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

Overview

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.

Interventions

• Device Clinical investigation medical device class IIa marked CE
  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 are ready for MammoWave exam. The exam will composed of two phases: the acquisition and data processing. During the acquisition that sholud takes about 10 minutes the patients would be lying in a prone position, on a bed which is part of the MammoWave. Th

Primary outcome measures

• MammoWave sensitivity (number of 'true positive' results) [Time frame: During the procedure]

Secondary outcome measures (6)

• MammoWave specificity and sensitivity [Time frame: During the baseline]
• Sensitivity for each breast density group [Time frame: During the baseline]
• Sensitivity for patients which had recent mammography [Time frame: During the baseline]
• Patient satisfaction questionnaire [Time frame: During the baseline]
• MammoWave sensitivity in BC [Time frame: During the baseline)]
• MammoWave specificity and sensitivity using RadioSpin simulator [Time frame: During the Baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Screening

Study locations

Italy · 3 centers

• IRCCS Policlinico San Martino — Genova
• Ospedale San Giovanni Battista - USL Umbria 2 — Foligno
• Az. San. Univ. Giuliano Isontina (ASU GI) — Trieste

Spain · 1 center

• Hospital Universitario de Toledo — Toledo

Publications

• Alvarez Sanchez-Bayuela D, Ghavami N, Romero Castellano C, Bigotti A, Badia M, Papini L, Raspa G, Palomba G, Ghavami M, Loretoni R, Calabrese M, Tagliafico A, Tiberi G. A Multicentric, Single Arm, Prospective, Stratified Clinical Investigation to Confirm MammoWave's Ability in Breast Lesions Detection. Diagnostics (Basel). 2023 Jun 17;13(12):2100. doi: 10.3390/diagnostics13122100. PMID 37370995

Identifiers

NCT: NCT05300464 · UBT 2022-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗