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临床试验/NCT06234553
NCT06234553进行中(未招募)不适用

Radiomics-based Diagnosis, Treatment and Outcome Prediction for Pituitary Adenoma

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
Recurrence rate of pituitary adenoma

研究概览

简要总结

The images of patients with Pituitary adenoma were collected and analyzed based on the methods of radiomics.

详细描述

Inclusion of pituitary adenoma patients diagnosed clinically or pathologically

  1. Clinical data and pre-treatment imaging data of included patients (DICOM format)
  2. Determine the subtype diagnosis of pituitary adenoma based on the patient's clinical and pathological data
  3. Collect relevant data of patients before and after treatment
  4. Using radiomics methods, extract radiomic features of patients and construct a radiomic model for predicting the diagnosis and treatment response of pituitary adenomas

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gender unlimited, 18-80 years old;
  • Clinical diagnosis of Pituitary Adenoma and receive surgical treatment;
  • Received brain imaging;
  • informed consent signed

排除标准

  • Pregnant / lactating women
  • Contraindications of imaging examination
  • Lack of effective clinical data
  • MRI data before treatment cannot be obtained
  • Postoperative pathology not revealed pituitary adenoma

结局指标

主要结局

Recurrence rate of pituitary adenoma

时间窗: 1 year after treatment

The pituitary adenoma recurred 1 year after treatment. The recurrence was assessed by 3 aspects: (1)contrast enhanced MRI showed suspicious tumor growth, such as bone destruction; (2)signs and symptoms that had disappeared after treatment reappeared, such as pressing on nearby nerve tissue and some characteristic appearance; (3)endocrine indexes rose again after reaching the remission standard, iculding Prolactin(PRL)\>30 μg/L in Lactotroph adenoma; growth hormone (GH)\>2.5ng/ml in Somatotroph adenoma, serum cortisol\>800nmol/L at 8am in Corticotroph adenoma, while other types do not consider endocrine indicators.

次要结局

  • Pathological type of pituitary adenomas(1 week after treatment)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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