Breast CancerNCT03858738
A Pilot Study on Use of Liquid Crystal Contact Thermography to Detect Early Breast Cancer
An observational study of Breast Cancer, run by Braster S.A..
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Thermographic breast examination performed by Braster device
- Type of treatment
- Medical device
- How many people
- 274 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2015to 19 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Prospective 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.
- Conditions
- Breast Cancer
- Being tested
- Thermographic breast examination performed by Braster device
- Keywords
- breast cancer, breast pathology, malignancy, artificial intelligence, liquid crystal contact thermography, automatic algorithms, efficacy, sensitivity, specificity
- Medical subject headings
- Breast Neoplasms, Neoplasms, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermographic breast examination performed by Braster deviceDevice
Also called BRASTER™- IIa medical device, thermographic contact tester
Patient undergo contact thermography examination with the use of liquid crystal contact thermography device- Braster.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Thermographic breast examination performed by Braster device | |
| 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. Receives: Device: Thermographic breast examination performed by Braster device | |
| 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. Receives: Device: Thermographic breast examination performed by Braster device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy of liquid crystal contact thermography using a manual assessment algorithm as compared with ultrasound and/or mammography and breast biopsy.
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start20 Apr 2015
- Primary completion8 Jun 2016
- Study completion19 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braster S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinmark Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858738
- Sponsor's protocol ID
- ThermaAlg
- Status last verified
- Feb 2019
- First submitted
- 27 Feb 2019
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Study on Use of Liquid Crystal Contact Thermography to Detect Early Breast Cancer
- ClinicalTrials.gov ID
- NCT03858738
- Acronym / sponsor ID
- ThermaAlg
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breast pathology, malignancy, artificial intelligence, liquid crystal contact thermography, automatic algorithms, efficacy, sensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Braster S.A.Industry (pharma, biotech, devices)
- Collaborators
- Clinmark Clinical Research
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- 8 Jun 2016 (actual)
- Study completion
- 19 Aug 2016 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A: women aged 25-49 years | – | Device: Thermographic breast examination performed by Braster devicePatient 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. |
| Group B: Women aged 25-49 years or 50 ≥ | – | Device: Thermographic breast examination performed by Braster devicePatient 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. |
| Group C: Woman aged 50 years or over | – | Device: Thermographic breast examination performed by Braster devicePatient 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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.
- Woman aged 25-49 years or 50 years and above.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermographic breast examination performed by Braster deviceAlso: BRASTER™- IIa medical device, thermographic contact testerPatient undergo contact thermography examination with the use of liquid crystal contact thermography device- Braster. | Device | Group B: Women aged 25-49 years or 50 ≥, Group C: Woman aged 50 years or over, group A: women aged 25-49 years |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Braster S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.