DeviceLINDANCT05009277
Study To Evaluate The Sensitivity Of The Linda Thermal Device
An observational study of Device and Thermography, run by Azidus Brasil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 40 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Device, Thermography, Mammography
- What is being tested?
- Device
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Aug 2021to 30 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Vera Cruz
Campinas, São Paulo
Florentino de Araujo Cardoso Filho, MD, PhD, +55 19 991232882, florentino.cardoso@hospitalcare.com.br
Luciana Ferrara, +55 19 981428814, luciana.ferrara@azidusbrasil.com.br
About this study
Official title: 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.
Read the 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.
- Conditions
- Device, Thermography, Mammography
- Being tested
- Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeviceDevice
Also called LINDA
LINDA thermal device
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: assess thermal sensitivity immediatly after capturing the image
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start30 Aug 2021
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Termo Health Tecnologia Ltda
- Responsible party
- Sponsor
- Investigators
- Rubens F Mendrone, Study chair, Termo Health Tecnologia Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009277
- Sponsor's protocol ID
- LINDA
- Acronym
- LINDA
- Status last verified
- Oct 2022
- First submitted
- 8 Jun 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study To Evaluate The Sensitivity Of The Linda Thermal Device In Relation To Mammography In The Detection Of Suspected Breast Neoplasia
- ClinicalTrials.gov ID
- NCT05009277
- Acronym / sponsor ID
- LINDA / LINDA
- Conditions
- Device, Thermography, Mammography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Collaborators
- Termo Health Tecnologia Ltda
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DeviceAlso: LINDALINDA thermal device | Device | – |
Primary outcome
assess thermal sensitivity
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubens F Mendrone study chair
Termo Health Tecnologia Ltda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Device and Thermography, run by Azidus Brasil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rubens F Mendrone (+5511942576409, rubensfm@projetolinda.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess thermal sensitivity (time frame: assess thermal sensitivity immediatly after capturing the image). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.