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

Last updated: September 30, 2024
Sponsor: MVG Industries SAS
Overall Status: Completed

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Wavelia #2

Clinical Study ID

NCT05757427
TP.102.17.22.PAR
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 ofchildbearing potential)

  • intact breast skin (i.e., without bleeding lesion, no evidence of inflammationand/or erythema of the breast)

  • Able to comfortably lie reasonably still in a prone position for approximately 15minutes

  • Have had biopsy more than 2 weeks prior to the microwave breast investigation (ifapplicable)

Exclusion

Exclusion Criteria:

  • Have a cup size of A or whose breast is deemed too small to allow MBI assessment inthe 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 theopinion of the Investigator

Study Design

Total Participants: 73
Treatment Group(s): 1
Primary Treatment: Wavelia #2
Phase:
Study Start date:
March 09, 2023
Estimated Completion Date:
September 30, 2024

Study 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.

Connect with a study center

  • Galway University Hospital/Symptomatic Breast Unit

    Galway,
    Ireland

    Site Not Available

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