A Pilot Study on Use of Liquid Crystal Contact Thermography to Detect Early Breast Cancer

NCT ID: NCT03858738

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 274 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-20
• Study Completion Date: 2016-08-19

Brief 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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

group A: women aged 25-49 years

Patient who had breast ultrasound done and classified according to the BI-RADS US classification, and the result was in category 4 or 5.

Patient with indications for biopsy unless breast biopsy was performed in the last 3 months (except for FNA). Thermography examination was performed with the use of Braster device.

Thermographic breast examination performed by Braster device

Intervention Type: DEVICE

Patient undergo contact thermography examination with the use of liquid crystal contact thermography device- Braster.

Group B: Women aged 25-49 years or 50 ≥

Patient who had breast ultrasound done and classified according to the BI-RADS US classification, and the result was in category 1 or 2.Thermography examination was performed with the use of Braster device.

Thermographic breast examination performed by Braster device

Intervention Type: DEVICE

Patient undergo contact thermography examination with the use of liquid crystal contact thermography device- Braster.

Group C: Woman aged 50 years or over

Patient who had breast ultrasound done and classified according to the BI-RADS US classification, and the result was in category 4 or 5. Patient with indications for biopsy unless breast biopsy was performed in the last 3 months (except for FNA). Thermography examination was performed with the use of Braster device.

Thermographic breast examination performed by Braster device

Intervention Type: DEVICE

Patient undergo contact thermography examination with the use of liquid crystal contact thermography device- Braster.

Interventions

Thermographic breast examination performed by Braster device

Patient undergo contact thermography examination with the use of liquid crystal contact thermography device- Braster.

Intervention Type: DEVICE

Other Intervention Names

BRASTER™- IIa medical device, thermographic contact tester

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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Clinmark Clinical Research

UNKNOWN

Sponsor Role: collaborator

Braster S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ThermaAlg

Identifier Type: -

Identifier Source: org_study_id