NCT04268251CompletedNot Applicable
Prospective MRI Evaluation of Cavernous Sinus Invasion by Pituitary Adenoma Using Deep Learning Based Denoising
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Asan Medical Center
- Enrollment
- 67
- Locations
- 2
- Primary Endpoint
- Cavernous sinus invasion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Cavernous sinus invasion
Time Frame: Within 1 week
Presence or absence of cavernous sinus invasion determined surgically
Secondary Outcomes
- Size of pituitary adenoma (in mm), laterality of pituitary adenoma (unilateral or bilateral) on the MRI(Within 1 week)
- Margin of pituitary adenoma (well-delineated, poorly delineated) on the MRI(Within 1 week)
Investigators
Ho Sung Kim
Professor
Asan Medical Center
Study Sites (2)
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