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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Clinical investigation device class IIa not marked CE

• Registration Number: NCT04253366
• Lead Sponsor: Umbria Bioengineering Technologies

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.

Detailed Description

The number of participants will be 500 (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 healthy volunteers in each centre will be examined by MammoWave. In the second phase, the remaining people will be enrolled (Breast Lesions pts will be about 70% 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.

At the end of the study, in each centre the clinical investigators will compare MammoWave output against the radiologist study output obtained using conventional exams.

In addition, at the end of the study, the MammoWave output will be centrally reviewed in blind by an independent radiologist in order to confirm the data and confirm centrally the comparisons performed locally. The primary goal of the clinical study is to assess Mammowave's ability in BL detection and differentiation.

Study Timeline

• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Study Start: 2020-09-16
• Status Verified: 2021-08
• Primary Completion: 2021-08-20
• Study Completion: 2021-08-20
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 353

Inclusion Criteria

1. Signed Informed consent Form
2. Women
3. Adult ≥18 years old
4. 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.
5. Patients willing to comply with study protocol and recommendations.
6. Patients with intact breast skin (i.e. without bleeding lesion, scar).

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Clinical investigation device class IIa not 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
MammoWave specificity and sensitivity (against Reference Standard)	During the baseline	MammoWave specificity and sensitivity (against Reference Standard like Mammography, MRI and/or Echography)
Absolute and rate agreement between different evaluator (i.e. local radiologist versus central)	Through study completion, an average of 1 year	Absolute and rate agreement between different evaluator local radiologist versus central, in order to avoid mistakes in the MammoWave output.
Sensitivity for each breast density group	During the baseline	Sensitivity of MammoWave according to different types of breast density groups
Patient satisfaction questionnaire.	During the baseline	Patient satisfaction questionnaire output according to their experience performing MammoWave test based on 12 questions: n° 2 "Multiple Choice questions"; YES, NO, explain (with open-ended text area) regarding: * The effective execution of MammoWave; * The willing to promote MammoWave; n° 5 "5 point Numeric Rating scale" ranging from 1 to 5 (1=Not at all, 5= A lot) regarding the subjective evaluation of MammoWave.; n° 5 "3 point Numeric Rating scale" ranging from 1 to 3 (1=less, 3= more) regarding the comparative evaluation of MammoWave vs Conventional tests (Mammography, Ultrasound, Magnetic Resonance Imaging).
Sensitivity for patients which had recent mammography	During the baseline	Sensitivity for patients which had performed recently mammography exam.
Percentage of correct BL localization in terms of quadrant (against Reference Standard)	During the baseline	Percentage of correct BL localization in terms of quadrant comparing to Reference Standard like Mammography, MRI and/or Echography

Trial Locations

Locations (3)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Azienda Ospedaliera Universitaria S. Martino Di Genova; 🇮🇹 Genova, Italy