Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists

Breast cancer screening with whole breast ultrasound

Whole breast ultrasound

Wendie Berg, MD, PhD

The purpose of this study is to evaluate the role of technologist-performed whole breast ultrasound for detecting breast cancer in the screening population of women with dense breasts.

This is a prospective study designed to evaluate the role of whole breast ultrasound (WBUS) in screening for breast cancer. In particular, there is interest in investigating the value of using WBUS as an adjunct (supplementary imaging) to Digital Breast Tomosynthesis (DBT) based screening of women with dense (heterogeneously or extremely dense) breasts or as a primary screening examination in this group of women. Women scheduled for their routine mammography that includes a DBT exam who agree to participate in the study and sign informed consent will undergo (at the same visit) DBT imaging as part of their clinical exam and whole breast ultrasound (WBUS) each year for three rounds of screening plus one year of follow-up. The DBT images and WBUS will be interpreted independently by two experienced radiologists under standard clinical screening procedures. One radiologist will interpret the DBT and the other radiologist will interpret the WBUS. Using a modified "LOGICAL OR" approach women/subjects may be recalled for further diagnostic work-up (examinations). If a subject is recalled, she will then follow the standard/routine clinical procedures for follow-up and the investigators will verify outcomes. If neither radiologist recalls the subject, then the subject will follow conventional management and the investigators will verify outcome. The findings from the DBT and WBUS examinations, as well as any resulting follow-up, will be collected, recorded and analyzed.

Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT

Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT (Also Known as "DBTUST-Dense Breast Tomosynthesis / Ultrasound Screening Trial")

Results from the first radiologist observer are presented

DBT true positive findings for first observer (usual care) vs DBT and WBUS true positive findings for first observer

DBT false-positive findings for first observer (usual care) vs DBT and WBUS false positive findings for first observer

Counts and percentages of participants diagnosed with cancer and detected by first observer with DBT only, DBT and WBUS, and WBUS only

National Cancer Institute (NCI)

Wendie Berg

Professor of Radiology

All women will receive both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation will vary for each of two radiologists

Whole breast ultrasound: Breast cancer screening with whole breast ultrasound

Whole Breast Ultrasound

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Breast Density

After exclusions, we analyzed the results from 6,179 women overall

Dr. Wendie A. Berg

The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added cancer detection rate (CDR) from US of 1.1/1,000. Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.

Screen 1

Screens 2 & 3

All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT alone.

Digital Breast Tomosynthesis (DBT)

All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the cancer yield per 1,000 for DBT+WBUS.

DBT and WBUS

Screens 2 \& 3 include women who were analyzable after the end of Screening Round 2

Cancer Yield Per 1,000

The primary unit of analysis was the screening examination. A sample size of 16,700 screens (6,200 women, estimating 8%-10% loss to follow-up each year) was expected to provide 82% power to identify an added CDR from US of 1.1/1,000.Screens were included for analysis if the patient was diagnosed with breast cancer or at least 10.5-month imaging or clinical follow-up (ie, at end of study participation) showed no evidence of breast cancer.

Year/Screen 1

Years/Screens 2 & 3

All women received both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation varied for each of two radiologists. This Arm looks at the sensitivity of DBT alone for reader 1.

Digital Breast Tomosynthesis

All women received both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation varied for each of two radiologists. This Arm looks at the sensitivity of DBT and WBUS for reader 1.

Sensitivity (True Positive Rate)

No. of Cancers

No. of invasive cancers

No. of Node-positive among available staging

All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the number of cancers detected by first observer for DBT Alone.

All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the number of cancers detected by first observer for DBT and WBUS.

All women received both 3D mammography (DBT) and whole breast ultrasound (WBUS) for breast cancer screening. This Arm looks at the number of cancers detected by first observer for WBUS alone.

WBUS Only

Cancers detected by first observer for all 3 Screenings/Years combined

Types of Abnormalities Detected by Ultrasound and Tomosynthesis

All women received both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation varied for each of two radiologists. This Arm looks at the false-positive recall rate of DBT alone for reader 1.

All women received both 3D mammography and whole breast ultrasound for breast cancer screening; the order of interpretation varied for each of two radiologists. This arm looks at the false-positive recall rate of DBT and WBUS for reader 1.

Spots Global Cancer Trial Database for whole breast ultrasound