Clinical trial · Observational
Study To Evaluate The Sensitivity Of The Linda Thermal Device
Study To Evaluate The Sensitivity Of The Linda Thermal Device In Relation To Mammography In The Detection Of Suspected Breast Neoplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Device | — | UNRESOLVED | — |
| Mammography | — | UNRESOLVED | — |
| Thermography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- assess thermal sensitivity
- timeFrame
- assess thermal sensitivity immediatly after capturing the image
- description
- The primary objective of the study is to assess the thermal sensitivity of the LINDA device in detecting suspected breast cancer compared to mammography.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 69 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available