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N/A N=6,266 Screening

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

Breast Cancer

Enrolled (actual)
6,266
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Cancer Yield Per 1,000 — 5.0; 6.3; 4.9; 5.9 Cancer yield per 1,000 — p=0.005

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Whole breast ultrasound (Device)
Age
Adult, Older Adult · 40+ yrs
Sex
Female
Sponsor
Wendie Berg
Primary completion
May 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Cancer Yield Per 1,000
5.0; 6.3; 4.9; 5.9 0.005 sig
PRIMARY
Sensitivity (True Positive Rate)
68.9; 86.7; 69.1; 82.7 0.005 sig
PRIMARY
False-positive Recall Rate
7.0; 11.5; 5.9; 9.7 < 0.001 sig
SECONDARY
Types of Abnormalities Detected by Ultrasound and Tomosynthesis
55; 32; 19; 32; 31; 16

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • Women aged 40 to 75 years of age with heterogeneously dense or extremely dense parenchyma by prior digital mammography report (i.e., "dense breasts"), presenting for routine annual mammography with digital breast tomosynthesis.

Exclusion Criteria

  • Known to be at high risk for breast cancer due to known or suspected pathologic BRCA mutation (i.e. first-degree relative with known mutation) or prior chest radiation therapy before age 30;
  • No mammogram within the prior 3 years;
  • Signs or symptoms of breast disease including lump, bloody or spontaneous clear nipple discharge, eczema of the nipple;
  • Pregnancy or lactation within the prior 6 months;
  • Plan to become pregnant in the next two years, as mammography is not typically performed for screening pregnant women;
  • Breast implants, as assessment of breast density may be problematic;
  • Recent prior breast surgery or breast biopsy or cyst aspiration within the prior 12 months;
  • Prior or current malignancy other than the following: a) Breast cancer at least one year earlier (12 full months have elapsed since the last treatment surgery) with no known distant metastases and no known residual tumor; or b) Basal or squamous cell skin cancer or in situ cervical cancer or stage I thyroid cancer; or c) Other cancer for which the patient has been disease free for ≥ 5 years, with no recurrence of cancer in the last five years and no residual disease detected in the last five years.
  • Screening contrast-enhanced MRI or 99mTc-sestamibi based imaging of the breast(s) within the prior 12 months or planned within the next two years, to avoid contamination of results;
  • Unwilling or unable to provide consent.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02643966). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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