Measuring Electrical Properties of Breast Tissues

The goal of this observational study is to use a low-powered microwave imaging system to provide insight into the correlation of electrical properties of breast tissue at microwave frequencies and breast density obtained from mammograms in healthy women between the ages of 18 and 74. The main questions it aims to answer : • Is there a correlation between the electrical properties of breast tissue and breast density obtained from mammograms? Both breasts of each participant will be scanned by the microwave imaging system six times in total.

Study Overview

• Status: Completed
• Conditions: Healthy; Breast
• Intervention / Treatment: Device: WVI-MIS-01-2022

Detailed Description

A new approach to imaging that uses low-power microwaves to scan the breast has been developed. Since the imaging system uses low power, there is no risk of tissue heating. The imaging system places the sensors in contact with the breast and does not require compression. The research team at the University of Calgary has previously developed microwave imaging systems that have been tested on volunteers and patients. This included repeated scanning of a group of volunteers to evaluate the consistency of the approach. The information collected from experiences scanning volunteers and patients have been reviewed and translated into a next-generation imaging system design. Aspects of this system have been further improved by Wave View Imaging, which is a company formed by members of the University's research team.

The proposed study involves collecting electrical property measurements of breast tissues and comparing these measurements to clinical information. The investigators also aim to compare regions of interest in the microwave scans with regions of interest in the mammograms. This includes regions dominated by fibroglandular tissues, as well as regions of interest that correspond to anomalies identified in the mammograms

The plan is to scan both breasts of up to 200 volunteers. Each volunteer will participate in a single scanning session. Breast tissue composition (VOLPARA score) will be compared with the microwave properties and registration of mammograms with microwave images will be performed for a more detailed comparison.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Must have had a previous mammogram in the last 2 years

Exclusion Criteria:

• Participants currently undergoing chemotherapy and/or radiation treatment.
• Participants with breast implants.
• Participants who are breast or breastfeeding.
• Participants with active breast infections.
• Participants with nipple piercings (unless they can be removed prior to scanning).
• Participants with an implanted electronic device.
• Participants with physical limitations that prevent them from placing their breasts in the scanner.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WVI-MIS-01-2022; Healthy volunteers	Device: WVI-MIS-01-2022; Microwave scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of electrical properties of breast tissue	The electrical properties will be estimated for each volunteer and an image that maps these properties will be created.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between the electrical properties of breast tissue and breast density	Comparison of the microwave images and mammograms in 2 ways: VOLPARA scores versus average electrical properties and comparison of regions of interest in both images	18 months

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Alberta Innovates Health Solutions; Wave View Imaging

Publications and helpful links

General Publications

• Smith, K., et al. "Microwave Imaging of the Breast: Consistency of Measurements Over Time." IEEE Journal of Electromagnetics, RF and Microwaves in Medicine and Biology, vol. 6, no. 1, 2022, pp. 61-67, https://doi.org/10.1109/JERM.2021.3099014.
• Smith K, Bourqui J, Wang Z, Besler B, Lesiuk M, Roumeliotis M, Quirk S, Grendarova P, Pinilla J, Price S, Docktor B, Fear E. Microwave imaging for monitoring breast cancer treatment: A pilot study. Med Phys. 2023 Nov;50(11):7118-7129. doi: 10.1002/mp.16756. Epub 2023 Oct 6.

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Actual): November 18, 2024
• Study Completion (Actual): November 18, 2024

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: women
• Other Study ID Numbers: HREBA.CC-22-0112

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
• product manufactured in and exported from the U.S.: No