Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer (mp-BUS)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
mp-BUS data collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Kantonsspital Baden
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Intervention
Arm Description
mp-BUS data collection
Outcomes
Primary Outcome Measures
Speed-of-sound imaging shows malignancy of lesion
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04480437
First Posted
July 16, 2020
Last Updated
December 27, 2021
Sponsor
Swiss Federal Institute of Technology
Collaborators
Kantonsspital Baden
1. Study Identification
Unique Protocol Identification Number
NCT04480437
Brief Title
Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer
Acronym
mp-BUS
Official Title
Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
December 13, 2021 (Actual)
Study Completion Date
December 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
Kantonsspital Baden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Intervention
Arm Type
Experimental
Arm Description
mp-BUS data collection
Intervention Type
Device
Intervention Name(s)
mp-BUS data collection
Intervention Description
Collect ultrasound raw data and B-mode images of all kind of breast lesions to external storage device.
Primary Outcome Measure Information:
Title
Speed-of-sound imaging shows malignancy of lesion
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kubik Rahel, Prof. Dr.
Organizational Affiliation
Kantonsspital Baden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multi-parametric Breast Ultrasound Imaging as a Potential Biomarker for Breast Cancer
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