National Cancer Institute - NCI Division of Cancer Treatment and ...
National Cancer Institute - NCI Division of Cancer Treatment and ... National Cancer Institute - NCI Division of Cancer Treatment and ...
General Electric Healthcare http://www.gehealthcare.com/ usen/index.html NCI, through CIP, has entered into an agreement with General Electric Healthcare to develop the radiopharmaceutical imaging agent F-18 fluorodeoxythymidine for use with positron emission tomography (PET) in clinical trials. This agreement may serve as a template for similar projects. NCI and FDA are also working together to evaluate other approaches to implementing regulatory requirements governing the use of imaging agents. National Institute of Biomedical Imaging and Bioengineering and the Radiological Society of North America http://www.nibib.nih.gov/publicPage. cfm?pageID=639 http://www.rsna.org/ CIP is collaborating with the Radiological Society of North America (RSNA), the NCI Center for Bioinformatics, and the National Institute of Biomedical Imaging and Bioengineering (NIBIB) on a pilot project called the Reference Image Database to Evaluate Response to Therapy in Lung Cancer (RIDER). RIDER, which is part of the larger LIDC initiative (http://imaging.cancer.gov/ reportsandpublications/Reportsand Presentations/LungImaging), aims to produce a reference database for researchers, allowing them to develop software and other tools to address the problems of cancer detection, characterization, and response to therapy. This collaborative effort is reducing barriers to research by generating publicly available image databases, with the first prototypes being related to the imaging of lung cancer. The RIDER pilot project thus far has resulted in an initial Web-accessible resource (http://imaging.nci.nih.gov/i3/) of serial CT data compatible with the NCI Cancer Biomedical Informatics Grid (caBIG). The proposed expansion of the RIDER project will initially include image and related metadata collected from imaging modalities such as X-ray CT and PET/CT as applied to lung cancer, collected from a wide range of both NCI- and industry-supported drug trials. One important industry goal of this resource is to attempt to accelerate FDA approval and the Centers for Medicare & Medicaid Services (CMS) reimbursement of software tools. RIDER is striving to accomplish all its goals using open-source coding so that researchers can tailor applications to meet their individual specifications and mesh with other applications. C A N C E R I M A G I N G P R O G R A M ■ 59
Food and Drug Administration and Centers for Medicare & Medicaid Services http://www.fda.gov http://www.cms.hhs.gov The National Forum on Biomedical Imaging in Oncology (NFBIO) was created in 1999 to facilitate partnerships between researchers, the imaging industry, and government agencies. The goal is to address new biomedical opportunities and challenges in oncology and to focus on the regulatory, coverage, and reimbursement issues for established technologies to improve patient diagnosis and care. The forums are cosponsored by NCI, the National Electrical Manufacturers Association (NEMA), FDA, and CMS. The sixth NFBIO took place April 7–8, 2005, and focused on quantitative oncologic imaging. The speakers’ presentations and other information are available on the NFBIO Website: http://imaging.cancer.gov/ NewsAndMeetings/meetings. Some Technologies Presented to the Interagency Council on Biomedical Imaging in Oncology in the Pas 1. Computed tomography (CT) and combination instrumentation 2. Magnetic resonance imaging (MRI)/magnetic resonance spectroscopy (MRS)—various instrument strengths from 1.5 to 12 Tesla 3. Ultrasound 4. Optical imaging 5. Nuclear medicine, both single-photon and positron emission tomography 6. Molecular imaging agents 7. Image-guided therapy 60 ■ P R O G R A M A C C O M P L I S H M E N T S 2 0 0 6 The Interagency Council on Biomedical Imaging in Oncology (ICBIO), with its next meeting set for October 17, 2006, brings representatives of NCI, FDA, and CMS together with technology developers to expedite the launch of new imaging products. The council’s representatives provide advice on the spectrum of scientific, regulatory, and reimbursement issues related to developing an imaging device or technology. Any business or academic investigator who develops a technology relevant to biomedical imaging in cancer may submit a request. Investigators typically meet with the council for approximately one hour for an informal and confidential discussion. More information is available on the council’s Website: http://imaging. cancer.gov/programsandresources/ specializedinitiatives/ICBIO. CIP and FDA have an interagency agreement to develop databases for evaluating image-processing methods for cancer screening, diagnosis, and treatment. The collaboration seeks to develop: ■ Criteria to design and populate proposed image databases for the evaluation of computer-aided diagnosis and related processing methods ■ Statistical methods to determine the size and content of the proposed image databases and permit the comparison of image processing or computer-aided diagnosis methods ■ Statistical methodology for evaluating performance of computer-aided diagnosis and image-processing methods
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Food <strong>and</strong> Drug Administration<br />
<strong>and</strong> Centers for Medicare &<br />
Medicaid Services<br />
http://www.fda.gov<br />
http://www.cms.hhs.gov<br />
The <strong>National</strong> Forum on Biomedical Imaging<br />
in Oncology (NFBIO) was created in<br />
1999 to facilitate partnerships between<br />
researchers, the imaging industry, <strong>and</strong><br />
government agencies. The goal is to<br />
address new biomedical opportunities<br />
<strong>and</strong> challenges in oncology <strong>and</strong> to<br />
focus on the regulatory, coverage, <strong>and</strong><br />
reimbursement issues for established<br />
technologies to improve patient diagnosis<br />
<strong>and</strong> care. The forums are cosponsored by<br />
<strong>NCI</strong>, the <strong>National</strong> Electrical Manufacturers<br />
Association (NEMA), FDA, <strong>and</strong> CMS. The<br />
sixth NFBIO took place April 7–8, 2005, <strong>and</strong><br />
focused on quantitative oncologic imaging.<br />
The speakers’ presentations <strong>and</strong> other<br />
information are available on the NFBIO<br />
Website: http://imaging.cancer.gov/<br />
NewsAndMeetings/meetings.<br />
Some Technologies Presented to the Interagency<br />
Council on Biomedical Imaging in Oncology in the Pas<br />
1. Computed tomography (CT) <strong>and</strong> combination instrumentation<br />
2. Magnetic resonance imaging (MRI)/magnetic resonance spectroscopy<br />
(MRS)—various instrument strengths from 1.5 to 12 Tesla<br />
3. Ultrasound<br />
4. Optical imaging<br />
5. Nuclear medicine, both single-photon <strong>and</strong> positron emission<br />
tomography<br />
6. Molecular imaging agents<br />
7. Image-guided therapy<br />
60 ■ P R O G R A M A C C O M P L I S H M E N T S 2 0 0 6<br />
The Interagency Council on Biomedical<br />
Imaging in Oncology (ICBIO), with its next<br />
meeting set for October 17, 2006, brings<br />
representatives <strong>of</strong> <strong>NCI</strong>, FDA, <strong>and</strong> CMS<br />
together with technology developers to<br />
expedite the launch <strong>of</strong> new imaging products.<br />
The council’s representatives provide<br />
advice on the spectrum <strong>of</strong> scientific, regulatory,<br />
<strong>and</strong> reimbursement issues related<br />
to developing an imaging device or technology.<br />
Any business or academic investigator<br />
who develops a technology relevant<br />
to biomedical imaging in cancer may<br />
submit a request. Investigators typically<br />
meet with the council for approximately<br />
one hour for an informal <strong>and</strong> confidential<br />
discussion. More information is available<br />
on the council’s Website: http://imaging.<br />
cancer.gov/programs<strong>and</strong>resources/<br />
specializedinitiatives/ICBIO.<br />
CIP <strong>and</strong> FDA have an interagency agreement<br />
to develop databases for evaluating<br />
image-processing methods for cancer<br />
screening, diagnosis, <strong>and</strong> treatment. The<br />
collaboration seeks to develop:<br />
■ Criteria to design <strong>and</strong> populate proposed<br />
image databases for the evaluation<br />
<strong>of</strong> computer-aided diagnosis <strong>and</strong><br />
related processing methods<br />
■ Statistical methods to determine the<br />
size <strong>and</strong> content <strong>of</strong> the proposed image<br />
databases <strong>and</strong> permit the comparison<br />
<strong>of</strong> image processing or computer-aided<br />
diagnosis methods<br />
■ Statistical methodology for evaluating<br />
performance <strong>of</strong> computer-aided diagnosis<br />
<strong>and</strong> image-processing methods
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