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

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

Identifiant de l'essai ICTRP
NCT06291896 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
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)

Titre académique
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)

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

Maladie en cours d'investigation
Women's Health: Neoplasm of Breast (ICTRP)

Intervention étudiée
Device: MammoWave (ICTRP)

Type d'essai
Interventional (ICTRP)

Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label). (ICTRP)

Critères d'inclusion/exclusion
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 disponible

Critères d'évaluation principaux et secondaires
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)

Date d'enregistrement
non disponible

Inclusion du premier participant
non disponible

Sponsors secondaires
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)

Contacts supplémentaires
Gianluigi Tiberi, gianluigi@ubt-tech.com, 0039 3490564302 (ICTRP)

ID secondaires
UBT 2023-01 (ICTRP)

Résultats-Données individuelles des participants
non disponible

Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06291896 (ICTRP)