跳至主要内容
临床试验/NCT06664190
NCT06664190进行中(未招募)不适用

Study on Preoperative Imaging for Precise Prediction of Surgical Difficulty, Efficacy, and Risks in Pituitary Adenoma Surgeries

Huashan Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年8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)
入组人数
200
试验地点
1
主要终点
Extent of resection

研究概览

简要总结

Pituitary adenomas (PAs) are among the most prevalent lesions of the sella turcica, accounting for 10%-25% of all intracranial neoplasms. Pituitary macroadenomas (PMAs) are defined with a maximum diameter of over 1 cm. Tumor characteristics are key factors influencing surgical effectiveness and complications of PMAs, with tumor perfusion and consistency identified as major predictive factors in literature. Conventional sequences provide limited information for predicting the perfusion and consistency of pituitary adenomas. Advanced sequences offer additional insights. However, the efficacy of combining radiomic features from multiparametric sequences, incorporating both conventional and advanced sequences, has not yet been proved.

We aim to develop machine learning models that combines radiomic features developed from both conventional and advanced sequences to predict the perfusion and consistency of PMAs. Furthermore, we aim to demonstrate the clinically applicability of these models by constructing a MR-PIT stratification (Multiparametric Radiomic derived and tumor Perfusion and consIsTency based surgical difficulty stratification), which correlated with the surgical strategy and outcomes.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • patients with tumor more than 2.5 cm of maximal diameter in the coronal plane
  • Functional and non-functional pituitary tumors

排除标准

  • incomplete image data

结局指标

主要结局

Extent of resection

时间窗: From enrollment to the end of treatment at 12 weeks

次要结局

  • Severe postoperative complications(From enrollment to the end of treatment at 12 weeks)

研究者

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

Zhaoyun Zhang

Professor

Huashan Hospital

研究点 (1)

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