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临床试验/NCT04121988
NCT04121988终止不适用

Prospective Observational Study of Diagnostic Yield in Cushing's Disease Using Deep Learning Based Denoising MRI

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
15
试验地点
1
主要终点
Detection rate of ACTH producing microadenoma

研究概览

简要总结

Negative MRI findings may occur in up to 40% of cases of ACTH producing microadenomas. The aim of the study is to evaluate if detection of ACTH producing microadenomas can be increased using deep learning based denoising MRI.

详细描述

Detecting ACTH producing microadenoma in MRI is important in establishing the diagnosis of Cushing disease and may enable patients to avoid additional diagnostic tests such as inferior petrosal sinus sampling. However, detecting ACTH producing microadenoma in MRI remains as a diagnostic challenge due its small size with its median diameter of 5-mm. Many attempts have been made in order to improve the sensitivity of detecting ACTH producing microadenoma. It is generally accepted as standard clinical practice to perform dynamic contrast enhanced T1 weighted image to delineate delayed enhancing microadenonoma in comparison to the background enhancement of the normal gland. Despite these attempts, negative MRI findings may occur in up to 40% of cases of ACTH producing microadenomas and there is a need to improve its detection rate. Theoretically, performing thin slice thickness scans should help detecting the lesion but this is unavoidably accompanied with increased level of noise. Deep learning based denoising algorithm can be applied to reduce the noise level and potentially increase the detection rate of ACTH producing microadenomas. The aim of the study is to evaluate if detection of ACTH producing microadenomas can be increased using deep learning based denoising MRI.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suspected of Cushing disease undergoing MRI
  • Signed informed consent

排除标准

  • Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
  • Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
  • Poor MRI image quality due to artifacts

结局指标

主要结局

Detection rate of ACTH producing microadenoma

时间窗: 2 months

Proportion of positive MRI with visible microadenoma as percentage (%)

次要结局

  • Proportion of patients undergoing additional diagnostic tests(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ho Sung Kim

Professor

Asan Medical Center

研究点 (1)

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