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Clinical Trials/NCT06664190
NCT06664190
Active, not recruiting
Not Applicable

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

Huashan Hospital1 site in 1 country200 target enrollmentAugust 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pituitary Adenoma
Sponsor
Huashan Hospital
Enrollment
200
Locations
1
Primary Endpoint
Extent of resection
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
June 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zhaoyun Zhang

Professor

Huashan Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • incomplete image data

Outcomes

Primary Outcomes

Extent of resection

Time Frame: From enrollment to the end of treatment at 12 weeks

Secondary Outcomes

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

Study Sites (1)

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