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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858738
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
Clinmark Clinical Research
Information provided by (Responsible Party):
Braster S.A.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




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)



Information from the National Library of Medicine

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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.

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

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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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors