NCT05009277

Study To Evaluate The Sensitivity Of The Linda Thermal Device

Study To Evaluate The Sensitivity Of The Linda Thermal Device In Relation To Mammography In The Detection Of Suspected Breast Neoplasia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Azidus Brasil · Industry
• Sex: Female
• Age: 40 Years – 69 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Device
• Thermography
• Mammography

Interventions

Type	Name	Description
DEVICE	Device	LINDA thermal device

Timeline

• Start date: 2021-08-30
• Primary completion: 2023-01-30
• Completion: 2023-01-30
• First posted: 2021-08-17
• Last updated: 2022-10-27

Locations

1 site across 1 country: Brazil