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Status:

COMPLETED

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

Lead Sponsor:

American College of Radiology Imaging Network

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

FEMALE

25+ years

Phase:

NA

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 ...

Detailed Description

OBJECTIVES: Primary * Determine the diagnostic yield of whole breast bilateral screening ultrasound and mammography for the detection of breast cancer in women at high risk for breast cancer. * Dete...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 25 and over
  • Sex
  • Female
  • Menopausal status
  • Not specified
  • Performance status
  • Not specified
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Not specified
  • Hepatic
  • Not specified
  • Renal
  • Glomerular filtration rate ≥ 30 mL/min
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • 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)
  • Radiotherapy
  • See Disease Characteristics
  • Surgery
  • 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)
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00072501

    Start Date

    April 1 2004

    Last Update

    October 30 2012

    Active Locations (20)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 5 (20 locations)

    1

    USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, United States, 90089-9181

    2

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1781

    3

    Invision - Radiology Imaging Associates

    Greenwood Village, Colorado, United States, 80111

    4

    Radiology Associates of Atlanta

    Atlanta, Georgia, United States, 30309