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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05757427
• Other study ID #: TP.102.17.22.PAR
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2024
• Source: MVG Industries SAS
• Contact: Luc Duchesne
• Phone: +33 (0)1 69 29 81 56
• Email: luc.duchesne[@]mvg-world.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 103
• Est. completion date: November 30, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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 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.

Locations

Country	Name	City	State
Ireland	Galway University Hospital/Symptomatic Breast Unit	Galway

Sponsors (1)

Lead Sponsor	Collaborator
MVG Industries SAS

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate the Wavelia MBI breast lesion detectability rate (either malignant or benign) on patients with no biopsy clip, marking the lesion position in the breast.	Endpoint: Percentage of malignant and the percentage of benign breast lesions correctly detected with Wavelia MBI on pre-biopsy patients, with no biopsy clip in their breast will be represented by a binary variable which will be assigned the value of 1 if the lesion benign or malignant was detected by the device and 0 (zero) otherwise.	Duration of study - 19 months
Other	Safety objective: provide further data to support the establishment of the safety profile of the investigational medical imaging device and associated procedures	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.	Duration of study - 19 months
Primary	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
Primary	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	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
Secondary	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