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NCT Number: NCT05300464

A Clinical Investigation to Confirm the Ability of MammoWave 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Policlinico San Martino, Genova, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical investigation medical device class IIa marked CE

Device

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.

Primary outcomes

  1. MammoWave sensitivity (number of 'true positive' results)

    Time frame: During the procedure

    MammoWave sensitivity (number of 'true positive' results) compared to Reference Standard

Secondary outcomes

  1. MammoWave specificity and sensitivity

    Time frame: During the baseline

    MammoWave specificity and sensitivity (against Reference Standard)

  2. Sensitivity for each breast density group

    Time frame: During the baseline

    Sensitivity of MammoWave according to different types of breast density groups

  3. Sensitivity for patients which had recent mammography

    Time frame: During the baseline

    Sensitivity for patients which had performed recently mammography exam

  4. Patient satisfaction questionnaire

    Time frame: During the baseline

    Patient satisfaction questionnaire output according to their experience performing

  5. MammoWave sensitivity in BC

    Time frame: During the baseline)

    Sensitivity of MammoWave in Breast Cancer detection (against reference standard)

  6. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Gianluigi Tiberi

CONTACT

[email protected]

0039 34900564302

Sabatino Tiberi

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Umbria Bioengineering Technologies

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 29, 2022
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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