Author Contributions: Dr Blume had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Berg, Blume, Mendelson, Pisano.
Acquisition of data: Berg, Blume, Mendelson, Lehrer, Böhm-Vélez, Pisano, Jong, Evans, Morton, Mahoney, Hovanessian-Larsen, Barr, Farria, Boparai.
Analysis and interpretation of data: Berg, Blume, Cormack, Mendelson, Pisano, Marques.
Drafting of the manuscript: Berg, Blume, Cormack, Marques.
Critical revision of the manuscript for important intellectual content: Berg, Blume, Mendelson, Lehrer, Böhm-Vélez, Pisano, Jong, Evans, Morton, Mahoney, Hovanessian-Larsen, Barr, Farria, Boparai.
Statistical analysis: Blume, Cormack, Marques.
Obtained funding: Berg, Blume.
Administrative, technical, or material support: Berg, Mendelson, Lehrer, Pisano, Jong, Morton, Barr, Boparai.
Study supervision: Berg, Blume.
Financial Disclosures: Dr Berg reports that she has served as a consultant to Naviscan PET Systems, MediPattern, and Siemens and has received equipment support from Siemens and a travel grant from General Electric. Dr Mendelson reports that she is a member of the scientific advisory boards of MediPattern and Siemens and has received equipment support from Philips. Dr Böhm-Vélez reports that she is a member of the physicians advisory board of MediPattern. Dr Pisano reports that her laboratory receives research support from General Electric, Hologic, Konica, Sectra, and Siemens. Dr Jong reports that she has a research collaboration with General Electric. Dr Evans reports that he is a member of the scientific advisory board of Hologic. Dr Mahoney reports that she is a consultant to Johnson & Johnson and SenoRx. Dr Larsen reports that she receives equipment support from Naviscan PET Systems. Dr Barr reports that he is a member of the ultrasound advisory boards of and has received equipment support from Siemens and Philips. The remaining coauthors report no financial disclosures.
ACRIN 6666 Site Investigators:Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania: William R. Poller, MD, principal investigator (PI), Michelle Huerbin, research associate (RA); American Radiology Services–Johns Hopkins Green Spring, Baltimore, Maryland: Wendie A. Berg, MD, PhD (PI), Barbara E. Levit, RT (RA); Beth Israel Deaconess Medical Center, Boston, Massachusetts:Janet K. Baum, MD, and Valerie J. Fein-Zachary, MD (PIs), Suzette M. Kelleher, BA (RA); CERIM, Buenos Aires: Daniel E. Lehrer, MD (PI), Maria S. Ostertag (RA); Duke University Medical Center, Durham, North Carolina: Mary Scott Soo, MD (PI), Brenda N. Prince, RT (RA); Mayo Clinic, Rochester, Minnesota: Marilyn J. Morton, DO (PI), Lori M. Johnson, AAS (RA); Feinberg School of Medicine, Northwestern University, Chicago, Illinois: Ellen B. Mendelson, MD (PI), Marysia Kalata, AA (RA); Radiology Associates of Atlanta, Atlanta, Georgia: Handel Reynolds, MD (PI), Y. Suzette Wheeler, RN, MSHA (RA); Radiology Consultants/Forum Health, Youngstown, Ohio: Richard G. Barr, MD, PhD (PI), Marilyn J. Mangino, RN (RA); Radiology Imaging Associates, Denver, Colorado: A. Thomas Stavros, MD (PI), Margo Valdez (RA); Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada: Roberta A. Jong, MD (PI), Julie H. Lee, BSC (RA); Thomas Jefferson University Hospital, Philadelphia, Pennsylvania: Catherine W. Piccoli, MD, and Christopher R. B. Merritt, MS, MD (PIs), Colleen Dascenzo (RA); David Geffen School of Medicine at University of California Los Angeles Medical Center, Los Angeles: Anne C. Hoyt, MD (PI), Roslynn Marzan, BS (RA); University of Cincinnati Medical Center, Cincinnati, Ohio: Mary C. Mahoney, MD (PI), Monene M. Kamm, AS (RA); University of North Carolina, Chapel Hill: Etta D. Pisano, MD (PI), Laura A. Tuttle, MA (RA), Keck School of Medicine, University of Southern California, Los Angeles: Linda Hovanessian Larsen, MD (PI), Christina E. Kiss, AA (RA); University of Texas M. D. Anderson Cancer Center, Houston: Gary J. Whitman, MD (PI), Sharon R. Rice, AA (RA); University of Texas Southwestern Medical Center, Dallas: W. Phil Evans, MD (PI), Kimberly T. Taylor, AA (RA); Washington University School of Medicine, St. Louis, Missouri: Dione M. Farria, MD, MPH (PI), Darlene J. Bird, RT, AS (RA); and Weinstein Imaging Associates, Pittsburgh, Pennsylvania: Marcela Böhm-Vélez, MD, (PI), Antoinette Cockroft (RA).
Funding/Support: The study was funded by the Avon Foundation and grants CA 80098 and CA 79778 from the National Cancer Institute.
Role of the Sponsors: The Avon Foundation was not involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. The trial was conducted by the American College of Radiology Imaging Network, a member of the National Cancer Institute's Clinical Trials Cooperative Groups Program, and was developed and carried out adhering to the standard cooperative group processes. These processes include review of and input about the trial design from the NCI's Cancer Therapy Evaluation Program (CTEP). Upon CTEP's approval of the research protocol, the NCI was not involved in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
Additional Contributions: We thank Amanda M. Adams, MPH, Center for Statistical Sciences, Brown University, Providence, Rhode Island, for assistance with data analysis; Eric A. Berns, PhD, University of Colorado, Denver, for ultrasound quality assurance; Cynthia B. Olson, MBA, MHS, and Sophia Sabina, MBA, American College of Radiology (ACR), Philadelphia, Pennsylvania, for administrative assistance; Glenna J. Gabrielli, BS, Stephanie Clabo, BS, CCRP, Jillene DeBari, BA, and Judy M. Green, RT(M) at ACR for data management; Cheryl L. Crozier, RN, ASQ, CQA, and Josephine Schloesser, AS, RT(R)(M), CCRP at ACR for monitoring; Anthony M. Levering, AS, RT(R)(CT)(MR) at ACR for image management; and Nancy S. Fredericks, MBA, at ACR for communications support. We also thank Cecilia M. Brennecke, MD, and other colleagues at American Radiology Services, Johns Hopkins Green Spring, for their support; and Mark D. Schleinitz, MD, MS, at Brown University, Barbara K. LeStage, BS, MHP, consultant to the ACR, Edward A. Sickles, MD, University of California, San Francisco Medical Center, and Elizabeth A. Patterson, MD, Seattle, Washington, for engaging in helpful discussions. We are indebted to the many investigators, coinvestigators, and research associates at the clinical sites. No one was compensated beyond their usual salary for their efforts for this study.
This article was corrected online for typographical errors on 4/21/2010.