Advancing Nuclear Medicine Through Innovation

Committee on State of the Science of Nuclear Medicine

Nuclear and Radiation Studies Board

Division of Earth and Life Studies

Board on Health Sciences Policy

Institute of Medicine

NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C. www.nap.edu



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Advancing Nuclear Medicine through Innovation Advancing Nuclear Medicine Through Innovation Committee on State of the Science of Nuclear Medicine Nuclear and Radiation Studies Board Division of Earth and Life Studies Board on Health Sciences Policy Institute of Medicine NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Advancing Nuclear Medicine through Innovation THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance. This study was supported by Contract No. DE-AM01-04PI45013, Task Order DE-AT01-06ER64218 between the National Academy of Sciences and the U.S. Department of Energy and Contract No. N01-OD-4-2139 between the National Academy of Sciences and the U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number-13: 978-0-309-11067-9 (Book) International Standard Book Number-10: 0-309-11067-X (Book) International Standard Book Number-13: 978-0-309-11068-6 (PDF) International Standard Book Number-10: 0-309-11068-8 (PDF) Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Cover: Photo courtesy of Peter Conti, University of Southern California. Copyright 2007 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.

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Advancing Nuclear Medicine through Innovation THE NATIONAL ACADEMIES Advisers to the Nation on Science, Engineering, and Medicine The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering. The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine. The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Advancing Nuclear Medicine through Innovation COMMITTEE ON STATE OF THE SCIENCE OF NUCLEAR MEDICINE HEDVIG HRICAK (Chair), Memorial Sloan-Kettering Cancer Center, New York S. JAMES ADELSTEIN, Harvard Medical School, Boston, Massachusetts PETER S. CONTI, University of Southern California, Los Angeles JOANNA FOWLER, Brookhaven National Laboratory, Upton, New York JOE GRAY, Lawrence Berkeley National Laboratory, Berkeley, California LIN-WEN HU, Massachusetts Institute of Technology, Cambridge JOEL KARP, University of Pennsylvania, Philadelphia THOMAS LEWELLEN, University of Washington, Seattle ROGER MACKLIS, Cleveland Clinic Foundation, Ohio C. DOUGLAS MAYNARD, Wake Forest University School of Medicine, Winston-Salem, North Carolina THOMAS J. RUTH, Tri-University Meson Facility, Vancouver, Canada HEINRICH SCHELBERT, University of California, Los Angeles GUSTAV VON SCHULTHESS, University Hospital of Zurich, Switzerland MICHAEL R. ZALUTSKY, Duke University, Durham, North Carolina Staff NAOKO ISHIBE, Study Director MARILYN FIELD, Senior Program Officer TRACEY BONNER, Program Assistant SHAUNTEÉ WHETSTONE, Program Assistant

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Advancing Nuclear Medicine through Innovation NUCLEAR AND RADIATION STUDIES BOARD RICHARD A. MESERVE (Chair), Carnegie Institution, Washington, D.C. S. JAMES ADELSTEIN (Vice Chair), Harvard Medical School, Boston, Massachusetts JOEL S. BEDFORD, Colorado State University, Fort Collins SUE B. CLARK, Washington State University, Pullman ALLEN G. CROFF, Oak Ridge National Laboratory (retired), St. Augustine, Florida DAVID E. DANIEL, University of Texas at Dallas SARAH C. DARBY, Clinical Trial Service Unit, Oxford, United Kingdom ROGER L. HAGENGRUBER, University of New Mexico, Albuquerque DANIEL KREWSKI, University of Ottawa, Ontario, Canada KLAUS KÜHN, Technische Universität Clausthal, Clausthal-Zellerfeld, Germany MILTON LEVENSON, Bechtel International (retired), Menlo Park, California C. CLIFTON LING, Memorial Hospital, New York, New York PAUL A. LOCKE, Johns Hopkins University, Baltimore, Maryland WARREN F. MILLER, Texas A & M University, College Station ANDREW M. SESSLER, Lawrence Berkeley National Laboratory, Berkeley, California JOHN C. VILLFORTH, Food and Drug Law Institute (retired), Derwood, Maryland PAUL L. ZIEMER, Purdue University (retired), West Lafayette, Indiana Staff KEVIN D. CROWLEY, Director EVAN B. DOUPLE, Scholar RICK JOSTES, Senior Program Officer MICAH D. LOWENTHAL, Senior Program Officer JOHN R. WILEY, Senior Program Officer NAOKO ISHIBE, Program Officer TONI GREENLEAF, Financial and Administrative Associate LAURA D. LLANOS, Financial and Administrative Associate COURTNEY GIBBS, Senior Program Assistant MANDI BOYKIN, Program Assistant SHAUNTEÉ WHETSTONE, Program Assistant JAMES YATES, JR., Office Assistant

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Advancing Nuclear Medicine through Innovation BOARD ON HEALTH SCIENCES POLICY FRED H. GAGE (Chair), The Salk Institute for Biological Studies, La Jolla, California C. THOMAS CASKEY, University of Texas—Houston Health Science Center GAIL H. CASSELL, Eli Lilly and Company, Indianapolis, Indiana JAMES F. CHILDRESS, University of Virginia, Charlottesville ELLEN WRIGHT CLAYTON, Vanderbilt University Medical School, Nashville, Tennessee LINDA C. GIUDICE, University of California, San Francisco LYNN R. GOLDMAN, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland LAWRENCE O. GOSTIN, Georgetown University Law Center, Washington, D.C. MARTHA N. HILL, Johns Hopkins University School of Nursing, Baltimore, Maryland ALAN LESHNER, American Association for the Advancement of Science, Washington, D.C. DAVID KORN, Association of American Medical Colleges, Washington, D.C. JONATHAN D. MORENO, University of Pennsylvania, Philadelphia E. ALBERT REECE, University of Maryland School of Medicine, Baltimore LINDA ROSENSTOCK, University of California, Los Angeles MICHAEL J. WELCH, Washington University School of Medicine, St. Louis, Missouri OWEN N. WITTE, University of California, Los Angeles IOM Staff ANDREW M. POPE, Director AMY HAAS, Board Assistant GARY WALKER, Senior Financial Officer

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Advancing Nuclear Medicine through Innovation Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards of objectivity, evidence, and responsiveness to the study charge. The content of the review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their participation in the review of this report: Simon Cherry, University of California, Davis Chaitanya Divgi, University of Pennsylvania, Philadelphia Ora Israel, Rambam Medical Center, Haifa, Israel Jeanne Link, University of Washington, Seattle Michael Phelps, University of California, Los Angeles Theodore Phillips, University of California, San Francisco Donald Podoloff, M.D. Anderson Cancer Center, Houston, Texas Richard Reba, Georgetown University, Washington, D.C. Kirby Vosburgh, Center for Integration of Medicine and Innovative Technologies, Cambridge, Massachusetts Michael Welch, Washington University, St. Louis, Missouri

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Advancing Nuclear Medicine through Innovation Chris Whipple, ENVIRON International Corporation, Emeryville, California Paul Ziemer, Purdue University, West Lafayette, Indiana Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the report’s conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Floyd Bloom, Professor Emeritus, The Scripps Research Institute, and John Ahearne, Manager of the Ethics Program, Sigma Xi, The Scientific Research Society. Appointed by the National Research Council. They were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the National Research Council.

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Advancing Nuclear Medicine through Innovation Preface It has been an honor and a privilege to chair the committee on the state of science in nuclear medicine. As a diagnostic radiologist, a clinician-scientist, and the chairperson of a large academic radiology department, I have been exposed to the many advances in nuclear medicine and have observed their clinical benefits up close. Participating in this review, however, has allowed me to step back and appreciate the magnitude of the progress that has been achieved, and the crucial role that government funding has played in it. Investments in chemistry, physics, engineering, and training are responsible for the state-of-the-art radiopharmaceuticals and imaging instruments that we now rely on to improve our understanding of human physiology through non-invasive disease detection and treatment monitoring. These advances have already had a major impact on all branches of imaging and medicine, yet, they pale in comparison to those on the horizon. Nuclear medicine offers a unique, non-invasive view into intracellular processes and enzyme trafficking, receptors and gene expression, and forms the theoretical and applied foundation for molecular medicine. The contributions of nuclear medicine are creating the possibility of a future of personalized medicine, in which treatments and medications will be based on an individual’s unique genetic profile and response to disease processes. Although the progress in nuclear medicine research in the United States has been spectacular, potential obstacles to its continuation have been noted in previous reports, including a critical shortage of chemists and other personnel trained in nuclear medicine, and an inadequate supply of

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Advancing Nuclear Medicine through Innovation radionuclides for research and development. In addition, uncertainty has arisen about how, and to what degree, the government should continue to fund nuclear medicine research. For years, the basic chemistry and physics research behind the growth of the field has been supported by the Medical Applications and Sciences Program of the Department of Energy (DOE) Office of Biological and Environmental Research. However, the uniqueness of this program relative to the nuclear medicine research funded by the National Institutes of Health (NIH) has long been under debate. The DOE and the NIH commissioned this study on the state of the science in nuclear medicine because of the uncertainty surrounding the support of the Medical Applications and Sciences Program. Specifically, the sponsoring agencies asked that the National Academies assess areas of need in nuclear medicine research, examine the program and make recommendations to improve its impact on nuclear medicine research and isotope production. In response to this request, the National Research Council of the National Academies appointed a committee of 14 experts to carry out this study. The committee gathered information from members of the public, experts on nuclear medicine, scientific and medical societies, and federal agencies. In composing its report, the committee decided to describe the needs in nuclear medicine research primarily in terms of future opportunities in the field. Thus the report, in my view, is an exciting, forward-looking document that makes clear the potential of the field for further advancing medicine, and suggests practical steps to facilitate progress. I hope and believe that it will have a positive impact on the future of nuclear medicine. Hedvig Hricak, Chair

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Advancing Nuclear Medicine through Innovation Acknowledgments The committee is grateful to the speakers and panelists (listed in Appendix A) who participated in the information-gathering sessions for the study. In addition, the committee wishes to thank Belinda Seto, Peter Preusch, and Dan Sullivan at the National Institutes of Health (NIH); and Mike Viola, John Pantaleo, Prem Srivastava, and Peter Kirschner at the Department of Energy (DOE) for contributing their time, efforts, and insights to the study. I would like to personally thank my fellow committee members for their dedication to carrying out a thorough study and writing a useful report. They all cared deeply about the topic, and their probing questions and lively discussions ensured that we covered a wide range of issues and considered them from multiple angles. Studies such as this are often long on information and short on time, and the committee would like to thank the many National Research Council staff members whose help was essential in producing this report. Among these, the committee particularly wishes to acknowledge Kevin Crowley, Director of the Nuclear and Radiation Studies Board, for providing guidance on the study process and keeping the committee focused on its charge; Shaunteé Whetstone and James Yates for their administrative support; Toni Greenleaf for making sure that we stayed on budget; and Rick Jostes for his technical contributions to the report. I would especially like to thank the

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Advancing Nuclear Medicine through Innovation Study Director, Naoko Ishibe, for her devotion to the project, and particularly for her superb work in coordinating the writing of the report. Finally, I am grateful to the DOE and NIH for sponsoring this study. Hedvig Hricak, Chair

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Advancing Nuclear Medicine through Innovation Contents     SUMMARY   1 1   INTRODUCTION   10      Strategy to Address the Study Charge,   14      Report Roadmap,   15 2   NUCLEAR MEDICINE   17      Significant Discoveries,   22      Frontiers in Nuclear Medicine,   23      Complexities of Nuclear Medicine Practice and Research,   38      Conclusion,   42 3   NUCLEAR MEDICINE IMAGING IN DIAGNOSIS AND TREATMENT   43      Background,   43      Current State of Nuclear Medicine Imaging and Emerging Priorities,   44      Impediments to Progress and Current and Future Needs,   56 4   TARGETED RADIONUCLIDE THERAPY   59      Background,   60      Significant Discoveries,   65      Current State of the Field and Emerging Priorities,   66      Current Impediments to Full Implementation of Targeted Radiopharmaceutical Therapeutics,   72

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Advancing Nuclear Medicine through Innovation      Recommendations,   73      Conclusions,   74 5   AVAILABILITY OF RADIONUCLIDES FOR NUCLEAR MEDICINE RESEARCH   75      Background,   75      Significant Discoveries,   76      Current State of Radionuclide Availability in the United States,   80      Current and Future Needs,   83      Recommendations,   87 6   RADIOTRACER AND RADIOPHARMACEUTICAL CHEMISTRY   89      Background,   89      Significant Discoveries,   90      Current State of the Field and Emerging Priorities,   93      Current Needs and Impediments,   101      Recommendations,   102 7   INSTRUMENTATION AND COMPUTATIONAL SCIENCES   104      Background,   104      Significant Discoveries,   107      Current State of the Field and Emerging Priorities,   111      Future Needs,   114      Findings,   116      Recommendations,   117 8   EDUCATION AND TRAINING OF NUCLEAR MEDICINE PERSONNEL   118      Background,   118      Current Status of the Workforce,   119      Findings,   129      Recommendations,   130     REFERENCES   131     APPENDIXES     A   INFORMATION-GATHERING SESSIONS   141 B   GLOSSARY AND ACRONYMS   146 C   COMMERCIALLY AVAILABLE RADIOPHARMACEUTICALS   151 D   BIOGRAPHICAL SKETCHES OF COMMITTEE MEMBERS   155