A Clinical Investigation (multicentric, Single Arm, Prospective, Stratified) to Confirm the Ability of MammoWave (microwave Mammogram) in Breast Lesions Detection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Umbria Bioengineering Technologies
- Enrollment
- 600
- Locations
- 3
- Primary Endpoint
- MammoWave sensitivity (number of 'true positive' results)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed Informed consent Form
- •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
Outcomes
Primary Outcomes
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
- Sensitivity for each breast density group(During the baseline)
- MammoWave specificity and sensitivity using RadioSpin simulator(During the Baseline)
- MammoWave specificity and sensitivity(During the baseline)
- Sensitivity for patients which had recent mammography(During the baseline)
- Patient satisfaction questionnaire(During the baseline)
- MammoWave sensitivity in BC(During the baseline))