Author Contributions: Drs Zhang and Cormack had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Berg, Zhang, Mendelson, Pisano.
Acquisition of data: Berg, Mendelson, Lehrer, Böhm-Vélez, Pisano, Jong, Evans, Morton, Mahoney, Hovanessian-Larsen, Barr, Farria, Gabrielli.
Analysis and interpretation of data: Berg, Zhang, Cormack, Pisano, Marques, Adams, Yeh.
Drafting of the manuscript: Berg, Zhang.
Critical revision of the manuscript for important intellectual content: Berg, Zhang, Mendelson, Lehrer, Böhm-Vélez, Pisano, Jong, Evans, Morton, Mahoney, Hovanessian-Larsen, Barr, Farria, Gabrielli.
Statistical analysis: Zhang, Cormack, Marques, Adams, Yeh.
Obtained funding: Berg.
Administrative, technical, or material support: Berg, Mendelson, Gabrielli.
Study supervision: Berg, Zhang.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Berg reports that she has served as a consultant to Naviscan Inc and SuperSonic Imagine, has received research support from Naviscan Inc, has prepared educational materials for Gamma Medica, has a research grant from Hologic Inc, and is on the medical advisory board of Philips. Dr Mendelson reports that she is a member of the scientific advisory boards of MediPattern, Hologic, and Siemens and has received equipment support from Philips and research support from SuperSonic Imagine and Siemens. Dr Böhm-Vélez reports that she is a member of the scientific advisory board of Philips, does clinical validation studies for Philips Ultrasound, and is on the speakers bureau of Dilon. Dr Pisano reports that her laboratory received research support from GE Healthcare, Konica Minolta, Sectra AB, Naviscan Inc, Koning, Zumatek, Inc, equipment grants from R2 and iCAD, is a board member of ACR Imaging Metrix and NextRay Inc, and a stockholder in NextRay Inc. Dr Jong reports that she is a consultant to and receives research support from GE Healthcare. Dr Evans reports that he is a member of the scientific advisory board of Hologic. Dr Mahoney reports that she is a consultant to Ethicon EndoSurgery and SenoRx and on the scientific advisory board of Hologic and receives research support from Naviscan Inc. Dr Larsen reports that she receives equipment support from Naviscan Inc. Dr Barr reports that he is a member of the ultrasound advisory boards of and has received equipment support, research support, and speakers fees from Siemens and Philips, an equipment grant from SuperSonic Inc, and a research grant from Bracco. The remaining coauthors report no financial disclosures.
ACRIN 6666 Site Investigators and Research Assistants: Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania: William R. Poller, MD, principal investigator (PI), and Michelle Huerbin; American Radiology Services–Johns Hopkins Green Spring, Baltimore, Maryland: Wendie A. Berg, MD, PhD (PI), Barbara E. Levit, RT, and Kathy Wetzel; Beth Israel Deaconess Medical Center, Boston, Massachusetts: Janet K. Baum, MD, and Valerie J. Fein-Zachary, MD (PIs), and Suzette M. Kelleher, BA; CERIM, Buenos Aires, Argentina: Daniel E. Lehrer, MD (PI), and Maria S. Ostertag; Duke University Medical Center, Durham, North Carolina: Mary Scott Soo, MD (PI), and Brenda N. Prince, RT; Mayo Clinic, Rochester, Minnesota: Marilyn J. Morton, DO (PI), and Lori M. Johnson, AAS; Feinberg School of Medicine, Northwestern University, Chicago, Illinois: Ellen B. Mendelson, MD (PI), and Marysia Kalata, AA; Radiology Associates of Atlanta, Atlanta, Georgia: Handel Reynolds, MD (PI), and Y. Suzette Wheeler, RN, MSHA; Radiology Consultants/Forum Health, Youngstown, Ohio: Richard G. Barr, MD, PhD (PI), and Marilyn J. Mangino, RN; Radiology Imaging Associates, Denver, Colorado: A. Thomas Stavros, MD (PI), and Margo Valdez; Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada: Roberta A. Jong, MD (PI), and Julie H. Lee, BSC; Thomas Jefferson University Hospital, Philadelphia, Pennsylvania: Catherine W. Piccoli, MD, and Christopher R. B. Merritt, MS, MD (PIs), and Colleen Dascenzo; David Geffen School of Medicine at University of California Los Angeles Medical Center, Los Angeles: Anne C. Hoyt, MD (PI), and Roslynn Marzan, BS; University of Cincinnati Medical Center, Cincinnati, Ohio: Mary C. Mahoney, MD (PI), and Monene M. Kamm, AS; University of North Carolina, Chapel Hill: Etta D. Pisano, MD (PI), and Laura A. Tuttle, MA; Keck School of Medicine, University of Southern California, Los Angeles: Linda H. Larsen, MD (PI), and Christina E. Kiss, AA; University of Texas MfD Anderson Cancer Center, Houston: Gary J. Whitman, MD (PI), and Sharon R. Rice, AA; University of Texas Southwestern Medical Center, Dallas: W. Phil Evans, MD (PI), and Kimberly T. Taylor, AA; Washington University School of Medicine, St Louis, Missouri: Dione M. Farria, MD, MPH (PI), and Darlene J. Bird, RT, AS; and Weinstein Imaging Associates, Pittsburgh, Pennsylvania: Marcela Böhm-Vélez, MD, (PI), and Antoinette Cockroft.
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 or conduct of the study; collection, management, analysis, or interpretation of the data; or 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 or conduct of the study; collection, management, analysis, or interpretation of the data; or preparation, review, or approval of the manuscript.
Previous Presentation: Presented at the 2009 Radiologic Society of North America Scientific Assembly, Chicago, Illinois, December 1, 2009.
Online-Only Material: The Author Video Interview is available hereThe Author Audio Inverview is available here
. The full protocol is available online at http://acrin.org/Portals/0/Protocols/6666/Protocol-ACRIN%206666%20Admin%20Update%2011.30.07.pdf.
Additional Contributions: We thank Jeffrey Blume, PhD, Vanderbilt University, Nashville, Tennessee, for his contributions to initial study design and supervision and Robert A. Smith, PhD, American Cancer Society, Atlanta, Georgia, for review and helpful discussions. We especially thank Marydale DeBor, JD, Chief Advisor Avon Breast Cancer Crusade 1993-2003, who was instrumental in securing the support within the Avon Foundation that made this study possible, and Marc Hurlbert, PhD, of the Avon Foundation for his continued vision and unwavering support. We are indebted to the many investigators, coinvestigators, and research assistants at the clinical sites. We appreciate the efforts of ACRIN Data Management and Imaging staff, and we especially thank Cynthia Olson, MBA, MHS, for administrative oversight. We thank Eric Berns, PhD, University of Colorado, Denver, for ultrasound image quality control and R. Edward Hendrick, PhD, University of Colorado, for MRI imaging quality control. No one was compensated beyond their usual salary for their efforts for this study. We are especially grateful to the 2809 women who enrolled in this study.