Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection

NCT04253366 | Completed

• 1 other identifier: DE-17-17
• Study Type: interventional
• Target: 353
• Locations: 2 countries
• Sites: 3

Brief Summary

This is a multicentric, single arm, prospective, stratified by breast density clinical investigation using Mammowave that is a device, which uses microwaves instead of ionizing radiation (X-ray)for breast lesions(BL) detection. Specifically, Mammowave employs a novel technique which generates images by processing very low power (\<1 mW) microwaves. The exam takes few minutes per breast and is performed with the patient lying in a comfortable 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 (against Reference Standard)

  During the baseline

• Percentage of correct BL localization in terms of quadrant (against Reference Standard)

  During the baseline

• Absolute and rate agreement between different evaluator (i.e. local radiologist versus central)

  Through study completion, an average of 1 year

• Sensitivity for each breast density group

  During the baseline

• Sensitivity for patients which had recent mammography

  During the baseline

Study Arms (1)

Single arm

OTHER

All patients perform standard breast screening and also MammoWave exam.

Device: Clinical investigation device class IIa not marked CE

Interventions

Clinical investigation device class IIa not 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 will be ready for the MammoWave exam. The exam will be composed of two phases: the data acquisition and the data processing. During the acquisition that should 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+
• Gender Eligibility Details: Women in order to performe breast screening
• 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 conventional exams (such as breast specialist visit and mammography and/or ultrasound and/or magnetic resonance imaging) within the last month.
• Patients willing to comply with study protocol and recommendations.
• Patients with intact breast skin (i.e. without bleeding lesion, scar).

You may not qualify if:

• Patients that are enrolled in another clinical study
• Patients who belong to any vulnerable group.
• Patients with implanted electronics.
• Patients who have undergone biopsy less than one week before MammoWave scan
• Patients with breast implants
• Patients with nipple piercings (unless they are removed before MammoWave exam).
• Participation in other studies in the last month before screening
• Pregnancy or breastfeeding

Sponsors & Collaborators

• Umbria Bioengineering Technologies: lead

Study Sites (3)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliera Universitaria S. Martino Di Genova

Genova, 16132, Italy

Location

Hospital Virgen de la Salud

Toledo, 16132, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

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

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: February 5, 2020
• Study Start: September 16, 2020
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); ES (1)