Assessment of Automated Breast Ultrasound

Completed

Conditions studied: Breast Cancer

In brief

The investigators are interested in assessing the value of and comparing the use of automated breast ultrasound (ABUS) (either as a primary screening approach or as a supplementary procedure) with digital breast tomosynthesis (DBT). The purpose of this project is to perform a preliminary prospective study on women who are most likely to benefit from the use of ABUS and/or DBT (or a combination of both) in the screening environment.

Key facts

Study ID

NCT02386176

Run by

University of Pittsburgh

People needed

598

Starts

2015-08-01

Expected to finish

2020-03-01

Last updated by the study team

2020-04-06

Who can join

Age: 40 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 40 to 75 years of age with a
• defined region of extremely dense breast tissue or 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 breast cancer susceptibility gene (BRCA) (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 at the time of screening by self report or lactation within the prior 6 months;
• 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;
• Had prior screening with DBT and not a hand held ABUS, or had prior screening with ABUS and not DBT.
• Prior malignancy other than: 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 Basal or squamous cell skin cancer or in situ cervical cancer, or 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
• Unwilling or unable to provide consent.

Where it is running

• 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.