A Prospective Pilot Study on Use of Liquid Crystal Contact Thermography to Detect Early Breast Cancer
Trial ID: NCT03858738
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2015-04-20
Completion date: 2016-08-19
Sponsor: Braster S.A.
Collaborators: Clinmark Clinical Research
Conditions: Breast Cancer
Interventions: Thermographic breast examination performed by Braster device
Enrollment: 274
Age range: 25 Years - None
Sex: FEMALE

Summary:
The study was a multicentre, observational, cross-sectional, open and monitored trial involving 274 females who were 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 was conducted in specialist outpatient clinics. Patients were eligible to participate in the study upon signing the informed consent form. There was 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.

Eligibility criteria:
Inclusion Criteria:

Arm A:

1. Woman aged 25-49 years
2. Patient who had breast ultrasound done and classified according to the BI-RADS US classification, and the result was in category 4 or 5.
3. Patient with indications for biopsy unless breast biopsy was performed in the last 3 months (except for FNA).
4. Patient is able to read and understand the Patient Information Sheet and provided informed consent for participation in the study and disclosing medical data from the diagnostic process of the breast.

Arm B:

1. Woman aged 25-49 years or 50 years and above.
2. Patient who had breast ultrasound done and classified according to the BI-RADS US classification, and the result was in category 1 or 2.
3. Patient is able to read and understand the Patient Information Sheet and provided informed consent for participation in the study and disclosing medical data from the diagnostic process of the breast.

Arm C:

1. Woman aged 50 years or over.
2. Patient who had breast ultrasound done and classified according to the BI-RADS US classification, and the result was in category 4 or 5.
3. Patient with indications for biopsy unless breast biopsy was performed in the last 3 months (except for FNA).
4. Patient is able to read and understand the Patient Information Sheet and provided informed consent for participation in the study and disclosing medical data from the diagnostic process of the breast.

Exclusion Criteria:

For arms A and C

1. Patient after invasive diagnostic procedures of a breast lesion (a procedure performed less than 3 months prior to enrollment) - applies to CNB and MMT, does not apply to FNA.
2. Patient in the course of active infection with body temperature higher than 37.5°C.
3. Patient with symptomatic acute or chronic inflammation within the breast, visible signs of inflammation: pain, increased warmth, skin redness, oedema, breast abscesses, thrombosis.
4. Patient after trauma in the breast area with visible clinical signs of extravasation.
5. Patient in the course of oncological treatment for breast cancer.
6. Patient after breast surgery within 12 months prior to inclusion.
7. Patient with a history of conserving surgery for breast cancer (within 12 months after treatment).
8. Pregnant or breast-feeding patient.
9. Patient who consumed alcohol up to 2 hours before thermographic examination.
10. Patient after intense physical activity up to 30 minutes before thermographic examination.

Outcomes:
Diagnostic efficacy of liquid crystal contact thermography using a manual assessment algorithm as compared with ultrasound and/or mammography and breast biopsy.