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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: mp-BUS data collection

• Registration Number: NCT04480437
• Lead Sponsor: Swiss Federal Institute of Technology

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-21
• Study Start: 2020-11-15
• Status Verified: 2021-12
• Primary Completion: 2021-12-13
• Study Completion: 2021-12-13
• Last Update Submitted: 2021-12-27
• Last Update Posted: 2021-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Intervention	mp-BUS data collection	mp-BUS data collection

Primary Outcome Measures

Name	Time	Method
Speed-of-sound imaging shows malignancy of lesion	6 months	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.

Trial Locations

Locations (1)

Kantonsspital Baden; 🇨🇭 Baden, Switzerland