Using MammoWave to detect breast lesions
A Clinical Investigation (multicentric, Single Arm, Prospective, Stratified) to Confirm the Ability of MammoWave (microwave Mammogram) in Breast Lesions Detection
This study is testing a new device called MammoWave that uses microwave technology to see if it can find breast lesions better than traditional x-rays, and it's open to women of all ages.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Umbria Bioengineering Technologies Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 3 sites (Genova, Genova and 2 other locations) |
| Trial ID | NCT05300464 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to confirm the effectiveness of the MammoWave device in detecting breast lesions using microwave technology instead of traditional x-rays. The study will involve 600 participants across multiple centers in Italy, Germany, and Spain, with a focus on optimizing imaging algorithms and comparing results with standard diagnostic methods. Participants will undergo a quick and safe examination while lying comfortably, making it suitable for women of all ages and conditions. The study will assess the device's ability to detect both malignant and benign lesions.
Who should consider this trial
Good fit: Ideal candidates for this study are adult women aged 18 and older who have had a recent mammography report.
Not a fit: Patients who are pregnant, breastfeeding, or have implanted electronic devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more efficient method for breast cancer detection.
How similar studies have performed: While this approach is innovative, similar studies using microwave technology for breast imaging have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Genova, Genova and 2 other locations
- IRCCS Policlinico San Martino — Genova, Genova, Italy (Recruiting)
- Ospedale San Giovanni Battista - USL Umbria 2 — Foligno, Perugia, Italy (Not_yet_recruiting)
- Hospital Universitario de Toledo — Toledo, Spain, Spain (Recruiting)
Study contacts
- Study coordinator: Gianluigi Tiberi
- Email: gianluigi@ubt-tech.com
- Phone: 0039 34900564302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.