Clinical trial NCT04253366: Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection
Official title: A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Evaluate the Ability of MammoWave in Breast Lesions Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Umbria Bioengineering Technologies
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 353
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical investigation with Medical Device class IIa
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: MammoWave sensitivity (number of 'true positive' results)
timeFrame: During the procedure
Secondary outcomes:
measure: MammoWave specificity and sensitivity (against Reference Standard)
timeFrame: During the baseline
measure: Percentage of correct BL localization in terms of quadrant (against Reference Standard)
timeFrame: During the baseline
measure: Absolute and rate agreement between different evaluator (i.e. local radiologist versus central)
timeFrame: Through study completion, an average of 1 year
measure: Sensitivity for each breast density group
timeFrame: During the baseline
measure: Sensitivity for patients which had recent mammography
timeFrame: During the baseline
measure: Patient satisfaction questionnaire.
timeFrame: During the baseline
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Genova
country: Italy
facility: Azienda Ospedaliera Universitaria S. Martino Di Genova
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
Study officials:
References: