Study To Evaluate The Sensitivity Of The Linda Thermal Device

Recruiting

• Conditions: Mammography; Thermography; Device

• Registration Number: NCT05009277
• Lead Sponsor: Azidus Brasil

Brief 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.

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-17
• Study Start: 2021-08-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27
• Primary Completion: 2023-01-30
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

1. Provide your signed and dated consent in duplicate;
2. Female, aged between 40 and 69 years;
3. Have had a mammography no more than 6 months before V1 and with results available in V1.

Exclusion Criteria

1. Fever (temperature above 37.8°C at rest) in the last 48 hours before image capture by thermography;
2. Exposure to natural or artificial light for chest tanning for less than three (3) days before performing the thermography;
3. Pregnant or breastfeeding women in the last 6 months;
4. Physical exercise 3 h before performing the thermography;
5. To have performed a breast biopsy less than 6 months after the thermography;
6. Other conditions that, at the investigator's discretion, increase the risk to the patient or make her unsuitable for the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assess thermal sensitivity	assess thermal sensitivity immediatly after capturing the image	The primary objective of the study is to assess the thermal sensitivity of the LINDA device in detecting suspected breast cancer compared to mammography.

Trial Locations

Locations (1)

Hospital Vera Cruz; 🇧🇷 Campinas, São Paulo, Brazil