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Randomized Screening and Diagnostic Study of Digital Mammography Versus Screen-Film Mammography in the Detection of Breast Cancer in Women
Alternate Title Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
Objectives
Entry Criteria Disease Characteristics:
Prior/Concurrent Therapy: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Patient Characteristics: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
Expected Enrollment A total of 49,500 participants (24,750 per arm) will be accrued for this study within 18 months. Outline This is a randomized, multicenter study. Participants with postitive screening results are stratified according to age (under 50 vs 50-59 vs 60-70 vs over 70). Participants are randomized to one of two treatment arms.
Quality of life is assessed before the screening mammogram in the first 800 women enrolled. In an additional 1,200 participants (600 with positive screening results and 600 with negative screening results), quality of life is assessed shortly after the screening mammogram and at 1 year. Participants are followed at 1 year with a repeat screen-film or digital mammogram. Published ResultsHendrick RE, Cole EB, Pisano ED, et al.: Accuracy of soft-copy digital mammography versus that of screen-film mammography according to digital manufacturer: ACRIN DMIST retrospective multireader study. Radiology 247 (1): 38-48, 2008.[PUBMED Abstract] Pisano ED, Hendrick RE, Yaffe MJ, et al.: Diagnostic accuracy of digital versus film mammography: exploratory analysis of selected population subgroups in DMIST. Radiology 246 (2): 376-83, 2008.[PUBMED Abstract] Bloomquist AK, Yaffe MJ, Pisano ED, et al.: Quality control for digital mammography in the ACRIN DMIST trial: part I. Med Phys 33 (3): 719-36, 2006.[PUBMED Abstract] Yaffe MJ, Bloomquist AK, Mawdsley GE, et al.: Quality control for digital mammography: part II. Recommendations from the ACRIN DMIST trial. Med Phys 33 (3): 737-52, 2006.[PUBMED Abstract] Pisano ED, Gatsonis CA, Yaffe MJ, et al.: American College of Radiology Imaging Network digital mammographic imaging screening trial: objectives and methodology. Radiology 236 (2): 404-12, 2005.[PUBMED Abstract] Pisano ED, Gatsonis C, Hendrick E, et al.: Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med 353 (17): 1773-83, 2005.[PUBMED Abstract] Related PublicationsTosteson AN, Stout NK, Fryback DG, et al.: Cost-effectiveness of digital mammography breast cancer screening. Ann Intern Med 148 (1): 1-10, 2008.[PUBMED Abstract] Trial Lead Organizations American College of Radiology Imaging Network
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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