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

NCT05757427 | Completed Results

• 1 other identifier: TP.102.17.22.PAR
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correct Sizing of Breast Lesions With Wavelia MWBI

  21 days

Other Outcomes (2)

• Evaluate the Wavelia MWBI Breast Lesion Detectability Rate on Patients With no Biopsy Clip

  21 days

• Safety Objective: Provide Further Data to Support the Establishment of the Safety Profile of MWBI Scan

  21 days

Study Arms (1)

All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging.

EXPERIMENTAL

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

Interventions

Wavelia #2 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.

All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• MVG Industries SAS: lead

Study Sites (1)

Galway University Hospital/Symptomatic Breast Unit

Galway, Ireland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Luc Duchesne
• Organization: MVG Industries SAS

luc.duchesne91@gmail.com

+33 (0) 6 70 33 91 20

Study Officials

• Michael Kerin

  Galway University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Model Details: All patients will have an MBI scan with Wavelia in addition to standard of care procedures

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 7, 2023
• Study Start: March 9, 2023
• Primary Completion: June 13, 2024
• Study Completion: October 4, 2024
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)