC will provide researchers with the following critical resources, as described below:

The ICMICs will provide an organizational structure specifically designed to facilitate multidisciplinary interactions among investigators focused on the ultimate goal of discovering, developing, and translating molecular imaging technologies that will have eventual impact in the clinic. This structure will provide researchers with access to a concentrated pool of expertise in a wide range of disciplines. The structure of the ICMIC will be designed to provide investigators with the means to conduct multidisciplinary research in a highly collaborative atmosphere; investigators will also have consistent access to expertise, with minimal wasted time and effort. Personnel may be scientists from a variety of fields including, but not limited to, imaging sciences, chemistry, radiopharmaceutical chemistry, cell and molecular biology, pathology, pharmacology, computational sciences, and biomedical engineering. Other specialists in fields such as MRI physics, immunology, or neuroscience, for example, may also be involved. Most importantly, ICMIC personnel must demonstrate an eagerness to collaborate outside of their own disciplines. The nature of these interactions will be determined by the applicants, and emphasis will be placed on establishing creative, productive, and synergistic interactions with eventual clinical impact.

The ICMICs will provide funding for a minimum of three research components. Research components will apply multidisciplinary approaches to molecular imaging. Individual research projects will be structured in order to maximize appropriate scientific interaction between the projects and coordinated utilization of the center's specialized resources as described below. Each research component will be similar in size and scope to a typical R01 or subproject of a P01, and will be expected to meet the same standards of preliminary data in support of the hypotheses.

The ICMICs will provide specialized resource facilities and services. A barrier to productive scientific interaction is the lack of available facilities for cross-disciplinary experiments. Demands on equipment, resources, and reagents in every scientific area are extremely high, and these demands prohibit ready access for investigators interested in expanding their studies into new areas of research. The establishment of specialized resources dedicated to ICMIC-related research will provide this access. The specialized resource(s) will be determined by the requirements of the institution, the defined scientific goals of the research components of the ICMIC, and budgetary limits. Prioritization of the research projects supported through ICMIC specialized resources will be an essential function of the ICMIC's leadership, and the mechanism to be employed for prioritization must be delineated by the applicants. Resource facilities may be utilized by active members of the ICMIC and will also be available to investigators supported through developmental funds.

ICMICs will provide developmental funds for feasibility testing of new projects. A high priority of each ICMIC will be the identification and support of pilot projects that identify and stimulate interdisciplinary projects that will take full advantage of emerging research opportunities. The selection of projects will be through a review process established by the ICMIC's leadership.

The portfolio of ongoing projects in any given program is expected to be extremely dynamic. This fund is nor to be used to support traditional, ongoing projects that could readily be supported through R01s. It is not appropriate to use for projects that utilize single areas of expertise or to support the continuation of previously funded research projects, and developmental projects may not be supported for more than 2 years. Necessary equipment should be provided through the appropriate specialized resource. These projects are to be monitored closely by the ICMIC leadership. Investigators working on projects supported through the development fund must understand that they will be expected to compete for independent R01 funding when the projects become sufficiently mature. Alternately, if it becomes obvious that the project will not provide the expected results, a plan should be in place for terminating a development project.

ICMICs will provide career development opportunities for new and established investigators. Current graduate programs are generally focused on single disciplines and may be inadequate to train the needed cadre of interdisciplinary imaging scientists. The ICMICs will provide support for a limited number of pre- and postdoctoral trainees in a program to be defined by the applicants. Career development opportunities through the ICMIC will be expected to be highly cross-disciplinary.

This PAR will use the NIH P50 Specialized Centers Grant mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for a P50 application submitted in response to this PAR may not exceed 5 years. The total costs requested for a new or competing renewal P50 ICMIC application may not exceed a maximum of $2 million per year. The NCI anticipates awarding 2 new or competing P50 ICMICs each year.

This PAR uses just-in-time concepts. It also uses the nonmodular budgeting formats. Follow the instructions for nonmodular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/ nihgps_2003/NIHGPS_Part2.htm.

ICMIC investigators will be expected to participate in ICMIC workshops and investigator meetings as necessary to share results with other ICMICs, share materials, assess progress, identify new research opportunities, and establish interactions and research priorities and collaborations. Travel funds for the principal investigator and selected ICMIC investigators and collaborators may be budgeted for this purpose.

For those projects that involve clinical trials, investigators must include a general description of the data and safety monitoring plan (for details, see http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-00-038.html) in the application, All clinical trials supported or performed by NIH require some form of monitoring. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NIH program staff to a data and safety monitoring board. These monitoring activities are distinct from the requirement for study review and approval by an institutional review board. For further details about the policy of the data and safety monitoring of clinical trials, see http://deainfo.nci.nih.gov/grantspolicies/ datasafety.htm.

All investigator-initiated applications with direct costs greater than $500,000 in any single year will be expected to address data sharing (see http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-03-032.html) in their application.

Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applications must have a Dun and Bradstreet Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for federal grants or cooperative agreements. The DUNS number can be obtained by calling 1-866-705-5711 or through the website at http:// www.dunandbradstreet.com/. The PHS 398 document is available at http://grants.nih.gov/grants/ funding/phs398/phs398.html in an interactive format. For further assistance, contact GrantsInfo, 301-435-0714, e-mail: [e-mail].

Letters of intent are due 22 June 2004 or 21 June 2005, with applications due 22 July 2004 or 21 July 2005. For more information, see http://grants. nih.gov/grants/guide/pa-files/PAR-04-069.html.

Contact: Direct questions about scientific and research issues to Anne E. Menkens, Cancer Imaging Program, NCI, 6130 Executive Blvd, EPN Rm 6068, Bethesda, MD 20892-8329 USA, 301-496-9531, fax: [phone], e-mail: am187k@ nih.gov; direct questions about peer review issues to the Referral Officer, Division of Extramural Activities, NCI, 6116 Executive Blvd, Rm 8041, MSC 8329, Bethesda, MD 20892-8329 USA, 301-496-3428, fax: [phone], e-mail: [e-mail]; direct questions about financial and grants management matters to Kathryn Dunn, Grants Management Specialist, Grants Administration Branch, NCI, 6120 Executive Blvd, EPS Rm 243, Bethesda, MD 20892 USA, 301-846-6829, fax: [phone], e-mail: [e-mail]. Reference: PA No. PAR-04-069