NCT06157879

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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

November 6, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

May 27, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2024

Completed
Last Updated

October 8, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

November 6, 2023

Last Update Submit

October 2, 2025

Conditions

Keywords

women

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlation between the electrical properties of breast tissue and breast density

    18 months

Study Arms (1)

WVI-MIS-01-2022

EXPERIMENTAL

Healthy volunteers

Device: WVI-MIS-01-2022

Interventions

Microwave scans

WVI-MIS-01-2022

Eligibility Criteria

Age18 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, Canada

Location

Related Publications (2)

  • 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
  • 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: 37800880BACKGROUND

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 6, 2023

First Posted

December 6, 2023

Study Start

May 27, 2024

Primary Completion

November 18, 2024

Study Completion

November 18, 2024

Last Updated

October 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations