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

NCT ID: NCT06664190

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-06-01

Brief Summary

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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

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Conditions

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Pituitary Adenoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Advanced 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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoyun Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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KY2022-709

Identifier Type: -

Identifier Source: org_study_id

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