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.
Study Type
OBSERVATIONAL
Enrollment
3,000
A class 2a medical device being an active non-invasive multiple-use thermographic contact tester that uses a technology of passive liquid crystal matrices placed in the head of the device that records a thermographic image of breast glands with application of these matrices to the examined organ. The examination is non-invasive.
BIAŁOSTOCKIE CENTRUM ONKOLOGII im. Marii Skłodowskiej - Curie
Bialystok, Poland
Diagnostic efficacy of liquid crystal contact thermography using a manual assessment algorithm as compared with ultrasound and/or mammography and breast biopsy.
The outcome is measured as number of subjects with pathological diagnosis of cancer. Subjects will be analysed based on age, 18-49 and women over 50.
Time frame: 2 years
Validation of new algorithms for automatic interpretation of thermographic images of the breast gland assessed by sensitivity, specificity, positive and negative predicate values with 95% confidence intervals using Jeffrey's method.
Comparison of the field below the Receiver Operating Characteristic (ROC) curve (C statistic) and sensitivity and specificity between the age and recruitment groups as well as between the manual algorithm and automatic interpretation algorithm will take place with the use of Wald and McNemar tests. Values P \< 0.05 will be recognised as statistically significant.
Time frame: 6 months
Safety of liquid crystal contact thermography device assessed by absolute and relative number of adverse events relating to the investigated medical device and patient groups. The data is collected in electronic Case Report Form (eCRF).
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
"Zakład Radiologii i Diagnostyki Obrazowej, Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny"
Brzozów, Poland
CM MEDYK
Częstochowa, Poland
LUX MED.
Gdansk, Poland
Klinika Artvein
Gdansk, 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"
Krakow, Poland
...and 14 more locations