Clinical trial · Interventional
A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection
A Multicentric, Prospective Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection to Make Breast Cancer Screening More Accurate, Inclusive, and Female-friendly
NCT06291896CI-TRIAL-00111455recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Women's Health: Neoplasm of Breast | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MammoWave | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm
- description
- All participants perform: conventional breast examination path (i.e., screening mammogram, integrated with other radiological/histological output when deemed necessary by the responsible Investigator in each site) AND MammoWave exam.
- interventionNames
- Device: MammoWave
Primary outcomes (2)
- measure
- MammoWave® sensitivity
- timeFrame
- During the procedure
- description
- MammoWave® sensitivity (percentage of 'true positive' results) while using an optimized classification algorithm. The Reference Standard is intended as the output of conventional breast examination path (i.e. screening mammogram, integrated with other radiological/histological output when deemed necessary by the responsible Investigator). Reference Standard may be: BC+ for the histology-confirmed and classified as BI-RADS 1,2 or 3.
- measure
- MammoWave® specificity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAlvarez Sanchez-Bayuela D, Fernandez Martin J, Tiberi G, Ghavami N, Giovanetti Gonzalez R, Cruz Hernanez LM, Aguilar Angulo PM, Martinez Gomez AD, Rodriguez Sanchez A, Bigotti A, Khalesi B, Pontoriero L, Calabrese M, Tagliafico AS, Romero Castellano C. Microwave imaging for breast cancer screening: protocol for an open, multicentric, interventional, prospective, non-randomised clinical investigation to evaluate cancer detection capabilities of MammoWave system on an asymptomatic population across multiple European countries. BMJ Open. 2024 Nov 2;14(11):e088431. doi: 10.1136/bmjopen-2024-088431. PMID 39488412