Screening Breast Ultrasound in High-Risk Women
- 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.
- Determine the cancer detection yield of a single contrast-enhanced magnetic resonance
imaging (MRI) examination after 3 rounds of annual screening with ultrasound and
mammography in these participants. (MRI component of the study)
- Determine the independent sensitivity and specificity of these screening methods in
- Correlate performance of these screening methods with selected participant
characteristics (e.g., breast density and heterogeneity of the parenchyma).
- Validate the sonographic classification of lesions as "probably benign" and estimate
the rate of malignancy in participants screened with these methods.
- Determine the cost effectiveness associated with screening breast ultrasound, in terms
of radiologist and resource time performing the exam and the induced cost of screening
ultrasound (e.g., follow-up and biopsy).
- Determine the reproducibility of lesion identification, measurement of lesion
diameters, and volume and recording of lesion location on ultrasound in these
- Determine the size, type, grade, and nodal status of cancers seen only on MRI in these
participants. (MRI component of the study)
- Estimate the rate of benign biopsies and short interval follow-up induced only by MRI
in these participants. (MRI component of the study)
- Determine the cost effectiveness of MRI, including induced costs of unnecessary
biopsies and follow-up. (MRI component of the study)
- Compare the agreement among multiple examiners in sonographic, mammographic, and MRI
feature analysis (using terms from the BI-RADS® lexicon) and final assessment (e.g.,
estimated probability of malignancy and/or recommendation for biopsy) in the enriched
set of diagnostic training cases with consensus and histopathologic reference
OUTLINE: This is a randomized, multicenter study. Participants are randomized to 1 of 2
- Arm I: Participants undergo physician-performed bilateral whole breast ultrasound (US)
followed by mammogram within 2 weeks.
- Arm II: Participants undergo mammogram followed by physician-performed bilateral whole
breast US within 2 weeks.
In both arms, participants with negative or benign findings are rescreened according to
their screening arm at 1 and 2 years. Participants with "probably benign" findings are
rescreened at the 6-month follow-up visit. Participants with findings that are suspicious or
highly suggestive of malignancy are recommended for biopsy.
A subset of participants* in both arms undergo contrast-enhanced breast MRI within 4 weeks
after completion of the 2-year screening US and mammogram. Participants with "probably
benign" findings seen only on MRI may undergo an additional breast MRI at the 6-month
follow-up visit. Participants with additional suspicious lesions seen only on MRI undergo
second-look targeted US for biopsy guidance or MRI-guided vacuum-assisted biopsy after
completion of any biopsies or additional views prompted by the 2-year screening US and
NOTE: *No diagnosis of metastatic cancer of any type since entering this clinical trial.
Participants are followed annually for 3 years.
PROJECTED ACCRUAL: A total of 2,808 participants will be accrued for this study within 2
Allocation: Randomized, Primary Purpose: Screening
Wendie A. Berg, MD, PhD
Johns Hopkins at Green Spring Station
United States: Federal Government
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Siteman Cancer Center at Barnes-Jewish Hospital||Saint Louis, Missouri 63110|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Charles M. Barrett Cancer Center at University Hospital||Cincinnati, Ohio 45267-0526|
|Kimmel Cancer Center at Thomas Jefferson University - Philadelphia||Philadelphia, Pennsylvania 19107|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|M.D. Anderson Cancer Center at University of Texas||Houston, Texas 77030|
|Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas||Dallas, Texas 75390|
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University||Chicago, Illinois 60611|
|Allegheny Cancer Center at Allegheny General Hospital||Pittsburgh, Pennsylvania 15212|
|Radiology Consultants, Incorporated||Youngstown, Ohio 44512|
|Invision - Radiology Imaging Associates||Greenwood Village, Colorado 80111|
|Radiology Associates of Atlanta||Atlanta, Georgia 30309|
|Johns Hopkins at Green Spring Station||Lutherville, Maryland 21093|
|Weinstein Imaging Associates||Pittsburgh, Pennsylvania 15206|