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OpenTrials
Completed

NCT Number: NCT04480437

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kantonsspital Baden

Baden, 5404, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mp-BUS data collection

Device

Collect ultrasound raw data and B-mode images of all kind of breast lesions to external storage device.

Primary outcomes

  1. Speed-of-sound imaging shows malignancy of lesion

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Kantonsspital Baden

Registry information

Acronym: mp-BUS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 21, 2020
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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