Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts
NCT ID: NCT03735550
Last Updated: 2018-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3000 participants
OBSERVATIONAL
2017-02-01
2019-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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National Center for Research and Development, Poland
OTHER
Braster S.A.
INDUSTRY
Bioscience, S.A.
INDUSTRY
Jagiellonian University
OTHER
Responsible Party
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Pawel Basta
Ass. Prof. Department of Gynaecology and Oncology Jagiellonian University, Medical College
Principal Investigators
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Paweł Basta, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Collegium Medicum Jagiellonian University
Locations
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BIAŁOSTOCKIE CENTRUM ONKOLOGII im. Marii Skłodowskiej - Curie
Bialystok, , Poland
"Zakład Radiologii i Diagnostyki Obrazowej, Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny"
Brzozów, , Poland
CM MEDYK
Częstochowa, , Poland
LUX MED.
Gdansk, , Poland
Klinika Artvein
Gdansk, , Poland
NZOZ INTERMED Sp. z o.o.
Gryfino, , Poland
Centrum Medyczne Femina
Katowice, , Poland
NZOZ Promont MED.
Kielce, , Poland
KOMED
Konin, , Poland
"Centrum Medyczne Zdrowie Kobiety"
Krakow, , Poland
Gabinety Babie Lato
Krakow, , Poland
Niepubliczy Zakład Opieki Zdrowotnej Polikmed
Krakow, , Poland
Zakład Radiologii i Diagnostyki Obrazowej Centrum Onkologii Instytut im. Marii Skłodowskiej-Curie Oddział w Krakowie
Krakow, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Centrum Medyczne Salve Medica
Lodz, , Poland
WWCOT w Łodzi
Lodz, , Poland
Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
Lublin, , Poland
ONKO-TEAM Diagnostyka
Poznan, , Poland
Centrum Medyczne Miła
Warsaw, , Poland
"Centrum Profilaktyki Nowotworów Centrum Onkologii Instytut im. Marii Skłodowskiej-Curie "
Warsaw, , Poland
Specjalistyczna Przychodnia Lekarska WILMED
Warsaw, , Poland
NZOZ i POZ Centrum Medyczne Saska Kępa
Warsaw, , Poland
Mazowiecki Szpital Onkologiczny
Wieliszew, , Poland
Zakład Diagnostyki Chorób Piersi Dolnośląskie Centrum Onkologii we Wrocławiu
Wroclaw, , Poland
Countries
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Other Identifiers
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INNOMED_BRASTER_2016_01
Identifier Type: -
Identifier Source: org_study_id