Breast Cancer Clinical Trial
Official title:
Investigation of the Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts Compared to Standard Diagnostic Methods of Breast Cancer
The study is designed to evaluate the effectiveness of liquid crystal contact thermography in detecting pathological changes in female breasts compared to standard diagnostic methods.
The study is a multicentre, observational, cross-sectional, open and monitored trial
involving approx. 3000 females who will be 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 is conducted in specialist outpatient clinics. Patients are
eligible to participate in the study upon signing the informed consent form. There is 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.
Primary objective of the study is to determine and compare the diagnostic efficacy of breast
thermography using a medical device based on liquid crystal contact thermography to standard
of care.
The subjects were divided into three groups based on age and Breast Imaging Reporting and
Data System (BI-RADS). Thermography was performed as a complementary modality to standard of
care. In group A, the investigators recruited women aged 18-49, who has a breast ultrasound
performed and a result of BI-RADS 4b, 4c or 5. In group B, the investigators recruited women
over 50 years of age with either a result of BI-RADS 4, 4a, 4b, 4c or 5 on mammography or
BI-RADS 4a, 4b, 4c or 5 on ultrasound. If a positive result was present on one of these
examinations, the other examination needed to be performed. Lastly, in group C, the
investigators recruited women aged 18 and above with a BI-RADS score of 1 or 2 on mammography
and/or breast ultrasound.
Predicted duration of the study is approximately 24 months.
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