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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06664190
Enrollment
200
Registered
2024-10-29
Start date
2022-08-01
Completion date
2025-06-01
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Adenoma

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.

Interventions

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

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

Sponsors

Huashan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Extent of resectionFrom enrollment to the end of treatment at 12 weeks

Secondary

MeasureTime frame
Severe postoperative complicationsFrom enrollment to the end of treatment at 12 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026