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OpenTrials
Active, Not Recruiting

NCT Number: NCT06664190

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advanced sequences, such as arterial spin labeling (ASL) and diffusion-weighted imaging (DWI)

Diagnostic Test

Advanced sequences, such as arterial spin labeling (ASL) and diffusion-weighted imaging (DWI)

Primary outcomes

  1. Extent of resection

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

Secondary outcomes

  1. Severe postoperative complications

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

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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