Feasibility of Comparing Microwave Images and Mammograms in Patients Recalled for Follow-up Breast Imaging

March 20, 2026 updated by: University of Calgary

The goal of this clinical trial is to measure the electrical properties of breast tissues using microwave technology and to compare these collected measurements to clinical information in mammograms for women that have been recalled for follow-up breast imaging. The main questions it aims to answer are:

  1. Can the breast area and plate separation in the microwave scan be compared to mammogram data to assess similarity in breast positioning and the feasibility of image registration?
  2. Can the distribution of electrical properties specifically glandular tissue distribution in the microwave image be compared to that observed in the mammogram?
  3. Can the characteristics of the microwave image in the localized region corresponding to an identified anomaly in the mammogram be examined?

Study participants will be scanned with the Wave View microwave scanner on the same day as their follow-up breast imaging appointment. Each breast will be scanned up to 3 times with the scanner oriented in both the horizontal position and oriented at 45 degrees. Study participants will also be asked to fill out three surveys, one relating to breast health and the other two relating to their scanning experience.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 tissue. The research team at the University of Calgary has previously developed microwave imaging systems that have been tested on healthy volunteers and breast cancer patients. A group of healthy volunteers were repeatedly scanned to evaluate the consistency of the imaging approach. Another study involved scanning breast cancer patients before each round of neoadjuvant chemotherapy. 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 in mammograms. 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 20 volunteers that have been recalled for follow-up breast imaging. Each volunteer will participate in a single scanning session during their follow-up appointment. Breast tissue composition 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 (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Calgary, Canada
        • Pureform Radiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female sex
  • 18-74 years of age
  • Able to provide informed consent
  • Had a screening mammogram within the previous 6 weeks
  • Recalled for additional breast imaging due to BIRADS 3 or 4 findings.

Exclusion Criteria:

  • Participants who have not received a mammogram
  • Participants who are currently undergoing breast cancer treatment or have had treatment in the past 6 months
  • Participants with breast implants
  • Participants who are pregnant or breastfeeding
  • Participants with active breast skin infections
  • Participants with nipple piercings (unless they are removed prior to scanning)
  • Participants with an implanted electronic device
  • Participants with physical limitations that prevent them from placing their breasts inside the Wave View scanner.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WVI-MIS-02-2025
A single arm study in which the collected microwave data is compared against available clinical data.
Device: WVI-MIS-02-2025
Microwave scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of electrical properties of breast tissues in microwave images
Time Frame: 12 months
The average electrical properties of the Wave View image will be calculated (relative permittivity and attenuation). The average properties of the right and left breasts will be compared. The average properties of the craniocaudal (CC) and mediolateral oblique (MLO) views will also be compared for both breasts.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine the similarity in plate separation between mammography and Wave View scans
Time Frame: 12 months
The separation between the plates contacting the breast will be compared between the two modalities. This comparison provides an initial indication of the volume of breast tissue in the scanner.
12 months
Breast area
Time Frame: 12 months
The breast area on the mammogram will be compared to the breast area on the Wave View scan. The breast area in the Wave View image will be calculated, while the breast area on the mammogram is available from automated image analysis reports.
12 months
Examine the similarity between glandular tissue distribution on mammograms and electrical property images obtained with the Wave View scanner.
Time Frame: 12 months
The microwave image will be overlayed on the mammogram to provide initial insight on glandular tissue distribution via visual inspection. The images will be registered based on the outline of the breast. If the breast areas are found to differ, deformable registration techniques will be applied. Higher intensity regions representing glandular tissues will be identified in both images via image filtering and segmentation. These regions will be compared with metrics such as the Dice coefficient. In addition, the area of the higher intensity region will be compared with the overall area of the breast image, similar to the method used to calculate the percentages used in breast density analysis.
12 months
Examine how closely the presence of responses in Wave View scans correspond to anomalies detected on mammograms
Time Frame: 12 months
Localized regions in the Wave View image that correspond to locations of anomalies on the mammogram will be identified based on the registered images. The average properties of these regions will be compared with the average properties of a region in the same breast, as well as in the contralateral breast.
12 months
Estimate of breast composition
Time Frame: 12 months
Pureform Radiology uses a breast density tool to automatically calculate the volume of the breast and glandular tissue, as well as the percentage density and density category (A, B, C, D). Microwave properties are expected to be greater with greater breast densities.To compare electrical properties to breast density, average electrical properties of each microwave scan will be plotted against the corresponding percent density.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Pureform Radiology
Wave View Imaging Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HREBA.CC-25-0255

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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