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Completed

NCT Number: NCT04253366

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

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.

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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

Istituto Clinico Humanitas, Rozzano, Milano, Italy

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About this study

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.

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 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).

Exclusion criteria

  • 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

Treatment and study plan

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.

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 (against Reference Standard)

    Time frame: During the baseline

    MammoWave specificity and sensitivity (against Reference Standard like Mammography, MRI and/or Echography)

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

    Time frame: During the baseline

    Percentage of correct BL localization in terms of quadrant comparing to Reference Standard like Mammography, MRI and/or Echography

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

    Time frame: 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.

  4. Sensitivity for each breast density group

    Time frame: During the baseline

    Sensitivity of MammoWave according to different types of breast density groups

  5. Sensitivity for patients which had recent mammography

    Time frame: During the baseline

    Sensitivity for patients which had performed recently mammography exam.

  6. Patient satisfaction questionnaire.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Umbria Bioengineering Technologies

Industry

Registry information

Official study title

A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection

Acronym: DE-17-17

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Aug 24, 2021

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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