Diagnostic Yield of Deep Learning Based Denoising MRI in Cushing's Disease

Pituitary ACTH Secreting Adenoma Clinical Trial

Official title:

Prospective Observational Study of Diagnostic Yield in Cushing's Disease Using Deep Learning Based Denoising MRI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04121988
• Other study ID #: AsanMCHSKim_04
• Status: Terminated
• Start date: January 10, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: May 2024
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Detecting ACTH producing microadenoma in MRI is important in establishing the diagnosis of Cushing disease and may enable patients to avoid additional diagnostic tests such as inferior petrosal sinus sampling. However, detecting ACTH producing microadenoma in MRI remains as a diagnostic challenge due its small size with its median diameter of 5-mm. Many attempts have been made in order to improve the sensitivity of detecting ACTH producing microadenoma. It is generally accepted as standard clinical practice to perform dynamic contrast enhanced T1 weighted image to delineate delayed enhancing microadenonoma in comparison to the background enhancement of the normal gland. Despite these attempts, negative MRI findings may occur in up to 40% of cases of ACTH producing microadenomas and there is a need to improve its detection rate. Theoretically, performing thin slice thickness scans should help detecting the lesion but this is unavoidably accompanied with increased level of noise. Deep learning based denoising algorithm can be applied to reduce the noise level and potentially increase the detection rate 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients suspected of Cushing disease undergoing MRI
• Signed informed consent

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

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Adenoma
• Pituitary ACTH Hypersecretion
• Pituitary ACTH Secreting Adenoma

Intervention

Diagnostic Test:
• MRI
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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Law 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 1:1-5. doi: 10.3171/2017.9.JNS171969. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection rate of ACTH producing microadenoma	Proportion of positive MRI with visible microadenoma as percentage (%)	2 months
Secondary	Proportion of patients undergoing additional diagnostic tests	Proportion of patients undergoing additional diagnostic tests as percentage (%)	6 months