Pre-operative Surgical Difficulty Stratification Using Predicted Tumor Perfusion and Consistency

Active, not recruiting

• Conditions: Pituitary Adenoma

• Registration Number: NCT06664190
• Lead Sponsor: Huashan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-27
• Study First Submitted QC: 2024-10-27
• Last Update Submitted: 2024-10-27
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-01-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extent of resection	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Severe postoperative complications	From enrollment to the end of treatment at 12 weeks

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China