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| Name | Class |
|---|---|
| Termo Health Tecnologia Ltda | INDUSTRY |
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The LINDA thermal device consists of a thermal camera attachable to a cell phone and an application for connection with an artificial intelligence program based on a convolutional neural network for classification of thermographic breast images. The system is previously fed with thermographic images of the breast and their respective results/diagnostics. The images are processed in an automated way and return a percentage of chance of having a pathological pattern.
The LINDA thermal device consists of a thermal camera attachable to a cell phone and an application for connection with an artificial intelligence program based on a convolutional neural network for classification of thermographic breast images. The system is previously fed with thermographic images of the breast and their respective results/diagnostics. The images are processed in an automated way and return a percentage of chance of having a pathological pattern.
nfrared imaging (thermography) was approved as an auxiliary imaging modality for mammography by the Food and Drug Administration (FDA) in 1982. Thermography is a non-invasive, non-contact method without ionizing radiation, which is why its use can be prolonged and repeated. This technique allows for an evaluation of the functionality of the structures, which is why it is considered a physiological test and records the variation in the surface temperature of the human body based on the infrared radiation emitted by the surface of that body. It is capable of detecting tumor lesions since cancer cells generate heat due to the release of nitric oxide in the blood, causing changes in microcirculation, vasodilation, neo-angiogenesis and increased metabolic activity of cancer cells. Thus, in the initial stage of breast cancer, when it has not yet caused anatomical changes, there will be physiological changes that will lead to an increase in blood flow and metabolic activity. This increase induces a temperature rise in the area which will then be detected by thermography.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device | Device | LINDA thermal device |
|
| Measure | Description | Time Frame |
|---|---|---|
| assess thermal sensitivity | The primary objective of the study is to assess the thermal sensitivity of the LINDA device in detecting suspected breast cancer compared to mammography. | assess thermal sensitivity immediatly after capturing the image |
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Inclusion Criteria:
Exclusion Criteria:
Female
The study population will be composed of female subjects between 40 and 69 years of age, which has performed a mammography during the past 6 months before inclusion and that has the result available and is willing to consent to have image captured via thermographic camera.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rubens F Mendrone | Contact | +5511942576409 | rubensfm@projetolinda.com.br | |
| Luciana MB Ferrara | Contact | +5519981428814 | talopespinheiro@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rubens F Mendrone | Termo Health Tecnologia Ltda | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Vera Cruz | Recruiting | Campinas | São Paulo | Brazil |
It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.
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| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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