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

NCT04480437 | Completed DMC

• 1 other identifier: 2020-01-mp-BUS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Study Arms (1)

Study Intervention

EXPERIMENTAL

mp-BUS data collection

Device: mp-BUS data collection

Interventions

mp-BUS data collection DEVICE

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

Study Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Lactating women
• Women with mastitis
• Vulnerable persons

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Kantonsspital Baden: collaborator

Study Sites (1)

Kantonsspital Baden

Baden, 5404, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kubik Rahel, Prof. Dr.

  Kantonsspital Baden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed trial is designed as an explorative, open label, non-randomised, uncontrolled clinical trial.

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: November 15, 2020
• Primary Completion: December 13, 2021
• Study Completion: December 13, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)