Study To Evaluate The Sensitivity Of The Linda Thermal Device

NCT05009277 | Unknown

• 1 other identifier: LINDA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Device; Thermography; Mammography

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Device DEVICE

LINDA thermal device

Also known as: LINDA

Eligibility Criteria

• Age: 40 Years - 69 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azidus Brasil: lead
• Termo Health Tecnologia Ltda: collaborator

Study Sites (1)

Hospital Vera Cruz

Campinas, São Paulo, Brazil

RECRUITING

MeSH Terms

Interventions

Equipment and Supplies

Study Officials

• Rubens F Mendrone

  Termo Health Tecnologia Ltda

  STUDY CHAIR

Central Study Contacts

Rubens F Mendrone

CONTACT

+5511942576409; rubensfm@projetolinda.com.br

Luciana MB Ferrara

CONTACT

+5519981428814; talopespinheiro@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: August 17, 2021
• Study Start: August 30, 2021
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

BR (1)