Study To Evaluate The Sensitivity Of The Linda Thermal Device (LINDA)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Mammography; Thermography; Device
• Intervention / Treatment: Device: Device

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Rubens F Mendrone; Phone Number: +5511942576409; Email: rubensfm@projetolinda.com.br
• Study Contact Backup: Name: Luciana MB Ferrara; Phone Number: +5519981428814; Email: talopespinheiro@gmail.com

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil
      • Recruiting
      • Hospital Vera Cruz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Collaborators: Termo Health Tecnologia Ltda
• Investigators: Study Chair: Rubens F Mendrone, Termo Health Tecnologia Ltda

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 30, 2021
• Primary Completion (ANTICIPATED): January 30, 2023
• Study Completion (ANTICIPATED): January 30, 2023

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (ACTUAL): August 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: LINDA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No