Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection

Open-label,Single Site,Pilot Clinical Investigation to Assess Detectability and Sizing of Invasive Breast Cancers,Detectability of Benign Breast Lesions,Differentiation Between Malignant and Benign Breast Lesions Using Wavelia # 2

The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.

Microwave imaging is an emerging imaging modality for the early detection of breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at the microwave frequency spectrum.

This study is a pilot Clinical Evaluation of a microwave imaging system (Wavelia #2) for Breast Cancer Detection. The clinical data that will be collected in the context of this study is intended for the assessment of the imaging diagnostic capability and the safety of the investigational device.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Wavelia #2

Detailed Description

This study aims to enrol approximately 103 subjects presenting to the symptomatic breast unit with a breast abnormality who consent to undergo an Microwave Breast Imaging (MWBI) scan using the Wavelia #2 imaging system. The study uses an adaptive design to verify and validate the technical evolutions that have been integrated in the Wavelia# 2 prototype on a small patient dataset (30 patients). Once the technical performance has been established recruitment will continue to assess the clinical performance of the MBI system compared to standard of care reference imaging. The primary objectives of the study are to assess the performance of Wavelia # 2 in the detection of malignant and benign breast lesions, the sizing of malignant lesions for which post-surgery histology data will be available and the differentiation between benign and malignant breast abnormalities by means of features extracted from the MBI images.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland
    • Galway University Hospital/Symptomatic Breast Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Informed Consent
• Female subjects with an investigator assessed discrete breast abnormality of size > 1cm
• Able and willing to comply with the requirements of this study protocol
• Negative urine pregnancy test on the day of microwave imaging procedure (if of childbearing potential)
• intact breast skin (i.e., without bleeding lesion, no evidence of inflammation and/or erythema of the breast)
• Able to comfortably lie reasonably still in a prone position for approximately 15 minutes
• Have had biopsy more than 2 weeks prior to the microwave breast investigation (if applicable)

Exclusion Criteria:

• Have a cup size of A or whose breast is deemed too small to allow MBI assessment in the opinion of the investigator
• Are pregnant or breast-feeding
• Have had surgery on either breast within the past 12 months
• Have any active or metallic implant other than a biopsy clip
• Would be unsuitable for an MBI scan or unlikely to follow the protocol in the opinion of the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• 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: All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging.; Patients with an investigator assessed discrete breast abnormality of size >1cm and who attend the symptomatic breast unit for assessment as per standard of care protocol will be considered for participation in this clinical investigation.

Device: Wavelia #2; Patients who are eligible and consent to have an MBI breast scan procedure will be asked to confirm their willingness to participate on the day of the breast scan. The patient will first have an Optical Breast Contour Detection (OBCD) scan, to reconstruct the external surface of the breast with high-precision, measure the total volume and the vertical extent of the breast before the MBI scan. The MBI scan will be performed on both breasts. The process will include optimization of breast positioning and breast cleaning to remove any transition liquid remaining on the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the Detectability Rate of Malignant and Benign Breast Lesions.	Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correct Sizing of Breast Lesions With Wavelia MWBI	Endpoint: Maximal linear size difference (in mm) between the MWBI lesion detection and the maximal size reported in the ultrasound lesion size estimates. This is measured as a continuous variable of difference in mm	21 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the Wavelia MWBI Breast Lesion Detectability Rate on Patients With no Biopsy Clip	Endpoint: Percentage of breast lesions correctly detected with Wavelia MWBI on patients with no biopsy clip marking in their breast	21 days
Safety Objective: Provide Further Data to Support the Establishment of the Safety Profile of MWBI Scan	Endpoint: Incidence of Serious Adverse Events and Serious Adverse Device Effects during the total duration of the trial as well as other adverse events reported.	21 days

Collaborators and Investigators

• Sponsor: MVG Industries SAS
• Investigators: Principal Investigator: Michael Kerin, Galway University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): June 13, 2024
• Study Completion (Actual): October 4, 2024

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: March 3, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: TP.102.17.22.PAR

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