Study Stopped
Patients recruitment was difficult and the primary author quitted her role.
Diagnostic Yield of Deep Learning Based Denoising MRI in Cushing's Disease
Prospective Observational Study of Diagnostic Yield in Cushing's Disease Using Deep Learning Based Denoising MRI
1 other identifier
observational
15
1 country
1
Brief Summary
Negative MRI findings may occur in up to 40% of cases of ACTH producing microadenomas. The aim of the study is to evaluate if detection of ACTH producing microadenomas can be increased using deep learning based denoising MRI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
January 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedMay 14, 2024
May 1, 2024
3.1 years
October 8, 2019
May 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Detection rate of ACTH producing microadenoma
Proportion of positive MRI with visible microadenoma as percentage (%)
2 months
Secondary Outcomes (1)
Proportion of patients undergoing additional diagnostic tests
6 months
Study Arms (1)
Denoising MRI group
Patients suspected of Cushing disease undergoing deep learning based denoising MRI
Interventions
1 mm slice thickness with deep learning based reconstruction algorithm applied to the following sequences: * Coronal T2 weighted imaging * Dynamic contrast enhanced T1 weighted imaging * Coronal contrast enhanced T1 weighted imaging
Eligibility Criteria
Patients of tertiary hospital center
You may qualify if:
- Patients suspected of Cushing disease undergoing MRI
- Signed informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, South Korea
Related Publications (2)
Grober Y, Grober H, Wintermark M, Jane JA, Oldfield EH. Comparison of MRI techniques for detecting microadenomas in Cushing's disease. J Neurosurg. 2018 Apr;128(4):1051-1057. doi: 10.3171/2017.3.JNS163122. Epub 2017 Apr 28.
PMID: 28452619BACKGROUNDLaw M, Wang R, Liu CJ, Shiroishi MS, Carmichael JD, Mack WJ, Weiss M, Wang DJJ, Toga AW, Zada G. Value of pituitary gland MRI at 7 T in Cushing's disease and relationship to inferior petrosal sinus sampling: case report. J Neurosurg. 2018 Mar 23;130(2):347-351. doi: 10.3171/2017.9.JNS171969. Print 2019 Feb 1.
PMID: 29570013BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ho Sung Kim, MD PhD
Asan Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 8, 2019
First Posted
October 10, 2019
Study Start
January 10, 2020
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
May 14, 2024
Record last verified: 2024-05