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

Study Overview
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Brief Summary
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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
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This study aims to enrol approximately 103 subjects presenting to the symptomatic breast unit with a breast abnormality who consent to undergo an MBI 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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Wavelia #2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: All patients will have an MBI scan with Wavelia in addition to standard of care procedures
Masking: None (Open Label)


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.<br>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<br>* 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 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.<br>|

What is the study measuring?
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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 MBI | Duration of study - 19 months | 
| Assess the potential for differentiation between malignant and benign breast lesions, using Wavelia MBI. | Endpoint: Proportion of benign and malignant breast lesions correctly classified with Wavelia MBI | Duration of study - 19 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess lesion sizing for patients who have undergone surgery post MBI scan and for whom post-surgery histology data is available. | Endpoint: Maximal linear size difference (in mm) between the MBI lesion detection and the maximal size being reported in the post-surgery histological analysis of the excised tumour. | Duration of study - 19 months | 
| Assess the potential for differentiation between ILC and IDC cancer types, or other cancer types (if sufficient data is available) using Wavelia MBI. | Endpoint: Percentage of cancers correctly classified per cancer type with Wavelia MBI (e.g. ILC, IDC, other). | Duration of study - 19 months |