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临床试验/NCT02829021
NCT02829021已完成不适用

Dynamic Infrared Thermography in Breast Cancer Diagnostics. A Diagnostic Accuracy Study Comparing Dynamic Infrared Thermography Against Mammography (Reference Standard)

University Hospital of North Norway2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2009年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
168
试验地点
2
主要终点
Diagnostic accuracy of Thermography compared with Mammography and breast biopsy.

研究概览

简要总结

This study evaluate diagnostic accuracy of dynamic infrared thermography compared to mammography (reference test) in breast cancer diagnostics. Women aged 50-70 years, selected for assessment after mammography screening were invited to dynamic infrared thermography before clinical mammography and further examination.

详细描述

This study evaluate diagnostic accuracy of dynamic infrared thermography compared to mammography (reference test) in breast cancer diagnostics.

Dynamic infrared thermography (DIRT) is an imagine procedure offering a non-invasive, painless examination without risk of radiation. Dynamic infrared thermography does not provide information on the morphological characteristics of the breast, rather it provides functional information on thermal and vascular conditions of the tissue (Fitzgerald, 2012).

During the study period from April 2009 until June 2012, a total of 168 women aged 50-70 years who were recalled for assessment after positive mammography screening were offered dynamic infrared thermography before further tests (clinical mammography, clinical examination and if necessary breast tissue biopsy).

Radiographers at the Breast Diagnostic Center (BDS) at University Hospital North Norway collected information about parity, menopausal status, use of hormone therapy and size of bra.

The same radiographers also carried out all the dynamic infrared thermography examinations. PI Åshild O. Miland and Professor James B. Mercer interpreted the thermograms and entered the data into the thermography database. Both were blinded for further assessments (mammography, clinical examination and biopsy) and non of them talked to any of the participants after the examination.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • aged 50-69
  • attending the Norwegian Breast Screening Program,
  • recalled for assessment after positive mammography screening

排除标准

  • not attending the Norwegian Breast Screening Program,
  • recalled to mammography for other reason than positive screening mammogram.

结局指标

主要结局

Diagnostic accuracy of Thermography compared with Mammography and breast biopsy.

时间窗: Baseline

Can thermography distinguish benign from malign tumours in breast cancer diagnostics. The gold standard is breast biopsy pathology. The outcome is measured as number of subjects with pathological diagnosis of cancer.

次要结局

未报告次要终点

研究者

发起方
University Hospital of North Norway
申办方类型
Other
责任方
Sponsor

研究点 (2)

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