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Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts

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ClinicalTrials.gov Identifier: NCT03735550
Recruitment Status : Active, not recruiting
First Posted : November 8, 2018
Last Update Posted : December 20, 2018
Sponsor:
Collaborators:
National Center for Research and Development, Poland
Braster S.A.
Bioscience, S.A.
Information provided by (Responsible Party):
Pawel Basta, Jagiellonian University

Brief Summary:
The study is designed to evaluate the effectiveness of liquid crystal contact thermography in detecting pathological changes in female breasts compared to standard diagnostic methods.

Condition or disease Intervention/treatment
Breast Cancer Device: Contact thermographic breast examination device

Detailed Description:

The study is a multicentre, observational, cross-sectional, open and monitored trial involving approx. 3000 females who will be 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 is conducted in specialist outpatient clinics. Patients are eligible to participate in the study upon signing the informed consent form. There is 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.

Primary objective of the study is to determine and compare the diagnostic efficacy of breast thermography using a medical device based on liquid crystal contact thermography to standard of care.

The subjects were divided into three groups based on age and Breast Imaging Reporting and Data System (BI-RADS). Thermography was performed as a complementary modality to standard of care. In group A, the investigators recruited women aged 18-49, who has a breast ultrasound performed and a result of BI-RADS 4b, 4c or 5. In group B, the investigators recruited women over 50 years of age with either a result of BI-RADS 4, 4a, 4b, 4c or 5 on mammography or BI-RADS 4a, 4b, 4c or 5 on ultrasound. If a positive result was present on one of these examinations, the other examination needed to be performed. Lastly, in group C, the investigators recruited women aged 18 and above with a BI-RADS score of 1 or 2 on mammography and/or breast ultrasound.

Predicted duration of the study is approximately 24 months.


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Investigation of the Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts Compared to Standard Diagnostic Methods of Breast Cancer
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group A age: 18-49
Women aged 18-49 who had breast ultrasound performed with a result of BI-RADS 4b, 4c or 5. Thermography examination was performed with the use of contact thermographic breast examination device as a complementary tool to breast ultrasound. The planned number of participants in the group: n=700 people.
Device: Contact thermographic breast examination device
A class 2a medical device being an active non-invasive multiple-use thermographic contact tester that uses a technology of passive liquid crystal matrices placed in the head of the device that records a thermographic image of breast glands with application of these matrices to the examined organ. The examination is non-invasive.

Group B age: 50 and above
Women aged 50 and above who had mammography and/or breast ultrasound performed (both examinations are obligatory, i.e. if the subject was recruited based on mammography, then ultrasound must be performed and vice-versa). Women were recruited if they had a result of BI-RADS 4, 4a, 4b, 4c or 5 on mammography or BI-RADS 4a, 4b, 4c or 5 on ultrasound. Thermography examination was performed with the use of contact thermographic breast examination device as a complementary tool to the aforementioned techniques. The planned number of participants in the group: n=2100 people.
Device: Contact thermographic breast examination device
A class 2a medical device being an active non-invasive multiple-use thermographic contact tester that uses a technology of passive liquid crystal matrices placed in the head of the device that records a thermographic image of breast glands with application of these matrices to the examined organ. The examination is non-invasive.

Group C 18-49; 50 and above

Subgroup C1 (n=100 people): women aged 18-49 years, who underwent breast ultrasound with a result of BI-RADS 1 or 2.

Sub-group C2 (n=100 people): women aged 50 and above, who had mammography or breast ultrasound performed; with a result of BI-RADS 1 or 2 (both examinations are obligatory, i.e. if the subject was recruited based on mammography, then ultrasound must be performed and vice-versa).

Thermography examination was performed with the use of contact thermographic breast examination device as a complementary tool to the aforementioned techniques.

Device: Contact thermographic breast examination device
A class 2a medical device being an active non-invasive multiple-use thermographic contact tester that uses a technology of passive liquid crystal matrices placed in the head of the device that records a thermographic image of breast glands with application of these matrices to the examined organ. The examination is non-invasive.




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 ]
    The outcome is measured as number of subjects with pathological diagnosis of cancer. Subjects will be analysed based on age, 18-49 and women over 50.


Secondary Outcome Measures :
  1. Validation of new algorithms for automatic interpretation of thermographic images of the breast gland assessed by sensitivity, specificity, positive and negative predicate values with 95% confidence intervals using Jeffrey's method. [ Time Frame: 6 months ]

    Comparison of the field below the Receiver Operating Characteristic (ROC) curve (C statistic) and sensitivity and specificity between the age and recruitment groups as well as between the manual algorithm and automatic interpretation algorithm will take place with the use of Wald and McNemar tests.

    Values P < 0.05 will be recognised as statistically significant.


  2. Safety of liquid crystal contact thermography device assessed by absolute and relative number of adverse events relating to the investigated medical device and patient groups. The data is collected in electronic Case Report Form (eCRF). [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The planned number of patients included in the observational study is 3000 women aged 18 and above in which breast ultrasound or mammography were performed as a part of standard breast gland diagnostics, the key element of which is a final assessment of the study with the BI-RADS scale (Breast Imaging Reporting and Data System). Participants of the study will be divided into three cohorts based on age and results from breast ultrasound and/or mammography.
Criteria

Inclusion Criteria:

- a woman aged 18 or above (without any upper age limit) who gives informed consent to the participation in the study by signing the Informed Consent Form and meets one of the below requirements may take part in the study:

  1. For women aged 18-49: ultrasound imaging of breasts was performed; category of the final assessment of the study according to the BI-RADS scale 4b, 4c or 5.
  2. For women aged 50 or above (in the B group, a mammography examination in the final assessment category according to the BI-RADS scale 4, 4a, 4b, 4c or 5; or the breast ultrasound in the final assessment category according to the BI-RADS scale 4a, 4b, 4c or 5 (but both examinations are obligatory); in the C2 group, mammography or breast ultrasound in the final category of the examination assessment according to the BI-RADS scale 1, 2 (but both examinations are obligatory). -

Exclusion Criteria:

  1. Performed invasive diagnostics of changes in breasts (treatment performed less than 12 months before inclusion into the study) - relates to a core- needle and mammotome biopsy (also a fine-needle biopsy performed up to 4 weeks before inclusion to the study).
  2. A breast surgery within 12 months before inclusion into the study (including cosmetic surgeries, i.e. aesthetic implants, fat-graft transfer and hyaluronic acid injection into breasts.
  3. A visible, considerable breasts asymmetry that makes the examination with an equal number of matrix applications on both breasts impossible.
  4. A visible considerable breast deformation including appearance of scarring on the breast skin which makes adjustment of the entire matrix surface to the breast gland impossible.
  5. Previous or ongoing anti-tumour treatment due to the breast cancer.
  6. Symptomatic acute or chronic breast inflammation, with visible features of inflammation: pain, increased temperature, skin redness, swelling, breast abscesses, breast vessels thrombosis.
  7. Injury to the breasts with visible clinical properties of extravasation.
  8. A patient is suffering from an active infection with the body temperature equal to or more than 37.5°C.
  9. Pregnancy and lactation (pregnancy must be ruled out based on the last period date (< 30 days), or using effective contraception - with regard to women from group A, in case of any doubts performance of the stripe pregnancy test).
  10. Alcohol consumption on the day of the visit at the doctor's.
  11. Intensive physical effort up to 30 minutes before thermographic examination.
  12. Bath/shower (approximately 2 hours before thermographic examination).
  13. Using sauna/ steam bath on the day of examination, before thermographic examination.
  14. Cosmetic and beauty treatments before examination: peeling within the neckline and breasts, hair removal within armpits, application of cosmetics on the breast skin (approximately 2 hours before thermographic examination).
  15. A direct stay close to the heat or cold sources such as heaters or air conditioners 30 minutes before thermographic examination.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735550


Locations
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Poland
BIAŁOSTOCKIE CENTRUM ONKOLOGII im. Marii Skłodowskiej - Curie
Białystok, Poland, 15-027
"Zakład Radiologii i Diagnostyki Obrazowej, Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny"
Brzozów, Poland, 36-200
CM MEDYK
Częstochowa, Poland, 42-200
LUX MED.
Gdańsk, Poland, 80-207
Klinika Artvein
Gdańsk, Poland, 80-456
NZOZ INTERMED Sp. z o.o.
Gryfino, Poland, 74-100
Centrum Medyczne Femina
Katowice, Poland, 40-703
NZOZ Promont MED.
Kielce, Poland, 20-050
KOMED
Konin, Poland, 62-550
"Centrum Medyczne Zdrowie Kobiety"
Kraków, Poland, 30-114
Gabinety Babie Lato
Kraków, Poland, 31-036
Niepubliczy Zakład Opieki Zdrowotnej Polikmed
Kraków, Poland, 31-115
Zakład Radiologii i Diagnostyki Obrazowej Centrum Onkologii Instytut im. Marii Skłodowskiej-Curie Oddział w Krakowie
Kraków, Poland, 31-115
SP ZOZ Szpital Uniwersytecki w Krakowie
Kraków, Poland, 31-501
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin, Poland, 20-090
ONKO-TEAM Diagnostyka
Poznań, Poland, 61-104
Specjalistyczna Przychodnia Lekarska WILMED
Warsaw, Poland, 02-954
Centrum Medyczne Miła
Warszawa, Poland, 00-001
"Centrum Profilaktyki Nowotworów Centrum Onkologii Instytut im. Marii Skłodowskiej-Curie "
Warszawa, Poland, 02-781
NZOZ i POZ Centrum Medyczne Saska Kępa
Warszawa, Poland, 03-977
Mazowiecki Szpital Onkologiczny
Wieliszew, Poland, 05-135
Zakład Diagnostyki Chorób Piersi Dolnośląskie Centrum Onkologii we Wrocławiu
Wrocław, Poland, 53-413
Centrum Medyczne Salve Medica
Łódź, Poland, 91-211
WWCOT w Łodzi
Łódź, Poland
Sponsors and Collaborators
Jagiellonian University
National Center for Research and Development, Poland
Braster S.A.
Bioscience, S.A.
Investigators
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Principal Investigator: Paweł Basta, MD PhD Collegium Medicum Jagiellonian University

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Responsible Party: Pawel Basta, Ass. Prof. Department of Gynaecology and Oncology Jagiellonian University, Medical College, Jagiellonian University
ClinicalTrials.gov Identifier: NCT03735550     History of Changes
Other Study ID Numbers: INNOMED_BRASTER_2016_01
First Posted: November 8, 2018    Key Record Dates
Last Update Posted: December 20, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Pawel Basta, Jagiellonian University:
breast cancer
contact thermography
thermography
liquid crystal contact thermography
efficacy
breast neoplasm
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