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

NCT ID: NCT05757427

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2024-10-04

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Wavelia #2

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MVG Industries SAS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Kerin

Role: PRINCIPAL_INVESTIGATOR

Galway University Hospital

Locations

Galway University Hospital/Symptomatic Breast Unit

Galway, , Ireland

Countries

Ireland

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TP.102.17.22.PAR

Identifier Type: -

Identifier Source: org_study_id