Digital Mammography Screening Trial (ACRIN6652)

Breast Cancer Clinical Trial

— DMIST  

Official title:

Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00008346
• Other study ID #: CDR0000068399
• Secondary ID: ACRIN-6652U01CA0
• Status: Completed
• Phase: N/A
• First received: January 6, 2001
• Last updated: July 7, 2017
• Start date: October 2001
• Est. completion date: June 30, 2005

Study information

• Verified date: July 2017
• Source: American College of Radiology Imaging Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49528
• Est. completion date: June 30, 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Full Field Digital Mammography
Radiologic test to screen women for Breast cancer using digital detectors
• Screen Film Mammography
Radiologic test to screen women for Breast cancer using plain film detectors a resolution screen

Locations

Country	Name	City	State
Canada	Sunnybrook and Women's College Health Sciences Centre	North York	Ontario
United States	Emory Health Care Clinic	Atlanta	Georgia
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
United States	Lahey Clinic - Burlington	Burlington	Massachusetts
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Charles M. Barrett Cancer Center at University Hospital	Cincinnati	Ohio
United States	Simmons Cancer Center - Dallas	Dallas	Texas
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	La Grange Memorial Hospital	La Grange	Illinois
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Herbert Irving Comprehensive Cancer Center at Columbia University	New York	New York
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Roger Williams Medical Center/BUSM	Providence	Rhode Island
United States	Elizabeth Wende Breast Clinic	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University of California Davis Cancer Center	Sacramento	California
United States	Siteman Cancer Center	Saint Louis	Missouri
United States	University of Washington Medical Center	Seattle	Washington
United States	Shore Memorial Hospital	Somers Point	New Jersey
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	Washington Radiology Associates, P.C.	Washington, D.C.	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology Imaging Network	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (9)

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: — View Citation

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 — View Citation

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 DM — View Citation

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. — View Citation

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 mammogra — View Citation

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. R — View Citation

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: expl — View Citation

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. — View Citation

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 — View Citation