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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.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00008346
First received: January 6, 2001
Last updated: April 26, 2011
Last verified: December 2003

January 6, 2001
April 26, 2011
October 2001
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Complete list of historical versions of study NCT00008346 on ClinicalTrials.gov Archive Site
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Screening and Diagnostic Trial to Compare the Effectiveness of Two Types of Mammography in Detecting Breast Cancer in Women
Digital VS. Screen-Film Mammography

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.

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.

Interventional
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Primary Purpose: Screening
Breast Cancer
  • Procedure: breast imaging study
  • Procedure: comparison of screening methods
  • Procedure: radiomammography
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00008346
CDR0000068399, ACRIN-6652
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American College of Radiology Imaging Network
National Cancer Institute (NCI)
Study Chair: Etta Pisano, MD UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP