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TerminatedNCT04121988Updated May 14, 2024

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

An observational study in Pituitary ACTH Secreting Adenoma, sponsored by Asan Medical Center. Terminated at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-14.

Sponsored by Asan Medical Center · Observational

Why this study was terminated
Patients recruitment was difficult and the primary author quitted her role.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pituitary ACTH Secreting Adenoma
03

In context

Pituitary ACTH Hypersecretion

64 studies on the registry are indexed under Pituitary ACTH Hypersecretion; 16 are open to participants now.

This study's enrollment of 15 is below the median of 131 across 20 observational studies indexed under Pituitary ACTH Hypersecretion.

Browse Pituitary ACTH Hypersecretion studies →

Lead sponsor

Asan Medical Center is the lead sponsor of 578 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients of tertiary hospital center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients suspected of Cushing disease undergoing MRI
  • Signed

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
15 participants (actual)
Patient registry
No

Groups and cohorts

  • Denoising MRI group

    Patients suspected of Cushing disease undergoing deep learning based denoising MRI

    Diagnostic Test: 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

06

What researchers measure

Primary outcomes

  1. Detection rate of ACTH producing microadenoma

    Proportion of positive MRI with visible microadenoma as percentage (%)

    Time frame: 2 months

Secondary outcomes

  1. Proportion of patients undergoing additional diagnostic tests

    Proportion of patients undergoing additional diagnostic tests as percentage (%)

    Time frame: 6 months

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Study locations

1 site
  • Asan Medical Center
    Seoul, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 28452619 ↗
  • 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 23;130(2):347-351. doi: 10.3171/2017.9.JNS171969. Print 2019 Feb 1. PubMed 29570013 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04121988
Responsible party
Ho Sung Kim (Professor, Asan Medical Center) — Principal investigator
First posted
Oct 10, 2019
Start date
Jan 10, 2020
Primary completion
Feb 28, 2023
Completion
Feb 28, 2023
Last update
May 14, 2024

Study contacts

Ho Sung Kim, MD PhD
principal investigator · Asan Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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