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

NCT03735550 | Unknown

• 1 other identifier: INNOMED_BRASTER_2016_01
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 24

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.

Conditions

Breast Cancer

Keywords

breast cancer; contact thermography; thermography; liquid crystal contact thermography; efficacy; breast neoplasm

Outcome Measures

Primary Outcomes (1)

• Diagnostic efficacy of liquid crystal contact thermography using a manual assessment algorithm as compared with ultrasound and/or mammography and breast biopsy.

  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.

  2 years

Secondary Outcomes (2)

• 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.

  6 months

• 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).

  2 years

Study Arms (3)

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

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

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

Interventions

Contact thermographic breast examination device 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 A age: 18-49; Group B age: 50 and above; Group C 18-49; 50 and above

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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:
• 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.
• 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). -

You may not qualify if:

• A visible, considerable breasts asymmetry that makes the examination with an equal number of matrix applications on both breasts impossible.
• 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.
• Previous or ongoing anti-tumour treatment due to the breast cancer.
• Symptomatic acute or chronic breast inflammation, with visible features of inflammation: pain, increased temperature, skin redness, swelling, breast abscesses, breast vessels thrombosis.
• Injury to the breasts with visible clinical properties of extravasation.
• A patient is suffering from an active infection with the body temperature equal to or more than 37.5°C.
• 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).
• Alcohol consumption on the day of the visit at the doctor's.
• Intensive physical effort up to 30 minutes before thermographic examination.
• Bath/shower (approximately 2 hours before thermographic examination).
• Using sauna/ steam bath on the day of examination, before thermographic examination.
• 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).
• A direct stay close to the heat or cold sources such as heaters or air conditioners 30 minutes before thermographic examination.

Sponsors & Collaborators

• Jagiellonian University: lead
• National Center for Research and Development, Poland: collaborator
• Braster S.A.: collaborator
• Bioscience, S.A.: collaborator

Study Sites (24)

BIAŁOSTOCKIE CENTRUM ONKOLOGII im. Marii Skłodowskiej - Curie

Bialystok, 15-027, Poland

Location

"Zakład Radiologii i Diagnostyki Obrazowej, Szpital Specjalistyczny w Brzozowie Podkarpacki Ośrodek Onkologiczny"

Brzozów, 36-200, Poland

Location

CM MEDYK

Częstochowa, 42-200, Poland

Location

LUX MED.

Gdansk, 80-207, Poland

Location

Klinika Artvein

Gdansk, 80-456, Poland

Location

NZOZ INTERMED Sp. z o.o.

Gryfino, 74-100, Poland

Location

Centrum Medyczne Femina

Katowice, 40-703, Poland

Location

NZOZ Promont MED.

Kielce, 20-050, Poland

Location

KOMED

Konin, 62-550, Poland

Location

"Centrum Medyczne Zdrowie Kobiety"

Krakow, 30-114, Poland

Location

Gabinety Babie Lato

Krakow, 31-036, Poland

Location

Niepubliczy Zakład Opieki Zdrowotnej Polikmed

Krakow, 31-115, Poland

Location

Zakład Radiologii i Diagnostyki Obrazowej Centrum Onkologii Instytut im. Marii Skłodowskiej-Curie Oddział w Krakowie

Krakow, 31-115, Poland

Location

SP ZOZ Szpital Uniwersytecki w Krakowie

Krakow, 31-501, Poland

Location

Centrum Medyczne Salve Medica

Lodz, 91-211, Poland

Location

WWCOT w Łodzi

Lodz, Poland

Location

Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli

Lublin, 20-090, Poland

Location

ONKO-TEAM Diagnostyka

Poznan, 61-104, Poland

Location

Centrum Medyczne Miła

Warsaw, 00-001, Poland

Location

"Centrum Profilaktyki Nowotworów Centrum Onkologii Instytut im. Marii Skłodowskiej-Curie "

Warsaw, 02-781, Poland

Location

Specjalistyczna Przychodnia Lekarska WILMED

Warsaw, 02-954, Poland

Location

NZOZ i POZ Centrum Medyczne Saska Kępa

Warsaw, 03-977, Poland

Location

Mazowiecki Szpital Onkologiczny

Wieliszew, 05-135, Poland

Location

Zakład Diagnostyki Chorób Piersi Dolnośląskie Centrum Onkologii we Wrocławiu

Wroclaw, 53-413, Poland

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Paweł Basta, MD PhD

  Collegium Medicum Jagiellonian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Department of Gynaecology and Oncology Jagiellonian University, Medical College

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 8, 2018
• Study Start: February 1, 2017
• Primary Completion: January 30, 2019
• Study Completion: January 31, 2019
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (24)