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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
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 Govern-
ing Board of the National Research Council, whose members are drawn from the
councils of the National Academy of Sciences, the National Academy of Engineer-
ing, and the Institute of Medicine. The members of the committee responsible for
the report were chosen for their special competences and with regard for appropri-
ate 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 organiza-
tions 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.

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 Acad-
emy 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 en-
gineers. 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 engineer-
ing programs aimed at meeting national needs, encourages education and research,
and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi-
dent 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 Insti-
tute 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 Sci-
ences 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 Coun-
cil 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
 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

iv
 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


 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

vi
 Reviewers

T
his 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

vii
viii REVIEWERS

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 con-
clusions 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 car-
ried 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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 Preface

I
t 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 depart-
ment, 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 pro-
cesses and enzyme trafficking, receptors and gene expression, and forms the
theoretical and applied foundation for molecular medicine. The contribu-
tions of nuclear medicine are creating the possibility of a future of person-
alized 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

ix
 PREFACE

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 Medi-
cal 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 Na-
tional Academies appointed a committee of 14 experts to carry out this
study. The committee gathered information from members of the public, ex-
perts on nuclear medicine, scientific and medical societies, and federal agen-
cies. 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

 Acknowledgments

T
he committee is grateful to the speakers and panelists (listed in Ap-
pendix 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 Coun-
cil 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 guid-
ance 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

xi
xii ACKNOWLEDGMENTS

Study Director, Naoko Ishibe, for her devotion to the project, and particu-
larly 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

 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

xiii
xiv CONTENTS

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
 Summary

T
he history of nuclear medicine over the past 50 years reflects the
strong link between government investments in science and technol-
ogy and advances in health care in the United States and worldwide.
As a result of these investments, new nuclear medicine procedures have
been developed that can diagnose diseases non-invasively, providing in-
formation that cannot be acquired with other imaging technologies; and
deliver targeted treatments. Nearly 20 million nuclear medicine proce-
dures using radiopharmaceuticals and imaging instruments are carried out
annually in the United States alone. Overall usage of nuclear medicine
procedures is expanding rapidly, especially as new imaging technologies,
such as positron emission tomography/computed tomography (PET/CT)
and single photon emission computed tomography/computed tomography
(SPECT/CT), continue to improve the accuracy of detection, localization,
and characterization of disease, and as automation and miniaturization of
cyclotrons and advances in radiochemistry make production of radiotracers
more practical and versatile.
Recent advances in the life sciences (e.g., molecular biology, genetics,
and proteomics) have stimulated development of better strategies for de-
tecting and treating disease based on an individual’s unique profile, an ap-
proach that is called “personalized medicine.” The growth of personalized
medicine will be aided by research that provides a better understanding of
normal and pathological processes; greater knowledge of the mechanisms

 Proteomics is the study of the structure and function of proteins, including the way they
interact with each other in cells.


 ADVANCING NUCLEAR MEDICINE THROUGH INNOVATION

by which individual diseases arise; superior identification of disease sub-

types; and better prediction of an individual patient’s responses to treat-
ment. However, the process of advancing patient care is complex and slow.
Expanded use of nuclear medicine techniques has the potential to accelerate,
simplify, and reduce the costs of developing and delivering improved health
care and could facilitate the implementation of personalized medicine.
Current clinical applications of nuclear medicine include the ability
to:

• diagnose diseases such as cancer, neurological disorders (e.g., Al-

zheimer’s and Parkinson’s diseases), and cardiovascular disease in their
initial stages, permitting earlier initiation of treatment as well as reduced
morbidity and mortality;
• non-invasively assess therapeutic response, reducing patients’ ex-
posure to the toxicity of ineffective treatments and allowing alternative
treatments to be started earlier; and
• provide molecularly targeted treatment of cancer and certain endo-
crine disorders (e.g., thyroid disease and neuroendocrine tumors).

Emerging opportunities in nuclear medicine include the ability to:

• understand the relationship between brain chemistry and behavior

(e.g., addictive behavior, eating disorders, depression);
• assess the atherosclerotic cardiovascular system;
• understand the metabolism and pharmacology of new drugs;
• assess the efficacy of new drugs and other forms of treatments,
speeding their introduction into clinical practice;
• employ targeted radionuclide therapeutics to individualize treat-
ment for cancer patients by tailoring the properties of the targeting vehicle
and the radionuclide;
• develop new technology platforms (e.g., integrated microfluidic
chips and other automated screening technologies) that would accelerate
and lower the cost of discovering and validating new molecular imaging
probes, biomarkers, and radiotherapeutic agents;
• develop higher resolution, more sensitive imaging instruments to
detect and quantify disease faster and more accurately;
• further develop and exploit hybrid imaging instruments, such as
positron emission tomography/magnetic resonance imaging (PET/MRI), to
improve disease diagnosis and treatment; and
• improve radionuclide production, chemistry, and automation to
lower the cost and increase the availability of radiopharmaceuticals by in-
venting a new miniaturized particle accelerator and associated technologies
SUMMARY 

to produce short-lived radionuclides for local use in research and clinical

programs.

In spite of these exciting possibilities, deteriorating infrastructure and

loss of federal research support are jeopardizing the advancement of nuclear
medicine. It is critical to revitalize the field to realize its potential.

CHARGE TO THE COMMITTEE

The National Academies were asked by the Department of Energy
(DOE) and the National Institutes of Health (NIH) to review the state of
the science of nuclear medicine in response to discussions between the DOE
and the Office of Management and Budget about the future scientific areas
of research for the DOE’s Medical Applications and Sciences Program. In
response to this request, the National Academies formed the Committee on
the State of the Science of Nuclear Medicine. The committee’s mandate was
to review the current state of the science in nuclear medicine; identify future
opportunities in nuclear medicine research; and identify ways to reduce the
barriers that impede both basic and translational research (Sidebar 1.1).
Although the committee is aware that funds will be required to implement
the recommendations made in this report, providing funding recommenda-
tions is beyond the scope of the committee’s charge. This report reflects the
consensus views and judgments of the committee members, based in part on
consultation with experts from academia, major medical societies, relevant
governmental agencies, and industry representatives.

FINDINGS AND RECOMMENDATIONS

Advances on the horizon in nuclear medicine could substantially ac-
celerate, simplify, and reduce the cost of delivering and improving health
care. To realize this promise, we need to focus research on the following:
(1) the development of new radionuclide production facilities and tech-
nologies; (2) the synthesis of new radiotracers to improve understanding of
how specific organs function; (3) the development of imaging instruments,
enabling technologies, and multimodality imaging devices, such as PET/CT
and PET/MRI, to improve disease diagnosis; (4) the development and use
of targeted radionuclide therapeutics that will allow cancer treatments to
be tailored for individual patients; (5) the use of nuclear medicine imaging
as a tool in the discovery and development of new drugs; and (6) the trans-
lation of research from bench to bedside, including investment in training
of clinician scientists in nuclear medicine techniques. Specific research op-
portunities are discussed in Chapters 3, 4, 6, and 7 of the report. Achieving
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