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Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
This study has been completed.

First Received on January 6, 2001.   Last Updated on April 26, 2011   History of Changes
Sponsor: American College of Radiology Imaging Network
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00008346
  Purpose

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 Intervention
Breast Cancer
 Procedure: breast imaging study
Procedure: comparison of screening methods
Procedure: radiomammography

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Digital VS. Screen-Film Mammography

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Mammography
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: October 2001
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Asymptomatic women presenting for screening mammography
  • No focal dominant lump or bloody or clear nipple discharge

  • No prior breast cancer treated with lumpectomy

    • Prior mastectomy for breast cancer allowed
  • No breast implants

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Any age

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00008346

  Show 32 Study Locations
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Investigators
Study Chair: Etta Pisano, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
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 Apr 18; [Epub ahead of print]
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.
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.
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.
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.
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. 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. Epub 2005 Sep 16.
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.
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.

ClinicalTrials.gov Identifier: NCT00008346     History of Changes
Other Study ID Numbers: CDR0000068399, ACRIN-6652
Study First Received: January 6, 2001
Last Updated: April 26, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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