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

Sponsor
Swiss Federal Institute of Technology (Other)
Overall Status
Completed
CT.gov ID
NCT04480437
Collaborator
Kantonsspital Baden (Other)
100
Enrollment
1
Location
1
Arm
12.9
Actual Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: mp-BUS data collection
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer
Actual Study Start Date :
Nov 15, 2020
Actual Primary Completion Date :
Dec 13, 2021
Actual Study Completion Date :
Dec 13, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kantonsspital Baden Baden Switzerland 5404

Sponsors and Collaborators

  • Swiss Federal Institute of Technology
  • Kantonsspital Baden

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT04480437
Other Study ID Numbers:
  • 2020-01-mp-BUS
First Posted:
Jul 21, 2020
Last Update Posted:
Dec 28, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Dec 28, 2021