Clinical trial NCT05300464: A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection
Official title: A Clinical Investigation (multicentric, Single Arm, Prospective, Stratified) to Confirm the Ability of MammoWave (microwave Mammogram) in Breast Lesions Detection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Umbria Bioengineering Technologies
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 600
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 marked CE
Primary purpose: SCREENING

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.

Detailed description: The maximum number of participants to the clinical investigation will be 600 (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 volunteers (in each centre) having breast with no lesions (NL) will be examined by MammoWave. In the second phase, the remaining people will be enrolled (BL will be 50% 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.

The primary gol of the clinical study is to assess MammoWave's ability in BL detection.

The study will involve investigational sites in Italy, Germany and Spain.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: MammoWave sensitivity (number of 'true positive' results)
timeFrame: During the procedure
Secondary outcomes:
measure: MammoWave specificity and sensitivity
timeFrame: During the baseline
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
measure: MammoWave sensitivity in BC
timeFrame: During the baseline)
measure: MammoWave specificity and sensitivity using RadioSpin simulator
timeFrame: During the Baseline
Other outcomes:
Locations:
city: Foligno
country: Italy
facility: Ospedale San Giovanni Battista - USL Umbria 2
state: Perugia
city: Genova
country: Italy
facility: IRCCS Policlinico San Martino
city: Toledo
country: Spain
facility: Hospital Universitario de Toledo
Study officials:
References: