Study To Evaluate The Sensitivity Of The Linda Thermal Device

Mammography Clinical Trial

— LINDA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05009277
• Other study ID #: LINDA
• Status: Recruiting
• Start date: August 30, 2021
• Est. completion date: January 30, 2023

Study information

• Verified date: October 2022
• Source: Azidus Brasil
• Contact: Rubens F Mendrone
• Phone: +5511942576409
• Email: rubensfm[@]projetolinda.com.br
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Mammography
• Thermography

Intervention

Device:
• Device
LINDA thermal device

Locations

Country	Name	City	State
Brazil	Hospital Vera Cruz	Campinas	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Azidus Brasil	Termo Health Tecnologia Ltda

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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