Clinical trial NCT03735550: Effectiveness of Liquid Crystal Contact Thermography in Detecting Pathological Changes in Female Breasts
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
contact thermography
thermography
liquid crystal contact thermography
efficacy
breast neoplasm
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: National Center for Research and Development, Poland
name: Braster S.A.
name: Bioscience, S.A.
First posted: 2018-11-08
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Diagnostic efficacy of liquid crystal contact thermography using a manual assessment algorithm as compared with ultrasound and/or mammography and breast biopsy.
timeFrame: 2 years
Secondary outcomes:
measure: 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.
timeFrame: 6 months
measure: 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).
timeFrame: 2 years
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: BIAŁOSTOCKIE CENTRUM ONKOLOGII im. Marii Skłodowskiej - Curie
city: Brzozów
country: Poland
facility: "Zakład Radiologii i Diagnostyki Obrazowej, Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny"
city: Częstochowa
country: Poland
facility: CM MEDYK
city: Gdańsk
country: Poland
facility: LUX MED.
city: Gdańsk
country: Poland
facility: Klinika Artvein
city: Gryfino
country: Poland
facility: NZOZ INTERMED Sp. z o.o.
city: Katowice
country: Poland
facility: Centrum Medyczne Femina
city: Kielce
country: Poland
facility: NZOZ Promont MED.
city: Konin
country: Poland
facility: KOMED
city: Kraków
country: Poland
facility: "Centrum Medyczne Zdrowie Kobiety"
city: Kraków
country: Poland
facility: Gabinety Babie Lato
city: Kraków
country: Poland
facility: Niepubliczy Zakład Opieki Zdrowotnej Polikmed
city: Kraków
country: Poland
facility: Zakład Radiologii i Diagnostyki Obrazowej Centrum Onkologii Instytut im. Marii Skłodowskiej-Curie Oddział w Krakowie
city: Kraków
country: Poland
facility: SP ZOZ Szpital Uniwersytecki w Krakowie
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
city: Poznań
country: Poland
facility: ONKO-TEAM Diagnostyka
city: Warsaw
country: Poland
facility: Specjalistyczna Przychodnia Lekarska WILMED
city: Warszawa
country: Poland
facility: Centrum Medyczne Miła
city: Warszawa
country: Poland
facility: "Centrum Profilaktyki Nowotworów Centrum Onkologii Instytut im. Marii Skłodowskiej-Curie "
city: Warszawa
country: Poland
facility: NZOZ i POZ Centrum Medyczne Saska Kępa
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny
city: Wrocław
country: Poland
facility: Zakład Diagnostyki Chorób Piersi Dolnośląskie Centrum Onkologii we Wrocławiu
city: Łódź
country: Poland
facility: Centrum Medyczne Salve Medica
city: Łódź
country: Poland
facility: WWCOT w Łodzi
Study officials:
affiliation: Collegium Medicum Jagiellonian University
name: Paweł Basta, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: