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

December 27, 2021 updated by: Swiss Federal Institute of Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Baden, Switzerland, 5404
        • Kantonsspital Baden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

Kantonsspital Baden

Investigators

  • Principal Investigator: Kubik Rahel, Prof. Dr., Kantonsspital Baden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2020

Primary Completion (ACTUAL)

December 13, 2021

Study Completion (ACTUAL)

December 13, 2021

Study Registration Dates

First Submitted

July 16, 2020

First Submitted That Met QC Criteria

July 16, 2020

First Posted (ACTUAL)

July 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 28, 2021

Last Update Submitted That Met QC Criteria

December 27, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01-mp-BUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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