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

Sponsor
MVG Industries SAS
Study ID
NCT05757427
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 9, 2023
Status verified
Oct 2025
Primary completion
Jun 13, 2024
Completion
Oct 4, 2024

Study Design

Enrollment
73 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

Assess the Detectability Rate of Malignant and Benign Breast Lesions. [ Time Frame: 21 days ]

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