NCT03735550

Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts

Investigation of the Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts Compared to Standard Diagnostic Methods of Breast Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Jagiellonian University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Contact thermographic breast examination device	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.

Timeline

• Start date: 2017-02-01
• Primary completion: 2019-01-30
• Completion: 2019-01-31
• First posted: 2018-11-08
• Last updated: 2018-12-20

Locations

24 sites across 1 country: Poland