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

• ClinicalTrials.gov Identifier: NCT03858738
• Recruitment Status: Completed
• First Posted: March 1, 2019
• Last Update Posted: March 4, 2019
• Sponsor: Braster S.A.
• Collaborator: Clinmark Clinical Research
• Information provided by (Responsible Party): Braster S.A.

Study Description

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.

Condition or disease	Intervention/treatment
Breast Cancer	Device: Thermographic breast examination performed by Braster device

Study Design

• Study Type: Observational
• Actual Enrollment: 274 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: A Prospective Pilot Study on Use of Liquid Crystal Contact Thermography to Detect Early Breast Cancer
• Actual Study Start Date: April 20, 2015
• Actual Primary Completion Date: June 8, 2016
• Actual Study Completion Date: August 19, 2016

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Device: Thermographic breast examination performed by Braster device; Patient undergo contact thermography examination with the use of liquid crystal contact thermography device- Braster.; Other Name: BRASTER™- IIa medical device, thermographic contact tester
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.	Device: Thermographic breast examination performed by Braster device; Patient undergo contact thermography examination with the use of liquid crystal contact thermography device- Braster.; Other Name: BRASTER™- IIa medical device, thermographic contact tester
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.	Device: Thermographic breast examination performed by Braster device; Patient undergo contact thermography examination with the use of liquid crystal contact thermography device- Braster.; Other Name: BRASTER™- IIa medical device, thermographic contact tester

Outcome Measures

Primary Outcome Measures :

1. Diagnostic efficacy of liquid crystal contact thermography using a manual assessment algorithm as compared with ultrasound and/or mammography and breast biopsy. [ Time Frame: 2 years ]
   C-statistic (area under receiver operator characteristic -ROC - curve) as measure of the ability of the thermographic findings to distinguish histologically-confirmed breast cancer from non-cancer, in women with abnormal breast ultrasound (BIRADS >3), stratified by age (<50 years; ≥50 years)

Eligibility Criteria

• Ages Eligible for Study: 25 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Women were eligible if they underwent a breast ultrasound (with outcome BIRADS 1-5), had no breast surgery over the previous year, no core biopsy over the previous 3 months, no previously-diagnosed breast cancer, were not pregnant or lactating, and had no symptoms/signs of local or generalized infection. Those recruited signed an informed consent form that also gave permission to use medical information (clinical characteristics, ultrasound, mammography and pathology findings) for study purposes. A total of 274 women, 25 years of age and older, were recruited consecutively between June 2015 and April 2016. Mammography was performed in some patients below 50 years and in all women of 50 years or over. The thermographic examination was performed after breast ultrasound.

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Braster S.A.
• ClinicalTrials.gov Identifier: NCT03858738
• Other Study ID Numbers: ThermaAlg
• First Posted: March 1, 2019
• Last Update Posted: March 4, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Braster S.A.:

breast cancer; breast pathology; malignancy; artificial intelligence; liquid crystal contact thermography; automatic algorithms; efficacy; sensitivity; specificity

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases