Clinical trial NCT05009277: Study To Evaluate The Sensitivity Of The Linda Thermal Device
Official title: Study To Evaluate The Sensitivity Of The Linda Thermal Device In Relation To Mammography In The Detection Of Suspected Breast Neoplasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Device
Thermography
Mammography
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
Collaborators: name: Termo Health Tecnologia Ltda
First posted: 2021-08-17
Enrollment: 500
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: assess thermal sensitivity
timeFrame: assess thermal sensitivity immediatly after capturing the image
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hospital Vera Cruz
state: São Paulo
Study officials:
affiliation: Termo Health Tecnologia Ltda
name: Rubens F Mendrone
role: STUDY_CHAIR
References: