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OpenTrials
Completed

NCT Number: NCT04268251

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

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.

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Key information

Conditions

Cavernous Sinus Invasion by Pituitary Adenoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI with deep learning based denoising

Diagnostic Test

1-mm coronal contrast-enhanced T1 weighted image with deep learning based denoising

Primary outcomes

  1. Cavernous sinus invasion

    Time frame: Within 1 week

    Presence or absence of cavernous sinus invasion determined surgically

Secondary outcomes

  1. Size of pituitary adenoma (in mm), laterality of pituitary adenoma (unilateral or bilateral) on the MRI

    Time frame: Within 1 week

    Size of the tumor (in mm), laterality of the tumor (unilateral or bilateral) on the MRI

  2. Margin of pituitary adenoma (well-delineated, poorly delineated) on the MRI

    Time frame: Within 1 week

    Margin of pituitary adenoma (well-delineated, poorly delineated) on the MRI

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Feb 13, 2020
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.