The study was a multicentre, observational, cross-sectional, open and monitored trial involving 274 females who were subject to an examination using liquid crystal contact thermography device as a complementary tool to standard diagnostic imaging procedures of the breast glands. The study was conducted in specialist outpatient clinics. Patients were eligible to participate in the study upon signing the informed consent form. There was no follow up after the thermographic examination. The study will comprise of a single registration of thermographic images of the breasts which will be subjected to automatic and expert analysis by radiologists.
Study Type
OBSERVATIONAL
Enrollment
274
Patient undergo contact thermography examination with the use of liquid crystal contact thermography device- Braster.
Diagnostic efficacy of liquid crystal contact thermography using a manual assessment algorithm as compared with ultrasound and/or mammography and breast biopsy.
C-statistic (area under receiver operator characteristic -ROC - curve) as measure of the ability of the thermographic findings to distinguish histologically-confirmed breast cancer from non-cancer, in women with abnormal breast ultrasound (BIRADS \>3), stratified by age (\<50 years; ≥50 years)
Time frame: 2 years
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