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

NCT ID: NCT04480437

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2021-12-13

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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Intervention

mp-BUS data collection

Group Type EXPERIMENTAL

mp-BUS data collection

Intervention Type DEVICE

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

Interventions

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mp-BUS data collection

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

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Baden

OTHER

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kubik Rahel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Baden

Locations

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Kantonsspital Baden

Baden, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2020-01-mp-BUS

Identifier Type: -

Identifier Source: org_study_id