A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection

Not Applicable

Recruiting

• Conditions: Breast Cancer
• Interventions: Device: Clinical investigation medical device class IIa marked CE

• Registration Number: NCT05300464
• Lead Sponsor: Umbria Bioengineering Technologies

Brief Summary

This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions.

MammoWave is a innovative medical device, class IIa marked CE, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. Specifically MammoWave employs a novel technique wich generates images by processing very low power (\<1mW) microwave.

The MammoWave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position.

MammoWave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times.

Detailed Description

The maximum number of participants to the clinical investigation will be 600 (for all the sites). The study will be composed of two phases: a preliminary phase to 'optimize the imaging algorithm for each apparatus installed at each centre', where 15 volunteers (in each centre) having breast with no lesions (NL) will be examined by MammoWave. In the second phase, the remaining people will be enrolled (BL will be 50% of total) and examined by MammoWave by the clinical investigator, and results will be compared with the effective diagnosis already obtained by standard clinical methods. BL includes malignant lesions (BC) and benign lesions, and may be palpable or non-palpable lesions. BL includes also isolated clustered microcalcifications.

The primary gol of the clinical study is to assess MammoWave's ability in BL detection.

The study will involve investigational sites in Italy, Germany and Spain.

Study Timeline

• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-29
• Study Start: 2023-01-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2026-09-30
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Signed Informed consent Form
• Women
• Adult ≥ 18 years old
• Having a radiologist study output obtained using mammography within the last month. Such radiologist study output may be integrated with ultrasound and /or magnetic resonance imaging output if deemed necessary by the responsible investigator and when available. The radiological output will be integrated with histological one if deemed necessary by the responsible investigator and when available.
• Patients willing to comply with study protocol and recommendations

Exclusion Criteria

• Patients who belong to any vulnerable group
• Patients with implanted electronic devices
• Patients who have undergone biopsy less than one week before MammoWave scan
• Patients with nipple piercings (unless they are removed prior to examination)
• Pregnancy or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Clinical investigation medical device class IIa marked CE	All patients perform standard breast screening and also MammoWave exam.

Primary Outcome Measures

Name	Time	Method
MammoWave sensitivity (number of 'true positive' results)	During the procedure	MammoWave sensitivity (number of 'true positive' results) compared to Reference Standard

Secondary Outcome Measures

Name	Time	Method
Sensitivity for each breast density group	During the baseline	Sensitivity of MammoWave according to different types of breast density groups
MammoWave specificity and sensitivity using RadioSpin simulator	During the Baseline	Specificity and sensitivity of MammoWave (against Reference Standard) when retrospectively using MammoWave data in one RadioSpin technology simulator / Artificial Intelligence (AI) algorithms. NOTE: RadioSpin (Deep oscillatory neural networks computing and learning through the dynamics of RF neurons interconnected by RF spintronic synapses) is one of the projects funded by EU within the call FUTURE EMERGING TECHNOLOGIES (FET) H2020-FETPROACT. The RadioSpin project aims to build a hardware neural network, as a "Hardware Artificial Intelligence" will be implemented. During the project, these hardware neural networks will be optimized and tested on MammoWave data, being UBT partner of RadioSpin consortium (Grant agreement ID: 101017098)
MammoWave specificity and sensitivity	During the baseline	MammoWave specificity and sensitivity (against Reference Standard)
Sensitivity for patients which had recent mammography	During the baseline	Sensitivity for patients which had performed recently mammography exam
MammoWave sensitivity in BC	During the baseline)	Sensitivity of MammoWave in Breast Cancer detection (against reference standard)
Patient satisfaction questionnaire	During the baseline	Patient satisfaction questionnaire output according to their experience performing

Trial Locations

Locations (3)

IRCCS Policlinico San Martino; 🇮🇹 Genova, Italy

Hospital Universitario de Toledo; 🇪🇸 Toledo, Spain

Ospedale San Giovanni Battista - USL Umbria 2; 🇮🇹 Foligno, Perugia, Italy