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临床试验/CTRI/2019/04/018586
CTRI/2019/04/018586
尚未招募
不适用

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

Cura health care Pvt ltd1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月5日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
Cura health care Pvt ltd
入组人数
100
试验地点
1
主要终点
Descriptive study of thermographic images and correlation with routine conventional imaging (Mammography and supplementary Ultrasonography)

概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
Female

入选标准

  • 1.Positive finding on MMG. 2.Age between 18 to 75 years. 3.Willingness to participate in the study.

排除标准

  • Patients who cannot lie down in prone position.
  • Febrile patients.
  • Pregnant and lactating women.
  • Patients who cannot follow the instructions during the study.

结局指标

主要结局

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

时间窗: 6 months

次要结局

  • To assess the diagnostic accuracy of thermography with conventional work up as gold standard.(6 months)

研究者

发起方
Cura health care Pvt ltd
申办方类型
Other [Healthcare industry]

研究点 (1)

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