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

Not Applicable

Completed

• Conditions: Cavernous Sinus Invasion by Pituitary Adenoma
• Interventions: Diagnostic Test: MRI with deep learning based denoising

• Registration Number: NCT04268251
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-12
• Study First Submitted: 2020-01-13
• Study First Submitted QC: 2020-02-11
• Study First Posted: 2020-02-13
• Primary Completion: 2020-08-30
• Study Completion: 2022-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-12
• Last Update Posted: 2024-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Patients undergoing preoperative brain MR for pituitary adenoma

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep learning based denoising MR	MRI with deep learning based denoising	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

Primary Outcome Measures

Name	Time	Method
Cavernous sinus invasion	Within 1 week	Presence or absence of cavernous sinus invasion determined surgically

Secondary Outcome Measures

Name	Time	Method
Size of pituitary adenoma (in mm), laterality of pituitary adenoma (unilateral or bilateral) on the MRI	Within 1 week	Size of the tumor (in mm), laterality of the tumor (unilateral or bilateral) on the MRI
Margin of pituitary adenoma (well-delineated, poorly delineated) on the MRI	Within 1 week	Margin of pituitary adenoma (well-delineated, poorly delineated) on the MRI

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of