Summary: The National Cancer Institute (NCI) is seeking Collaborators for Cooperative Research and Development Agreements (CRADA) to work with investigators in the Radiation Oncology Sciences Program (ROSP) towards the development of a dynamic ROMAT Center that links imaging, radiation therapy and systemic therapy to underlying molecular processes. The overall goals are to understand the biological changes that produce the various images (MR, CT, PET, optical, others to be developed, etc.) along with existing and novel imaging and contrast agents, to inter-compare imaging modalities, and to assess the changes in image and molecular signature that occur during and after cancer treatment. The NCI is seeking long-term dynamic and highly interactive scientific collaborations with parties developing current and future technology for molecular imaging in clinical and preclinical settings. The intention is to create an environment that will link a spectrum of clinicians, basic scientists, engineers, physicists, chemists, and extramural collaborators to facilitate the delivery of molecular imaging and therapy to patients. Potential Areas of Application: - Various imaging modalities and techniques can be compared with one another and related to the underlying biological processes. - Novel imaging technologies and applications can be rapidly compared with existing technology, thereby expediting development. - The impact of intervention with radiation and/or systemic agents can be evaluated in the image and molecular biological changes. - Animal and human imaging can be intercompared. - Development of novel supporting technologies such as robotics and image processing, etc. Main Advantages of Technology/Intervention: The NCI offers the opportunity to partner in establishing the ROMAT Center which will provide the locus and environment for the conduct of clinical and preclinical studies designed to improve cancer diagnosis and treatment. ROMAT will use imaging and molecular analyses such as genomics and proteomics that ultimately may allow for the individualization of cancer prevention and treatment. The ROMAT program will advance the clinical application of new imaging and therapeutic strategies through comprehensive patient study in a clinical research environment. ROMAT is designed to enhance collaboration among NCI, industry and academic partners, utilizing the unique resources available in the NIH Clinical Center. To optimize newly emerging technologies and to expedite their rapid application to clinical medicine, there is the need to be able to study novel approaches in an environment that brings together the appropriate breadth of expertise. The goal of this translational research program is to facilitate the application of new technology and biology to the care of patients. Current state of development: ROSP Attributes: - Developed the clinical use of closed bore (high field, 1.5T) MR-guided High Dose Radiation (HDR) brachytherapy. - Radiation Therapy-Intensity Modulated Radiation Therapy (IMRT) being implemented and stereotatic radiotherapy available. - Genomics (microarray) capabilities through the Advanced Technology Center (ATC), Center for Cancer Research (CCR), NCI. - Strength in the field of proteomics. - Expertise in chemistry for antibody therapy and new imaging agents. - The Radiation Biology Branch (component of ROSP) is developing electron-paramagnetic resonance (EPR) and Overhauser enhanced MRI (OMRI) to image hypoxia and other biochemical processes. - Interactive relationship with the CCR which includes the joint effort to implement the Advanced Tumor Imaging Program (ATIP). - On-going collaborations with the NIH Clinical Center (CC) for intraoperative MR brachytherapy and surgery (being implemented) and other imaging studies. - Preclinical models for animal imaging. - Access to the NIH Mouse Imaging Facility (MIF). - Interaction with the Molecular Radiation Therapeutics Branch, Division of Cancer Treatment and Diagnosis (DCTD) for developing novel radiation sensitizers and protectors. - Clinical trials infrastructure. - Patient care resources. - A highly collaborative environment with the opportunity and need for industrial partners to provide both technology and expertise. Further R & D Required: - Acquisition and maintenance of state-of-the-art 3T MR technology and ongoing optimization of imaging sequences, including contrast agents. - Acquisition and maintenance of state-of-the-art CT-PET. - Acquisition and maintenance of state-of-the-art radiation therapy external beam treatment technology. - Establishment of techniques for image fusion using all modalities and utilizing such information for radiation treatment planning. - Introduction into pre-clinical and clinical trials of novel technologies, e.g., optical, ultrasound with contrast agents, EPR/OMRI and others to be developed. Collaborator Contribution sought: - A Collaborator will use its technological expertise, development capability, and hardware resources to collaborate in this venture. - A Collaborator will provide on-site expertise to serve as partners and co-investigators. This may help the Collaborator provide sabbatical time for their staff. - A dynamic relationship is optimal so that the appropriate state-of-the-art technology is available as the goal is to optimize the modality. This will require updating as deemed appropriate and necessary. - Innovation and creativity and an interest in merging technology with biology. - Creativity in resource allocation and sharing to optimize the ability of the Collaborator and NCI to provide to the project what each can do best. Proposed NCI Contribution: The role of the NCI in the CRADA may include, but is not limited to: - Physician expertise: radiation, medical, surgical and pediatric oncology, immunology, neurooncology, pathology, and others. - Expertise in diagnostic imaging. - Medical physics and computer expertise. - Radiation therapy equipment including linear accelerators, HDR, intraoperative MR guided brachytherapy, treatment planning. - Radiation biology expertise and systems from molecular targeted therapy to preclinical development to clinical trial support. - Basic science support. - Access to genomic and proteomic expertise. - Access to novel therapeutic agents and to chemists for molecule design. - Patient care resources. - Telemedicine expertise. Proposed Joint Contribution: NCI and a Collaborator will jointly design a CRADA Research Plan and will jointly interpret the data generated under the Research Plan. Selection Criteria for Choosing a CRADA Collaborator May Include: 1. A demonstrated background and expertise in imaging, including molecular imaging. 2. A demonstrated record of success in the commercial development and production of products. 3. The demonstration of adequate resources (e.g. facilities, personnel, expertise) to assist in this venture and to perform the research and development necessary for commercialization of the resulting inventions. 4. The willingness and ability to accomplish objectives according to an appropriate timetable to be outlined in the CRADA proposal. 5. The willingness to commit best effort and demonstrated resources to the research and development programs. 6. The willingness to be creative in science, technology and mechanisms of collaboration with the purpose of accelerating discovery and technological applications to the care of people with or at risk of cancer. 7. The ability to provide financial support and/or equipment for CRADA-related activities. 8. The ability to provide staff and/or staffing support for CRADA-related activities 9. The willingness to cooperate with the NCI in the timely publication of research results. 10. The agreement to be bound by the appropriate Department of Health and Human Services (DHHS) regulations relating to human subject research and to all Public Health Service (PHS) policies relating to the use and care of laboratory animals. 11. The willingness to accept the legal provisions and language of the CRADA. These provisions govern the distribution of future patent rights to CRADA inventions. Generally, the rights of ownership are retained by the organization that is the employer of the inventor with (1) the grant of a license for research and other Government purposes to the Government when the CRADA Collaborator's employee is the sole inventor, or (2) the grant of an option to elect an exclusive or nonexclusive license to the CRADA Collaborator when the Government employee is the sole inventor. Response Procedure: Interested parties should submit a written scientific proposal which includes discussion of the selection criteria to the Technology Transfer Branch of the NCI no later than Friday, July 25, 2003. Proposals submitted thereafter may be considered if suitable CRADA Collaborators are not selected from among the timely responses.
