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Brief Title: Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts
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
Study ID: NCT03735550
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
BIA艁OSTOCKIE CENTRUM ONKOLOGII im. Marii Sk艂odowskiej - Curie, Bia艂ystok, , Poland
"Zak艂ad Radiologii i Diagnostyki Obrazowej, Szpital Specjalistyczny w Brzozowie Podkarpacki O艣rodek Onkologiczny", Brzoz贸w, , Poland
CM MEDYK, Cz臋stochowa, , Poland
LUX MED., Gda艅sk, , Poland
Klinika Artvein, Gda艅sk, , Poland
NZOZ INTERMED Sp. z o.o., Gryfino, , Poland
Centrum Medyczne Femina, Katowice, , Poland
NZOZ Promont MED., Kielce, , Poland
KOMED, Konin, , Poland
"Centrum Medyczne Zdrowie Kobiety", Krak贸w, , Poland
Gabinety Babie Lato, Krak贸w, , Poland
Niepubliczy Zak艂ad Opieki Zdrowotnej Polikmed, Krak贸w, , Poland
Zak艂ad Radiologii i Diagnostyki Obrazowej Centrum Onkologii Instytut im. Marii Sk艂odowskiej-Curie Oddzia艂 w Krakowie, Krak贸w, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie, Krak贸w, , Poland
Centrum Onkologii Ziemi Lubelskiej im. 艣w. Jana z Dukli, Lublin, , Poland
ONKO-TEAM Diagnostyka, Pozna艅, , Poland
Specjalistyczna Przychodnia Lekarska WILMED, Warsaw, , Poland
Centrum Medyczne Mi艂a, Warszawa, , Poland
"Centrum Profilaktyki Nowotwor贸w Centrum Onkologii Instytut im. Marii Sk艂odowskiej-Curie ", Warszawa, , Poland
NZOZ i POZ Centrum Medyczne Saska K臋pa, Warszawa, , Poland
Mazowiecki Szpital Onkologiczny, Wieliszew, , Poland
Zak艂ad Diagnostyki Chor贸b Piersi Dolno艣l膮skie Centrum Onkologii we Wroc艂awiu, Wroc艂aw, , Poland
Centrum Medyczne Salve Medica, 艁贸d藕, , Poland
WWCOT w 艁odzi, 艁贸d藕, , Poland
Name: Pawe艂 Basta, MD PhD
Affiliation: Collegium Medicum Jagiellonian University
Role: PRINCIPAL_INVESTIGATOR