Braster

The study was a multicentre, observational, cross-sectional, open and monitored trial involving approx. 3000 females who were subject to an examination using a liquid crystal contact thermography device (Braster device model BRA 1.0.) as a complementary tool to standard diagnostic imaging procedures of the breast glands. The study was conducted in specialist outpatient clinics. It comprised a single registration of thermographic images of the breasts which were subjected to

Primary objective of the study is to determine and compare the diagnostic efficacy of breast thermography using the Braster device model BRA 1.0.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 had 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 presented 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.

The report from the studies is currently under preparation.

INNOMED survey - the largest Polish multicenter observational study conducted by Collegium Medicum of the Jagiellonian University.

The study was a multicentre, observational, cross-sectional, open and monitored trial involving approx. 3000 females who were subject to an examination using a liquid crystal contact thermography device (Braster device model BRA 1.0.) as a complementary tool to standard diagnostic imaging procedures of the breast glands. The study was conducted in specialist outpatient clinics. It comprised a single registration of thermographic images of the breasts which were 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 the Braster device model BRA 1.0.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

• Group A - age: 18-49 years; with the result of a USG / MMG diagnostic examination classified as BIRADS 4-5;

• Group B - age ≥ 50 years; with the result of a USG / MMG diagnostic examination classified as BIRADS 4-5;

• Group C - age: C1: 18-49 and C2: ≥ 50 years; with the result of a USG / MMG diagnostic test classified as BIRADS 1-2;

The study involved, among others, such centers as:

• University Hospital in Krakow

• Center of Oncology. Maria Skłodowska-Curie Branch in Krakow

• Center of Oncology. Maria Skłodowska-Curie in Warsaw

• Lower Silesian Center of Oncology in Wroclaw

• Oncology Center Maria Skłodowska - Curie in Bialystok

• Center of Oncology of the Lublin Region St. John of Dukla

• Provincial Specialist Hospital. M. Kopernika in Łódź