Clinical validation of a microwave-based medical device for breast cancer screening

Italy, Poland, Portugal, Spain, Switzerland (ICTRP)

ID di studio ICTRP
NCT06291896 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
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 (BASEC)

Titolo accademico
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 (ICTRP)

Titolo pubblico
A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave? in a Population-based Screening Program for Early Breast Cancer Detection (ICTRP)

Malattie studiate
Women's Health: Neoplasm of Breast (ICTRP)

Intervento studiato
Device: MammoWave (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
Gender: Female
Maximum age: 74 Years
Minimum age: 45 Years
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 (ICTRP)

non disponibile

Endpoint primari e secondari
MammoWave? sensitivity;MammoWave? specificity (ICTRP)

Detection rates by type of lesion;Recall rate;Positive-predictive value;Program screening rate;BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density;MammoWave? sensitivity and specificity after retrospective AI adjustment using the data at the end of the study;Agreement between different evaluator (i.e. local versus central);Volunteers' satisfaction questionnaire (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
London South Bank University;ELAROS 24/7 Limited (UK);Servicio De Salud De Castilla La Mancha (Spain);IMT School for Advanced Studies Lucca;EVITA - Cancro Heredit?rio (Portugal);Fondazione Toscana Life Sciences (Italy) (ICTRP)

Contatti aggiuntivi
Gianluigi Tiberi, gianluigi@ubt-tech.com, 0039 3490564302 (ICTRP)

ID secondari
UBT 2023-01 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06291896 (ICTRP)