Skip to main content
OpenTrials
Completed

NCT Number: NCT03858738

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Arm A:

  • Woman 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).
  • 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:

  • Woman aged 25-49 years or 50 years and above.
  • Patient who had breast ultrasound done and classified according to the BI-RADS US classification, and the result was in category 1 or 2.
  • 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:

  • 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).
  • 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

  • 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.
  • Patient in the course of active infection with body temperature higher than 37.5°C.
  • Patient with symptomatic acute or chronic inflammation within the breast, visible signs of inflammation: pain, increased warmth, skin redness, oedema, breast abscesses, thrombosis.
  • Patient after trauma in the breast area with visible clinical signs of extravasation.
  • Patient in the course of oncological treatment for breast cancer.
  • Patient after breast surgery within 12 months prior to inclusion.
  • Patient with a history of conserving surgery for breast cancer (within 12 months after treatment).
  • Pregnant or breast-feeding patient.
  • Patient who consumed alcohol up to 2 hours before thermographic examination.
  • Patient after intense physical activity up to 30 minutes before thermographic examination.

Treatment and study plan

Thermographic breast examination performed by Braster device

Device

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

Other names: BRASTER™- IIa medical device, thermographic contact tester

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Braster S.A.

Industry

Collaborators

  • Clinmark Clinical Research

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 1, 2019
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.