Digital Mammography Screening Trial (ACRIN6652) (DMIST)

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ClinicalTrials.gov Identifier: NCT00008346

Recruitment Status : Completed

First Posted : January 27, 2003

Last Update Posted : July 11, 2017

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

American College of Radiology Imaging Network

Study Description

Brief Summary:

RATIONALE: Screening tests may help doctors detect cancer cells early and plan more effective treatment for cancer. It is not yet known which type of mammography is more effective in detecting breast cancer.

PURPOSE: Screening and diagnostic trial to compare the effectiveness of two types of mammography in detecting breast cancer in women.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Diagnostic Test: Full Field Digital Mammography Diagnostic Test: Screen Film Mammography	Not Applicable

Detailed Description:

OBJECTIVES:

Compare the diagnostic performance of digital mammography vs screen-film mammography, as measured by the area under the Receiver Operating Characteristic (ROC) curve, sensitivity, specificity, and positive and negative predictive values, in the detection of breast cancer in women.
Compare the diagnostic accuracy of the digital mammogram obtained using each of the individual manufacturer's digital units vs screen-film mammography through retrospective reader studies.
Determine the effects of patient characteristics, including age, lesion type, pathologic diagnosis, menopausal and hormonal status, breast density, and family history, on diagnostic accuracy of digital mammography.
Determine the effects of technical parameters, including display type, machine type, and detector spatial and contrast resolution, on diagnostic accuracy of digital mammography.
Determine the effect of reduced false-positive mammograms that are expected with digital mammography on the health-related quality of life and personal anxiety of women undergoing this screening experience.
Compare the diagnostic performance of digital mammography with the rate of cancer in a set of cases through a retrospective reader study.
Compare the effect of softcopy vs printed film display on the diagnostic performance of digital mammography through a retrospective reader study.
Compare the effect of breast density on the diagnostic accuracy of digital mammography vs screen-film mammography through a retrospective reader study.
Compare the image quality and breast radiation dose in digital vs screen-film mammography in these participants.
Determine the temporal variations in image quality, breast radiation dose, and other quality control parameters in the participating study centers.

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.

Arm I: Participants undergo a two-view screen-film mammogram followed by a two-view digital mammogram of each breast.
Arm II: Participants undergo a two-view digital mammogram followed by a two-view screen-film mammogram of each breast.

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.

PROJECTED ACCRUAL: A total of 49,500 participants (24,750 per arm) will be accrued for this study within 18 months.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	49528 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Screening
Official Title:	Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
Actual Study Start Date :	October 2001
Actual Primary Completion Date :	February 2005
Actual Study Completion Date :	June 30, 2005

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer

MedlinePlus related topics: Breast Cancer Mammography

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
SFM then FFDM Screen Film Mammography (SFM) followed by Full Field Digital Mammography (FFDM)	Diagnostic Test: Full Field Digital Mammography Radiologic test to screen women for Breast cancer using digital detectors Other Names: FFDM Digital Mammography Diagnostic Test: Screen Film Mammography Radiologic test to screen women for Breast cancer using plain film detectors a resolution screen Other Names: SFM Plain Film Mamography
FFDM then SFM Full Field Digital Mammography (FFDM) followed by Screen Film Mammography (SFM)	Diagnostic Test: Full Field Digital Mammography Radiologic test to screen women for Breast cancer using digital detectors Other Names: FFDM Digital Mammography Diagnostic Test: Screen Film Mammography Radiologic test to screen women for Breast cancer using plain film detectors a resolution screen Other Names: SFM Plain Film Mamography

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	up to 120 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

4.1 Inclusion Criteria 4.1.1 All consecutive women presenting for screening mammography at the participating institutions will be eligible.

4.1.2 Signed study-specific informed consent. See Appendix I. 4.2 Exclusion Criteria 4.2.1 All women who have presented with a complaint of a focal dominant lump or a bloody or clear nipple discharge.

4.2.2 All women who have breast implants. 4.2.3 Any woman who is pregnant or has reason to believe that she might be pregnant.

4.2.4 Participants who cannot, for any reason, undergo follow-up screen-film mammography at the participating institution or provide mammograms from another institution for review for one year after study entry.

4.2.5 All women with a history of breast cancer treated with lumpectomy. Note: Women with a history of breast cancer treated with mastectomy who have now returned to a screening population will still be included in the study.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00008346

Locations

Show 32 study locations

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80010
United States, District of Columbia
Washington Radiology Associates, P.C.
Washington, D.C., District of Columbia, United States, 20037
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Emory Health Care Clinic
Atlanta, Georgia, United States, 30322
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60610
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Clinic - Burlington
Burlington, Massachusetts, United States, 01805
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Missouri
Siteman Cancer Center
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Shore Memorial Hospital
Somers Point, New Jersey, United States, 08244
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10003
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Elizabeth Wende Breast Clinic
Rochester, New York, United States, 14620
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0772
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212-4772
United States, Rhode Island
Roger Williams Medical Center/BUSM
Providence, Rhode Island, United States, 02908-4735
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75390-8585
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98112
Canada, Ontario
Sunnybrook and Women's College Health Sciences Centre
North York, Ontario, Canada, M4N 3M5

Sponsors and Collaborators

American College of Radiology Imaging Network

National Cancer Institute (NCI)

Investigators

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Study Chair:	Etta Pisano, MD	UNC Lineberger Comprehensive Cancer Center

More Information

Publications of Results:

Baum JK, Hanna LG, Acharyya S, Mahoney MC, Conant EF, Bassett LW, Pisano ED. Use of BI-RADS 3-probably benign category in the American College of Radiology Imaging Network Digital Mammographic Imaging Screening Trial. Radiology. 2011 Jul;260(1):61-7. doi: 10.1148/radiol.11101285. Epub 2011 Apr 18.

Hendrick RE, Cole EB, Pisano ED, Acharyya S, Marques H, Cohen MA, Jong RA, Mawdsley GE, Kanal KM, D'Orsi CJ, Rebner M, Gatsonis C. Accuracy of soft-copy digital mammography versus that of screen-film mammography according to digital manufacturer: ACRIN DMIST retrospective multireader study. Radiology. 2008 Apr;247(1):38-48. doi: 10.1148/radiol.2471070418.

Pisano ED, Hendrick RE, Yaffe MJ, Baum JK, Acharyya S, Cormack JB, Hanna LA, Conant EF, Fajardo LL, Bassett LW, D'Orsi CJ, Jong RA, Rebner M, Tosteson AN, Gatsonis CA; DMIST Investigators Group. Diagnostic accuracy of digital versus film mammography: exploratory analysis of selected population subgroups in DMIST. Radiology. 2008 Feb;246(2):376-83. doi: 10.1148/radiol.2461070200.

Bloomquist AK, Yaffe MJ, Pisano ED, Hendrick RE, Mawdsley GE, Bright S, Shen SZ, Mahesh M, Nickoloff EL, Fleischman RC, Williams MB, Maidment AD, Beideck DJ, Och J, Seibert JA. Quality control for digital mammography in the ACRIN DMIST trial: part I. Med Phys. 2006 Mar;33(3):719-36. doi: 10.1118/1.2163407.

Yaffe MJ, Bloomquist AK, Mawdsley GE, Pisano ED, Hendrick RE, Fajardo LL, Boone JM, Kanal K, Mahesh M, Fleischman RC, Och J, Williams MB, Beideck DJ, Maidment AD. Quality control for digital mammography: part II. Recommendations from the ACRIN DMIST trial. Med Phys. 2006 Mar;33(3):737-52. doi: 10.1118/1.2164067.

Pisano ED, Gatsonis CA, Yaffe MJ, Hendrick RE, Tosteson AN, Fryback DG, Bassett LW, Baum JK, Conant EF, Jong RA, Rebner M, D'Orsi CJ. American College of Radiology Imaging Network digital mammographic imaging screening trial: objectives and methodology. Radiology. 2005 Aug;236(2):404-12. doi: 10.1148/radiol.2362050440. Epub 2005 Jun 16.

Pisano ED, Gatsonis C, Hendrick E, Yaffe M, Baum JK, Acharyya S, Conant EF, Fajardo LL, Bassett L, D'Orsi C, Jong R, Rebner M; Digital Mammographic Imaging Screening Trial (DMIST) Investigators Group. Diagnostic performance of digital versus film mammography for breast-cancer screening. N Engl J Med. 2005 Oct 27;353(17):1773-83. doi: 10.1056/NEJMoa052911. Epub 2005 Sep 16. Erratum In: N Engl J Med. 2006 Oct 26;355(17):1840.

Other Publications:

Hendrick RE, Pisano ED, Averbukh A, Moran C, Berns EA, Yaffe MJ, Herman B, Acharyya S, Gatsonis C. Comparison of acquisition parameters and breast dose in digital mammography and screen-film mammography in the American College of Radiology Imaging Network digital mammographic imaging screening trial. AJR Am J Roentgenol. 2010 Feb;194(2):362-9. doi: 10.2214/AJR.08.2114.

Tosteson AN, Stout NK, Fryback DG, Acharyya S, Herman BA, Hannah LG, Pisano ED; DMIST Investigators. Cost-effectiveness of digital mammography breast cancer screening. Ann Intern Med. 2008 Jan 1;148(1):1-10. doi: 10.7326/0003-4819-148-1-200801010-00002.

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Responsible Party:	American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:	NCT00008346
Other Study ID Numbers:	CDR0000068399 ACRIN-6652 ( Other Identifier: American College of Radiology ) U01CA080098 ( U.S. NIH Grant/Contract ) U01CA079778 ( U.S. NIH Grant/Contract )
First Posted:	January 27, 2003 Key Record Dates
Last Update Posted:	July 11, 2017
Last Verified:	July 2017

Keywords provided by American College of Radiology Imaging Network:


breast cancer

Additional relevant MeSH terms:

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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

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