NCT06291896 A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection
| NCT ID | NCT06291896 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Umbria Bioengineering Technologies |
| Condition | Women's Health: Neoplasm of Breast |
| Study Type | INTERVENTIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2024-03-15 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10,000 participants in total. It began in 2024-03-15 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an open, multicentric, interventional, prospective, non-randomized clinical investigation. The first aim of the study is to confirm that MammoWave reaches sensitivity\>75% and specificity\>90% in breast cancer (BC) detection on 10.000 volunteers undergoing regular screening programs.
Eligibility Criteria
Inclusion Criteria: * Women aged between 45 and 74 years * Asymptomatic * Signed informed consent form before starting any study activity * Average risk of BC (every woman except those with know BRCA1, 2, TP53, and/or previous BC) * Mammographic test, either 2D FFDM or 3D Digital Breast Tomosynthesis (DBT) (collecting oblique mediolateral projection \[MLO\] of the right breast, craniocaudal projection \[CC\] of the right breast, MLO projection of the left breast, CC projection of the left breast), performed within the past month with available results or planned to be performed in the same day of the MammoWave test or in the subsequent days * Spontaneous willingness to comply with CIP and recommendations Exclusion Criteria: * Woman with breast prostheses * Women with symptoms or some sign of suspected BC * Women with BRCA1, 2, TP53 or previous BC * Pregnant women * Women who do not have mammographic manifestation of the tumor (known occult breast tumor with only axillar manifestation) * Women with breast size larger than the largest MammoWave cup size
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06291896 clinical trial?
This trial is open to female participants only, aged 45 Years or older, up to 74 Years, studying Women's Health: Neoplasm of Breast. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06291896 currently recruiting?
Yes, NCT06291896 is actively recruiting participants. Contact the research team at gianluigi@ubt-tech.com for enrollment information.
Where is the NCT06291896 trial being conducted?
This trial is being conducted at Genova, Italy, Foligno, Italy, Trieste, Italy, Szczecin, Poland and 6 additional locations.
Who is sponsoring the NCT06291896 clinical trial?
NCT06291896 is sponsored by Umbria Bioengineering Technologies. The trial plans to enroll 10,000 participants.