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

NCT05300464 | Recruiting

• 1 other identifier: UBT 2022-01
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 3

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• MammoWave sensitivity (number of 'true positive' results)

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

  During the procedure

Secondary Outcomes (6)

• MammoWave specificity and sensitivity

  During the baseline

• Sensitivity for each breast density group

  During the baseline

• Sensitivity for patients which had recent mammography

  During the baseline

• Patient satisfaction questionnaire

  During the baseline

• MammoWave sensitivity in BC

  During the baseline)

Study Arms (1)

Single arm

OTHER

All patients perform standard breast screening and also MammoWave exam.

Device: Clinical investigation medical device class IIa marked CE

Interventions

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.

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umbria Bioengineering Technologies: lead

Study Sites (3)

IRCCS Policlinico San Martino

Genova, Genova, 16132, Italy

RECRUITING

Ospedale San Giovanni Battista - USL Umbria 2

Foligno, Perugia, 06034, Italy

NOT YET RECRUITING

Hospital Universitario de Toledo

Toledo, Spain, 45007, Spain

RECRUITING

Related Publications (1)

• Alvarez Sanchez-Bayuela D, Ghavami N, Romero Castellano C, Bigotti A, Badia M, Papini L, Raspa G, Palomba G, Ghavami M, Loretoni R, Calabrese M, Tagliafico A, Tiberi G. A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Confirm MammoWave's Ability in Breast Lesions Detection. Diagnostics (Basel). 2023 Jun 17;13(12):2100. doi: 10.3390/diagnostics13122100.

  PMID: 37370995 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Gianluigi Tiberi

CONTACT

0039 34900564302; gianluigi@ubt-tech.com

Sabatino Tiberi

CONTACT

s.tiberi@ubt-tech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Clinical investigation with Medical Device class IIa marked CE

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: January 7, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); ES (1)