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Digital VS. Screen-Film Mammography


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Female
Breast Cancer

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Trial Information

Digital VS. Screen-Film Mammography


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Screening

Principal Investigator

Etta Pisano, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068399

NCT ID:

NCT00008346

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of Washington Medical CenterSeattle, Washington  98195-6043
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Mount Sinai School of MedicineNew York, New York  10029
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Roger Williams Medical Center/BUSMProvidence, Rhode Island  02908-4735
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Lahey Clinic - BurlingtonBurlington, Massachusetts  01805
Allegheny General HospitalPittsburgh, Pennsylvania  15212-4772
William Beaumont HospitalRoyal Oak, Michigan  48073
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
University of California Davis Cancer CenterSacramento, California  95817
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Siteman Cancer CenterSaint Louis, Missouri  63110
La Grange Memorial HospitalLa Grange, Illinois  60525
Washington Radiology Associates, P.C.Washington, District of Columbia  20037
Emory Health Care ClinicAtlanta, Georgia  30322
Shore Memorial HospitalSomers Point, New Jersey  08244
Elizabeth Wende Breast ClinicRochester, New York  14620