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

May 12, 2026 updated by: Umbria Bioengineering Technologies

A Clinical Investigation (Multicentric, Single Arm, Prospective, Stratified) to Confirm the Ability of MammoWave (Microwave Mammogram) in Breast Lesions Detection

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Trieste, Italy, 34128
    • Genova
      • Genova, Genova, Italy, 16132
    • Perugia
      • Foligno, Perugia, Italy, 06034
        • Recruiting
        • Ospedale San Giovanni Battista - USL Umbria 2
        • Contact:
          • Riccardo LORETONI
          • Phone Number: 0742/3397116
  • Spain
    • Spain
      • Toledo, Spain, Spain, 45007
        • Recruiting
        • Hospital Universitario de Toledo
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm
All patients perform standard breast screening and also MammoWave exam.
Device: Clinical investigation medical device class IIa marked CE
Patients should perform MammoWave exam. A short visit should be performed and during this visit a qualitative differentiation would be performed between patients with high density breast, and patients with low density breast. After the patients are ready for MammoWave exam. The exam will composed of two phases: the acquisition and data processing. During the acquisition that sholud takes about 10 minutes the patients would be lying in a prone position, on a bed which is part of the MammoWave. The upper part of MammoWave has a container cup shape, which contains the breast, which also has the function of separate it from the internal parts of the device. After patient is on the bed and MammoWave would start to perform the acquisition. Once the acquisition is completed, the data will be processed through an imaging algorithm, which is integrated in the device. The final output will be composed by one or more images, plus one or more parameters describing the images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MammoWave sensitivity (number of 'true positive' results)
Time Frame: During the procedure
MammoWave sensitivity (number of 'true positive' results) compared to Reference Standard
During the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity for each breast density group
Time Frame: During the baseline
Sensitivity of MammoWave according to different types of breast density groups
During the baseline
MammoWave specificity and sensitivity
Time Frame: During the baseline
MammoWave specificity and sensitivity (against Reference Standard)
During the baseline
Sensitivity for patients which had recent mammography
Time Frame: During the baseline
Sensitivity for patients which had performed recently mammography exam
During the baseline
Patient satisfaction questionnaire
Time Frame: During the baseline
Patient satisfaction questionnaire output according to their experience performing
During the baseline
MammoWave sensitivity in BC
Time Frame: During the baseline)
Sensitivity of MammoWave in Breast Cancer detection (against reference standard)
During the baseline)
MammoWave specificity and sensitivity using RadioSpin simulator
Time Frame: 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)
During the Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umbria Bioengineering Technologies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 18, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBT 2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Clinical investigation medical device class IIa marked CE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe