We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Breast Ultrasound and Mammography in Screening Women at High Risk for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00072501
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : October 30, 2012
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Screening tests such as ultrasound and mammography may help doctors detect cancer cells early and plan more effective treatment for breast cancer. It is not yet known whether ultrasound is more effective than mammography in detecting breast cancer.

PURPOSE: This clinical trial is studying breast ultrasound to see how well it works compared to mammography in detecting cancer in women who are at high risk for breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: breast imaging study Procedure: comparison of screening methods Procedure: magnetic resonance imaging Procedure: radiomammography Procedure: ultrasound imaging Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Screening
Official Title: Screening Breast Ultrasound in High-Risk Women
Study Start Date : April 2004
Actual Primary Completion Date : April 2012

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • At high risk for breast cancer, as defined by at least 1 of the following:

    • Known BRCA1 or BRCA2 mutation
    • Personal history of breast cancer with conserved breast analyzed separately
    • Prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, or atypical papilloma and not receiving chemoprevention (i.e., not on tamoxifen, raloxifene, anastrazole, or any other aromatase inhibitor) OR any of these atypical lesions (including phyllodes tumors) AND first-degree relative diagnosed with breast cancer under age 50
    • Prior biopsy showing lobular carcinoma in situ
    • Age 30 and under and received prior chest and/or mediastinal and/or axillary irradiation ≥ 8 years ago
    • Risk of breast cancer meeting one of the following criteria:

      • Gail or Claus lifetime cancer risk ≥ 25%
      • Gail 5-year cancer risk ≥ 2.5%
      • Gail 5-year cancer risk ≥ 1.7% AND known to have extremely dense breasts (≥ 75% dense) by most recent mammogram
  • Heterogeneously dense (≥ 50% dense) or extremely dense (≥ 75% dense throughout the entire breast) breast parenchyma in at least 1 breast by mammogram* OR unknown breast density due to no prior mammogram NOTE: *No fatty breasts or minimal scattered fibroglandular density
  • Most recent mammogram* (if any) was interpreted as negative, benign, and/or remarkable only for post-treatment changes NOTE: *At least 11 full months since prior mammogram
  • No current signs or symptoms of breast cancer (e.g., palpable breast masses, bloody or spontaneous clear nipple discharge, axillary mass, or abnormal skin changes in the breast[s] or nipple[s])

    • History of breast cancer allowed provided ≥ 1 year has elapsed since the last treatment with surgery and there is no known distant metastases and no known residual tumor
  • No bilateral breast implants

    • Participants with a unilateral breast implant who would otherwise be eligible for study participation allowed (only breast without implant is evaluated)
  • Hormone receptor status:

    • Not specified



  • 25 and over


  • Female

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Glomerular filtration rate ≥ 30 mL/min


  • Not pregnant or nursing
  • Fertile participants must use effective contraception
  • Able to undergo adequate mammography and cooperate with breast ultrasound
  • No concurrent medical or psychiatric condition that would preclude biopsy
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No contraindications to MRI (e.g., pacemaker, aneurysm clip, or other implanted magnetic device)*
  • No claustrophobia that cannot be controlled by medication with valium, ativan, or other sedative*
  • Must have intravenous access*
  • Weight < 300 pounds*
  • Physically able to tolerate positioning in the MRI scanner*
  • Able to undergo contrast-enhanced MRI within 4 weeks after completing both study ultrasound and mammogram at 24-month time point*
  • Agrees to undergo follow-up MRI at 6 months and/or MRI-guided vacuum-assisted biopsy or ultrasound-guided core biopsy (if needed)* NOTE: *MRI component of the study


Biologic therapy

  • Not specified


  • No concurrent chemotherapy (MRI component of the study)

Endocrine therapy

  • See Disease Characteristics
  • Concurrent chemoprevention with tamoxifen, raloxifene, anastrozole, exemestane or other aromatase inhibitor for participants with a personal history of cancer allowed (MRI component of the study)


  • See Disease Characteristics


  • See Disease Characteristics
  • More than 1 year since prior fine needle aspiration, core needle biopsy, or surgical procedure
  • No prior bilateral mastectomy (MRI component of the study)
  • More than 1 year since prior breast surgery on the study breast(s) (MRI component of the study)
  • More than 5 months since prior core biopsy of the study breast(s) (MRI component of the study)


  • More than 1 year since prior contrast-enhanced MRI of the breast
  • More than 1 year (≥ 11 full months) since prior whole breast bilateral ultrasound
  • More than 1 year since prior sonographic or mammographic contrast agent injection or tomosynthesis
  • More than 2 years since prior screening contrast-enhanced MRI of the study breast(s) (MRI component of the study)
  • More than 1 year since prior diagnostic contrast-enhanced MRI of the study breast(s) (MRI component of the study)
  • No concurrent participation in any other breast cancer screening trial
  • No concurrent participation in any other study involving breast MRI, sonographic or mammographic contrast agents, or tomosynthesis
  • No concurrent dialysis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072501

Show Show 20 study locations
Sponsors and Collaborators
American College of Radiology Imaging Network
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Wendie A. Berg, MD, PhD Johns Hopkins at Green Spring Station
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00072501    
Other Study ID Numbers: CDR0000339812
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: February 2006
Keywords provided by National Cancer Institute (NCI):
breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases