NCT07487792

Brief Summary

The goal of this clinical trial is to assess whether microwave scans can depict the presence of implants in the breast in women with existing breast implants that were surgically placed at least 6 months ago. The main questions it aims to answer are:

  1. 1.Can a microwave imaging device effectively scan a breast containing implants?
  2. 2.Can the presence of implants be identified in a microwave scan?
  3. 3.Can the microwave scans of the left and right breasts be compared to assess whether similarity is observed?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

June 25, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 17, 2026

Last Update Submit

June 23, 2026

Conditions

Breast - Female

Keywords

womenbreast implant

Outcome Measures

Primary Outcomes (1)

  • Measurement of regions of interest in microwave images

    Images of both breasts will be created. Regions of interest corresponding to the breast implants will be identified using the electrical properties. The size of these regions will be calculated.

    12 months

Secondary Outcomes (2)

  • Comparison of total area in implant in microwave image with known physical size

    12 months

  • Compare microwave scans of the left and right breast

    12 months

Study Arms (1)

A single arm study to determine feasibility of imaging breast implants

EXPERIMENTAL

WVI-MIS-03-2025

Device: WVI-MIS-03-2025

Interventions

WVI-MIS-03-2025DEVICE

Microwave scans

A single arm study to determine feasibility of imaging breast implants

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with breast implants placed at least 6 months prior who are asymptomatic for implant rupture as well as those with known implant rupture
  • Female
  • Minimum of 18 years of age
  • Able to provide informed consent

You may not qualify if:

  • Women who are currently pregnant or breastfeeding
  • Women with active breast infections
  • Women with nipple piercings (unless removed prior to scanning)
  • Women with implanted electronic device
  • Women with physical limitations that prevent them from placing their breasts inside the scanner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demsey Plastic Surgery Clinic

Calgary, Alberta, T3H 3K8, Canada

Location

Related Publications (6)

  • Mojabi P, Tsang RY, Docktor B, Deutscher D, Garland A, Mahsin M, Bourqui J, Fear E. Feasibility of tumor detection with a transmission-based microwave imaging system. Med Phys. 2025 Sep;52(9):e18080. doi: 10.1002/mp.18080.

    PMID: 40940299BACKGROUND

  • Mojabi P, Bourqui J, Docktor BJ, Tsang RY, Fear E. Assessment of Breast Composition With a Transmission-Based Microwave Imaging System. IEEE Trans Biomed Eng. 2026 Jan;73(1):451-461. doi: 10.1109/TBME.2025.3584669.

    PMID: 40587354BACKGROUND

  • Mojabi P, Tsang RY, Docktor BJ, Deutscher D, Garland A, Lasemiimeni Z, Bourqui J, Fear E. Point-of-Care Breast Imaging for Monitoring Neoadjuvant Treatment: Case Studies With Transmission-Based Microwave Imaging. IEEE Trans Biomed Eng. 2026 Mar;73(3):1181-1190. doi: 10.1109/TBME.2025.3599516.

    PMID: 40815587BACKGROUND

  • 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.

    BACKGROUND

  • Butterworth, Carina M., et al. "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, vol. 9, no. 3, 2025, pp. 335-43, https://doi.org/10.1109/JERM.2025.3531693.

    BACKGROUND

  • 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: 40031671BACKGROUND

Central Study Contacts

Anita Garland

CONTACT

403-703-1664anita.garland@ucalgary.ca

Elise Fear

CONTACT

403-210-5413fear@ucalgary.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 23, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

June 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)