Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer (mp-BUS)

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Breast Cancer

Treatments: Device: mp-BUS data collection

Study type: Interventional

Funder types: Other

Identifiers

NCT04480437

2020-01-mp-BUS

Details and patient eligibility

About

It is studied whether multi-parametric biomarkers such as speed-of-sound imaging or others, applied during breast ultrasound (BUS) imaging allows to classify lesions according to its malignancy. The standard reference intervention is BUS guided biopsy or the consensus of the board of experts judging the BUS imaging results if no biopsy is done.

Full description

Patients with a palpable lump in the breast or suspicious findings in X-ray mammography typically undergo breast ultrasound examination as a supplemental imaging modality. Findings are then used for tumour classification according the American Collage of Radiology (ACR) Breast Imaging Reporting and Database System (BI-RADS) lexicon. Suspicious findings then undergo ultrasound-guided biopsy, which causes discomfort for the patient and introduces high emotional stress, and may involve - albeit very-small - risk of complications (such as bleeding and infections).

Today conventional breast ultrasound B-mode images do not have the specificity to reliably differentiate malignant and benign tissues in all cases and hence a biopsy intervention or close follow-up is necessitated. Multiparametric imaging bio-markers such as the novel method of speed-of-sound imaging may provide additional indicators to help to better classify lesions prior to biopsy and avoid any further work-up.

The study collects data with an ultrasound device during normal BUS examination which is then retrospectively processed to extract the desired multi-parametric BUS (mp-BUS) information of imaged tissue.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women who are suspected or suspected of having breast cancer and who are advised to perform a detailed breast ultrasound or tissue sampling (biopsy)

• Classification into groups:

  • Group 1: Foreseen for BUS guided biopsy
  • Group 2: BI-RADS classification I, II and III and foreseen for BUS only based diagnosis

Exclusion criteria

• Lactating women
• Women with mastitis
• Vulnerable persons

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Study Intervention

Experimental group

Description:

mp-BUS data collection

Treatment:

Device: mp-BUS data collection