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Clinical Trials/CTRI/2019/04/018586
CTRI/2019/04/018586
Not yet recruiting
Not Applicable

Descriptive study of thermographic images and correlation with routine conventional imaging (Mammography and supplementary Ultrasonography)

Cura health care Pvt ltd1 site in 1 country100 target enrollmentStarted: August 5, 2019Last updated:

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 .

  1. Patients who cannot lie down in prone position.

  2. 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)

Investigators

Sponsor
Cura health care Pvt ltd
Sponsor Class
Other [Healthcare industry]

Study Sites (1)

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