Evaluation of Cavernous Sinus Invasion by Pituitary Adenoma Using Deep Learning Based Denoising MR

Study Overview
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Brief Summary
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Preoperative evaluation of cavernous sinus invasion by pituitary adenoma is critical for performing safe operation and deciding on surgical extent as well as for treatment success. Because of the small size of the pituitary gland and sellar fossa, determining the exact relationship between the pituitary adenoma and cavernous sinus can be challenging. Performing thin slice thickness MRI may be beneficial but is inevitably associated with increased noise level. By applying deep learning based denoising algorithm, diagnosis of cavernous sinus invasion by pituitary adenoma may be improved.

Official Title
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Prospective MRI Evaluation of Cavernous Sinus Invasion by Pituitary Adenoma Using Deep Learning Based Denoising

Conditions
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Cavernous Sinus Invasion by Pituitary Adenoma

Intervention / Treatment
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* Diagnostic Test: MRI with deep learning based denoising


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing preoperative brain MR for pituitary adenoma Exclusion Criteria: Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential Poor MRI image quality due to artifacts

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Deep learning based denoising MR<br>1 mm slice thickness coronal contrast-enhanced T1 weighted imaging with deep learning based denoising vs. 3 mm slice thickness coronal contrast-enhanced T1 weighted imaging | Diagnostic Test: MRI with deep learning based denoising<br>* 1-mm coronal contrast-enhanced T1 weighted image with deep learning based denoising<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cavernous sinus invasion | Presence or absence of cavernous sinus invasion determined surgically | Within 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of pituitary adenoma (in mm), laterality of pituitary adenoma (unilateral or bilateral) on the MRI | Size of the tumor (in mm), laterality of the tumor (unilateral or bilateral) on the MRI | Within 1 week | 
| Margin of pituitary adenoma (well-delineated, poorly delineated) on the MRI | Margin of pituitary adenoma (well-delineated, poorly delineated) on the MRI | Within 1 week |