Last updated on October 2018

Diagnostic Performance of an Automated Breast Ultrasound System (ABUS)

Brief description of study

The purpose of this study is to evaluate the diagnostic performance of a new ABUS system among 4 different population:

Population A: women undergoing screening for familial or genetic predisposition for breast cancer.

Population B: women with newly diagnosed breast cancer. ABUS performance will be compared to breast MRI in the pre-operative assessment of breast cancer extent.

Population C: women with BI-RADS 3 or 4 lesions in a routine breast imaging examination. ABUS will be evaluate as a problem-solving tool.

Population D: women undergoing breast MRI for the assessment of breast implants integrity. ABUS performance will be compared to breast MRI.

Detailed Study Description

Population A: women in the age range of 20 to 40 years, with a strong family history of breast cancer or a predisposing gene mutation such as BRCA1 or BRCA2. A total of 100 patients should be enrolled.

Population B: women with new breast cancer diagnosis undergoing pre-operative local cancer staging.A total of 50 patients will be enrolled.

Population C: women with lesions classified BI-RADS 3 or 4 in a routine breast imaging examination. A total of 50 patients will be enrolled.

Population D: women undergoing breast-MRI for the evaluation of breast implants integrity. A total of 50 patients will be enrolled.

The expected duration of subject participation is 5 years for population A: every year the patients will undergo ABUS examination and the results will be compared with HHUS examination.

In population B, C and D only one examination will be performed and the data obtained with ABUS will be compared with HH-US and breast MRI data.

Images will be evaluated by a radiologist with breast imaging experience and ABUS findings will be compared with findings from HHUS and MR imaging.

Afterwards, two or three readers (radiologists with different levels of experience in breast imaging) blinded to clinical, HH-US and MRI data, will evaluate the interobserver agreement ABUS images will be evaluated by Methods of minimising bias Population A - During the recruitment, family history of breast cancer will be in-depth analysed in order to avoid the bias related to different levels of risk for breast cancer. In order to reduce the loss of patients to follow-up, women will be invited every year to undergo HHUS and ABUS examination at our department.

Clinical Study Identifier: NCT02661204

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Recruitment Status: Open

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