Descriptive study of thermographic images and correlation with routine conventional imaging (Mammography and supplementary Ultrasonography)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cura health care Pvt ltd
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Descriptive study of thermographic images and correlation with routine conventional imaging (Mammography and supplementary Ultrasonography)
Overview
Brief Summary
R****Rotational breast thermography
Rotational thermography is a novel technique, developed upon conventional thermography, in order to over1come these limitations. Illumina360° (a system for rotational breast thermography) images 360° views of one breast at a time in two different controlled temperatures when is in a freely suspended state. Since the breast is positioned freely into the controlled environment maintained in the device and as the imaging is done using IR camera which is always at a distance from the breast that is being imaged, it is non-invasive, without any radiation and breast compression, without any contact of the camera onto the breast, thus being highly safe and accurate for surface temperature measurements.
Primary objective
Descriptive study of thermographic images and correlation with routine conventional imaging (Mammography and supplementary Ultrasonography)
Secondary objective
To assess the diagnostic accuracy of thermography with conventional work up as gold standard.
Inclusion Criteria
1.Positive finding on MMG.
2.Age between 18 to 75 years.
3.Willingness to participate in the study - YES
Exclusion criteria .
-
Patients who cannot lie down in prone position.
-
Febrile patients. 3. Pregnant and lactating women. 4. Patients who cannot follow the instructions during the study. .
Implications
The study will help to evaluate the significance of the new thermal imaging device, ILLUMINA360° for use in breast cancer screening by comparing with the recommended gold standard imaging practice.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Positive finding on MMG. 2.Age between 18 to 75 years. 3.Willingness to participate in the study.
Exclusion Criteria
- •Patients who cannot lie down in prone position.
- •Febrile patients.
- •Pregnant and lactating women.
- •Patients who cannot follow the instructions during the study.
Outcomes
Primary Outcomes
Descriptive study of thermographic images and correlation with routine conventional imaging (Mammography and supplementary Ultrasonography)
Time Frame: 6 months
Secondary Outcomes
- To assess the diagnostic accuracy of thermography with conventional work up as gold standard.(6 months)