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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04121988
Enrollment
15
Registered
2019-10-10
Start date
2020-01-10
Completion date
2023-02-28
Last updated
2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary ACTH Secreting Adenoma

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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTMRI

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

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Detection rate of ACTH producing microadenoma2 monthsProportion of positive MRI with visible microadenoma as percentage (%)

Secondary

MeasureTime frameDescription
Proportion of patients undergoing additional diagnostic tests6 monthsProportion of patients undergoing additional diagnostic tests as percentage (%)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026