Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Diagnostic, Screening Completed Any age NCI ACRIN-6652 NCT00008346

Objectives

1. 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.
2. 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.
3. 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.
4. Determine the effects of technical parameters, including display type, machine type, and detector spatial and contrast resolution, on diagnostic accuracy of digital mammography.
5. 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.
6. Compare the diagnostic performance of digital mammography with the rate of cancer in a set of cases through a retrospective reader study.
7. Compare the effect of softcopy vs printed film display on the diagnostic performance of digital mammography through a retrospective reader study.
8. Compare the effect of breast density on the diagnostic accuracy of digital mammography vs screen-film mammography through a retrospective reader study.
9. Compare the image quality and breast radiation dose in digital vs screen-film mammography in these participants.
10. Determine the temporal variations in image quality, breast radiation dose, and other quality control parameters in the participating study centers.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

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

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.

• 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.

Hendrick 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]

Tosteson 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 Contact Information

Trial Lead Organizations

American College of Radiology Imaging Network

Etta Pisano, MD, Protocol chair		Ph: 919-966-6957

Registry Information
Official Title		Digital VS. Screen-Film Mammography
Trial Start Date		2001-10-29
Registered in ClinicalTrials.gov		NCT00008346
Date Submitted to PDQ		2000-11-21
Information Last Verified		2003-12-15
NCI Grant/Contract Number		CA080098