Assessment of Periodic Screening of Women With Denser Breast Using WBUS and DBT
Completed · Not applicable
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT02643966
- Run by
- Wendie Berg
- People needed
- 6266
- Starts
- 2015-12-01
- Expected to finish
- 2022-05-01
- Last updated by the study team
- 2023-06-29
Who can join
Age: 40 and older, up to 75. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Weinstein Imaging Associates — Pittsburgh, Pennsylvania, United States
- Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.