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

NCT07273565 | Enrolling By Invitation DMC

• 1 other identifier: HREBA.CC-25-0255
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.Can the distribution of electrical properties specifically glandular tissue distribution in the microwave image be compared to that observed in the mammogram?
3. 3.Can the characteristics of the microwave image in the localized region corresponding to an identified anomaly in the mammogram be examined?

Conditions

Breast - Female

Keywords

women; mammography; recall; breast

Outcome Measures

Primary Outcomes (1)

• Measurement of electrical properties of breast tissues in microwave images

  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 Outcomes (5)

• Examine the similarity in plate separation between mammography and Wave View scans

  12 months

• Breast area

  12 months

• Examine the similarity between glandular tissue distribution on mammograms and electrical property images obtained with the Wave View scanner.

  12 months

• Examine how closely the presence of responses in Wave View scans correspond to anomalies detected on mammograms

  12 months

• Estimate of breast composition

  12 months

Study Arms (1)

WVI-MIS-02-2025

EXPERIMENTAL

A single arm study in which the collected microwave data is compared against available clinical data.

Device: WVI-MIS-02-2025

Interventions

WVI-MIS-02-2025 DEVICE

Microwave scans

WVI-MIS-02-2025

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female sex
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Pureform Radiology: collaborator
• Wave View Imaging Inc.: collaborator

Study Sites (1)

Pureform Radiology

Calgary, Canada

Location

Related Publications (6)

• C. M. Butterworth, P. Mojabi, and E. C. Fear, "Quantifying Consistency of Microwave Breast Imaging: Laser Scanning for Assessing Breast Volume and Shape," IEEE Journal of Electromagnetics, RF and Microwaves in Medicine and Biology, pp. 1-9, 2025, doi: 10.1109/JERM.2025.3531693

  RESULT

• Mojabi P, Bourqui J, Lasemiimeni Z, Grewal B, Fear E. Microwave Imaging for Breast Cancer Detection: Performance Assessment of a Next-Generation Transmission System. IEEE Trans Biomed Eng. 2025 Jun;72(6):1787-1799. doi: 10.1109/TBME.2024.3521410.

  PMID: 40031671 RESULT

• Wang Z, Mojabi P, Price S, Lasemiimeni Z, Besler B, Bourqui J, Deutscher D, Besler B, Shen H, Docktor B, Tsang RY, Fear E. Reproducibility of Microwave Breast Imaging: Analysis of Regular Scans of a Group of Volunteers. IEEE Trans Biomed Eng. 2025 May;72(5):1562-1571. doi: 10.1109/TBME.2024.3512572. Epub 2025 Apr 22.

  PMID: 40030750 RESULT

• Mojabi P, Bourqui J, Fear E. Fast 3D Breast Imaging With a Transmission-Based Microwave System. IEEE Trans Med Imaging. 2025 May;44(5):2206-2217. doi: 10.1109/TMI.2025.3527916. Epub 2025 May 2.

  PMID: 40030952 RESULT

• 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.

  PMID: 37800880 RESULT

• 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. . : . .

  RESULT

Study Design

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

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 9, 2025
• Study Start: March 19, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)