Collaborator:
Toscana Life Sciences Sviluppo s.r.l., 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 Hereditário (Portugal),
1. MammoWave® sensitivity (Time Frame - During the procedure): 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.
2. MammoWave® specificity (Time Frame - During the procedure): MammoWave® specificity (percentage of 'true negative' results) while using an optimized algorithm.
Secondary outcome:
1. Detection rates by type of lesion (Time Frame - During the baseline): Evaluation of the detection rates (sensitivity) according to the type of radiological finding (microcalcification, mass, asymmetry or architectural distortion group), also by breast density (according to BI-RADS ACR classification assigned by the radiologist), and comparison with the other standard screening and diagnostic modalities.
2. Recall rate (Time Frame - During the baseline): Evaluation of MammoWave recalls, also by breast density (according to BI-RADS ACR classification assigned by the radiologist), and comparison with the other standard screening and diagnostic modalities.
3. Positive-predictive value (Time Frame - During the baseline): Evaluation of MammoWave positive predictive value (for the biopsies performed), also by breast density (according to BI-RADS ACR classification assigned by the radiologist), and comparison with the other standard screening and diagnostic modalities.
4. Program screening rate (Time Frame - During the baseline): Program screening rate, calculated as the proportion of women diagnosed with BC in the study population
5. BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density (Time Frame - During the baseline): BC detection rates of each by histological type and size of the BC and BI-RADS classification, also by breast density
6. MammoWave® sensitivity and specificity after retrospective AI adjustment using the data at the end of the study (Time Frame - During the baseline): Evaluation of the improvement in both sensitivity and specificity when retrospectively using AI algorithms for the evaluation of MammoWave® data after its further optimization with all data collected in the participants included in the study.
7. Agreement between different evaluator (i.e. local versus central) (Time Frame - During the baseline): Evaluation of the reproducibility of results comparing the lectures performed at the study centers and the centralized lectures
8. Volunteers' satisfaction questionnaire (Time Frame - During the baseline): Volunteers' satisfaction through a properly designed questionnaire collecting women's issues and plus during the exam with MammoWave® in the language spoken by the women
MammoWave: Women undergoing conventional breast screening examination will be asked by the clinical staff if they are interested in taking part in the study.
A short visit should be performed to check the inclusion/exclusion criteria, review demographic data, and the volunteer's medical history. After performing this visit, the volunteers will perform the MammoWave exam on both their breasts.
The exam will be composed of two phases: data acquisition and data processing. During the acquisition, which should take about 8 minutes, the volunteers would be lying down in a prone position, on the bed which is part of MammoWave.
When the acquisition is completed, the data will be processed through a dedicated microwave imaging algorithm. The output will be composed of microwave images, plus parameters describing the images. MammoWave output will also comprise a label obtained using an optimized classification algorithm.
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"A Clinical Investigation to Evaluate Microwave Imaging Via MammoWave® in a Population-based Screening Program for Early Breast Cancer Detection"
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