Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: mp-BUS data collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Intervention<br>mp-BUS data collection | Device: mp-BUS data collection<br>* Collect ultrasound raw data and B-mode images of all kind of breast lesions to external storage device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed-of-sound imaging shows malignancy of lesion | Evaluate the non-inferiority or superiority of the multi-parametric method compared to the standard ultrasound technique, using BUS guided biopsy as gold standard, to determine the malignancy of a lesion in woman breast. | 6 months |